[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":558},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,43,67,89,112,134,160,184,205,224,246,266,286,310,331,352,375,395,413,436,455,479,498,517,537],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100053419","phase-1-hdm2005-combination-therapy-in-relapsedrefractory-mantle-cell-lymphoma-100053419",false,"NCT07697339","HDM2005 Combination Therapy in Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase Ib\u002FIII Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants aged 18 years or older.\n2. Histologically confirmed mantle cell lymphoma with cyclin D1 overexpression or documented t(11;14).\n3. Relapsed or refractory mantle cell lymphoma after prior treatment with an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor, unless a BTK inhibitor was not suitable or was not tolerated.\n4. At least one measurable lesion according to the 2014 Lugano response criteria.\n5. Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part.\n6. Adequate organ and bone marrow function as defined in the protocol.\n7. Estimated life expectancy of more than 3 months.\n8. Willingness to provide archived or fresh tumor tissue for central pathology review, if available.\n9. Willingness to follow the study treatment plan, visit schedule, and contraceptive requirements.\n10. Written informed consent provided before any study-specific procedures.\n\nExclusion Criteria:\n\n1. Leukemic non-nodal mantle cell lymphoma.\n2. Known central nervous system involvement by lymphoma.\n3. Prior treatment with a ROR1-targeted therapy.\n4. Active or uncontrolled infection requiring systemic treatment.\n5. Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol.\n6. History or current evidence of interstitial lung disease, active interstitial lung disease, or radiation pneumonitis requiring steroid treatment.\n7. Clinically significant cardiovascular or cerebrovascular disease that may increase study risk.\n8. Prior allogeneic hematopoietic stem cell transplantation with active or clinically significant graft-versus-host disease, or need for systemic immunosuppressive treatment for graft-versus-host disease.\n9. Prior solid organ transplantation.\n10. Other active malignancy or malignancy with a clinically significant risk of recurrence, except for certain adequately treated cancers as defined in the protocol.\n11. Unresolved clinically significant toxicity from prior anti-cancer therapy.\n12. Recent anti-cancer therapy, investigational treatment, major surgery, or radiotherapy within the protocol-defined washout period.\n13. Known allergy or contraindication to any study treatment or its components.\n14. Active autoimmune disease or immunodeficiency requiring systemic treatment, except for protocol-defined stable conditions.\n15. Pregnancy, breastfeeding, or planned pregnancy during the study.\n16. Any medical, psychiatric, laboratory, or social condition that, in the investigator's judgment, may interfere with study participation, study assessments, or participant safety.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase Ib\u002FIII, multicenter, open-label clinical study of HDM2005 in combination with rituximab and lenalidomide in adult patients with relapsed or refractory mantle cell lymphoma.\n\nMantle cell lymphoma is a type of non-Hodgkin lymphoma. Some patients have disease that comes back after treatment or does not respond well to available treatments. This study is designed to evaluate whether adding HDM2005 to rituximab and lenalidomide may provide clinical benefit for patients with relapsed or refractory mantle cell lymphoma who have previously received an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor.\n\nThe study includes two parts. In the Phase Ib part, participants will receive HDM2005 in combination with rituximab and lenalidomide. The main goals of this part are to evaluate the safety and tolerability of the combination, assess preliminary anti-tumor activity, and determine the recommended dose of HDM2005 for the Phase III part.\n\nIn the Phase III part, eligible participants will be randomly assigned to receive either HDM2005 at the recommended Phase III dose in combination with rituximab and lenalidomide, or the investigator's choice of comparator treatment with rituximab plus lenalidomide or bendamustine plus rituximab. The main goals of the Phase III part are to compare the anti-tumor activity and clinical benefit of the HDM2005 combination with the comparator treatments. The main measures of efficacy include objective response rate and progression-free survival, assessed according to the 2014 Lugano response criteria. The study will also evaluate safety, pharmacokinetics, immunogenicity, overall survival, duration of response, and other measures of anti-tumor activity.",[27],"Mantle Cell Lymphoma",[29,30],"ROR1-ADC","Mantle cell lymphoma","NOT_YET_RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-07-10",{"date":39,"type":21},"2028-12-01",{"name":41,"class":42},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100643476","phase-1-a-study-of-hdm2020-in-patients-with-advanced-sq-nsclc-100643476","NCT07638891","A Study of HDM2020 in Patients With Advanced Sq-NSCLC","A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HDM2020 in Patients With Advanced Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Participants who are able to understand and voluntarily sign a written Informed Consent Form (ICF) approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC), or their legally authorized representative (LAR), if applicable.\n2. Male or female participants aged 18 to 75 years.\n3. Participants must have histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous non-small cell lung cancer (sqNSCLC) that is not amenable to curative surgical resection, staged according to the 8th edition of the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer, and must have experienced treatment failure or intolerance to adequate prior standard-of-care therapy, including platinum-based chemotherapy and anti-PD-1\u002FPD-L1 therapy. The anti-PD-1\u002FPD-L1 therapy may have been administered as combination therapy or sequential therapy, or as neoadjuvant and\u002For adjuvant therapy (if a participant received neoadjuvant or adjuvant therapy and experienced relapse or progression during treatment or within 6 months of treatment completion, such therapy will be considered as failure of first-line standard-of-care treatment).\n4. Participants must provide archival or fresh tumor tissue samples for prospective FGFR2b expression testing; only participants with FGFR2b high-expression are eligible for enrollment.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.\n6. The expected survival time is \\>3 months.\n7. According to the RECIST v1.1, participants must have at least one measurable lesion.\n8. Laboratory test results during the screening period indicate that the participants have good organ function.\n9. Women of childbearing potential (WOCBP) must be willing to use two appropriate barrier methods of contraception from the time of signing informed consent until 7 months after the last dose of study treatment or use barrier contraception plus hormonal contraception to prevent pregnancy, or abstain from heterosexual intercourse throughout the study period; male participants must agree to take adequate contraceptive measures from the first dose of study treatment until 7 months after the last dose of study treatment.\n10. Participants with the willingness and ability to complete regular visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Participants with prior treatment with an ADC containing a topoisomerase I (Top I) inhibitor.\n2. Participants with active or chronic corneal disorders, history of corneal transplant, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulcer, other active eye disorders, and any clinically significant corneal disorders.\n3. Participants underwent major surgery within 4 weeks before the first dose; Participants received bone marrow or extensive radiotherapy within 4 weeks before the first dose; received local radiotherapy within 2 weeks before the first dose of the study drug; Participants continuously received systemic corticosteroids; Participants received standard chemotherapy, biological therapy, immunotherapies, any investigational medicinal product (IMP) and other systemic anti-tumor treatments within 4 weeks before the first dose.\n4. Participants with active malignant tumors within the past 5 years.\n5. Participants not recovered (recovered to ≤ Grade 1 or baseline) from relevant AEs resulting from prior treatments or other anti-cancer therapies.\n6. Participants with known active central nervous system (CNS) metastases.\n7. Participants with any of the following cardiovascular\u002Fcerebrovascular diseases\u002Fsymptoms\u002Findications: a) Mean resting QTc : ≥470 ms, ECG QTc measured three times within 10 min as the mean value; or those have a history or family history of congenital long QT syndrome; b) Any clinically significant abnormalities in resting ECG in rhythm, conduction, or morphology; c) Left ventricular ejection fraction (LVEF) \\\u003C50%; d) Participants with a history of myocardial contraction decreased and exhibited related symptoms within 6 months before study drug administration; e) Hypertension uncontrolled by drug therapy\n8. At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV).\n9. Presence of interstitial pneumonia, history of idiopathic pulmonary fibrosis, history of organising pneumonia, history of drug-induced pneumonia, history of idiopathic pneumonia, or evidence of active pneumonia found on chest computed tomography (CT) scan during the screening period; prior use of steroid pulse therapy due to pneumonia; Moderate or severe chronic obstructive pulmonary disease (COPD); Pulmonary malignant lymphangitis.\n10. Other diseases that may affect the efficacy and safety of the study drug, including but not limited to: a) Active infection requiring antibiotic therapy occurring within 2 weeks prior to the administration of study drug; b) Active autoimmune diseases or a history of autoimmune diseases; c) History of primary immunodeficiency; d) Active pulmonary tuberculosis; e) Participants who have had a clinically significant haemorrhage or significant haemorrhagic diathesis within 4 weeks before signing the informed consent; f) Any severe or uncontrolled systemic disease.\n11. Large amounts or symptomatic moderate amounts of pleural effusion, pericardial effusion, or ascites during the screening period, and still poorly controlled after treatments.\n12. Unstable thrombosis events requiring therapeutic intervention within 6 months before screening.\n13. A history of solid organ transplant.\n14. Known or suspected hypersensitivity to the study drug or its analogues.\n15. Pregnant and breastfeeding women.\n16. The investigator considers that the participant is not suitable to participate in this study.\n17. Participants who have received strong CYP3A4 inhibitors within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors during the study intervention period and within 30 days after the last dose.","75 Years",{"count":52,"type":21},150,[24],"The goal of this clinical trial is to learn if the study drug can treat in advanced squamous non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are:\n\nIs the drug safe and tolerable? Does the drug show antitumor activity? Participants will receive the study drug once(D1) or twice(D1.D8) every three weeks, and undergo imaging-based efficacy assessments every six weeks.",[56],"Squamous Non-small Cell Lung Cancer(NSCLC)","RECRUITING","2026-06-05",{"date":60,"type":35},"2026-06-10",{"date":62,"type":35},"2026-04-01",{"date":64,"type":21},"2027-11-03",{"name":41,"class":42},1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":66},"100639415","phase-1-a-phase-ibii-study-of-hdm2017-in-combination-with-standard-of-care-in-advanced-colorectal-cancer-100639415","NCT07621159","A Phase Ib\u002FII Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer","A Phase Ib\u002FII Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent.\n2. Male or female participants with age ≥ 18 years.\n3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.\n4. Be able to provide archived tumor tissue during the screening period.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Life expectancy ≥3 months.\n7. According to RECIST v1.1, participants must have at least one measurable lesion.\n8. Has adequate organ function.\n9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment.\n10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).\n2. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.\n3. Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.\n5. Known weight loss of \\>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.\n6. History of severe esophagogastric varicose vein, severe ulcer, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.\n7. Participants with current imaging or clinical evidence of significant gastrointestinal obstruction.\n8. Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose.\n9. Participants with known active CNS metastasis.\n10. Participants with cardiovascular\u002Fcerebrovascular disorder, symptoms, or manifestations.\n11. Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.",{"count":75,"type":21},120,[24,77],"PHASE2","This is a phase Ib\u002FII clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.",[80],"Colorectal Cancer Metastatic","2026-05-27",{"date":83,"type":35},"2026-06-02",{"date":85,"type":21},"2026-07-15",{"date":87,"type":21},"2028-11-01",{"name":41,"class":42},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":66},"100638960","phase-1-a-study-of-hdm1002-tablets-on-cardiac-repolarization-in-healthy-subjects-100638960","NCT07594847","A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects","A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects","Inclusion Criteria:\n\n* The subject has voluntarily signed a written informed consent form.\n* Male or female; age between 18 and 45 years (inclusive).\n* Subject's weight ≥50 kg, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm2, inclusive. BMI = weight (kg) \u002F height2 (m2).\n* Medical history inquiry, physical examination, laboratory test items, and other trial-related tests at screening are all normal or show mild abnormalities with no clinical significance, and the subject is judged to be eligible by the clinical research physician.\n* The subject is able to communicate well with the investigator and comply with the protocol requirements to complete the study.\n\nExclusion Criteria:\n\n* History of or current neurological\u002Fpsychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, or musculoskeletal system diseases, hepatic or renal insufficiency, or any other disease or physiological condition that may affect the study results;\n* Subjects with a personal or family history of medullary thyroid cancer (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2);\n* History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening;\n* History of a cholecystitis episode within 3 months prior to screening;\n* History of allergy to HDM1002, moxifloxacin hydrochloride tablets, other fluoroquinolones or quinolones, or any of the excipients; or history of food allergy, or a specific allergy history (asthma, urticaria, eczema, etc.);\n* Clinically significant major illness or undergone major surgery within 3 months prior to the trial;\n* Blood donation within 3 months, or plans to donate blood during this study, or transfusion or blood loss ≥200 mL within 4 weeks prior to the trial;\n* Has consumed a special diet, engaged in strenuous exercise, or had other factors that affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to dosing;\n* Pregnant or lactating, or has a positive blood pregnancy test result;\n* The investigator believes that the subject has any other condition that makes them unsuitable for participation in this clinical trial.",true,"45 Years",{"count":99,"type":21},72,[24],"The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT\u002FQTc interval in healthy subjects.",[103],"Healthy Adult Subject","2026-05-17",{"date":106,"type":35},"2026-05-19",{"date":108,"type":35},"2026-03-07",{"date":110,"type":21},"2026-11-06",{"name":41,"class":42},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":96,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":66},"100635942","phase-1-a-pharmacokinetic-study-of-hdm1005-injection-in-participants-with-impaired-renal-function-and-healthy-participants-100635942","NCT07559240","A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants","A Multicenter, Single-Dose, Parallel-Group, Open-Label Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants","Inclusion Criteria:\n\n* Aged between 18 and 75 years (inclusive), regardless of gender.\n* Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg\u002Fm² (inclusive).\n* For participants with renal impairment: prior diagnosis of chronic kidney disease (CKD). Absolute GFR calculated by CKD-EPI and BSA formula: ≥30 and \\\u003C60 mL\u002Fmin for moderate impairment; ≥15 and \\\u003C30 mL\u002Fmin for severe impairment.\n* For participants with normal renal function: aged 18 to 75 years (inclusive); body weight ≥50.0 kg (male) or ≥45.0 kg (female); BMI 19.0-35.0 kg\u002Fm².\n* In the investigator's opinion, suitable for the study based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.\n* Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.\n* Able to communicate well with the investigator and understand and comply with all study requirements.\n\nExclusion Criteria:\n\n* Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).\n* History of chronic pancreatitis, or an episode of acute pancreatitis or acute cholecystitis within 3 months prior to screening.\n* Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.\n* For the renal impairment group: presence of obstructive urinary tract disease, acute kidney injury, or other clinically significant systemic diseases beyond chronic kidney disease and its complications, which in the investigator's opinion make the participant unsuitable. For the normal renal function group: presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.\n* Known intolerance or allergy to GLP-1R and\u002For GIPR agonists, or known allergy to HDM1005 or any component of the formulation.\n* Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study.\n* Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing.\n* History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, cocaine) or positive urine drug test at screening.\n* History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture.\n* Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.",{"count":120,"type":21},30,[24],"The purpose of this study is to evaluate the pharmacokinetic profile and safety of a single subcutaneous injection of HDM1005 solution in participants with impaired kidney function compared to healthy participants.",[124,125],"Overweight","Obese","2026-05-05",{"date":128,"type":35},"2026-05-08",{"date":130,"type":21},"2026-05-15",{"date":132,"type":21},"2026-07-31",{"name":41,"class":42},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":66},"100634407","phase-1-a-study-of-hdm2024-in-participants-with-advanced-solid-tumors-100634407","NCT07539285","A Study of HDM2024 in Participants With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Efficacy of HDM2024 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed.\n* 2\\. Male or female participants aged 18 to 75 years (inclusive).\n* 3\\. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have experienced disease progression on or after standard therapy , or are intolerant to standard therapy, or for whom no effective standard of care is available.\n* 4\\. Participants who are able to provide fresh or archival tumor tissue during the screening period. Tumor tissue will be collected for biomarker testing at a central laboratory, including immunohistochemistry for EGFR and HER3 .\n* 5\\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 .\n* 6\\. Life expectancy ≥3 months.\n* 7\\. According to RECIST v1.1, the participant must have at least one measurable lesion .\n* 8\\. Participants with good organ function as demonstrated by screening laboratory test results.\n* 9\\. The fertile participants agreed to take effective contraceptive measures during the study and after its conclusion; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing.\n* 10\\. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* 1\\. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and\u002For HER3.\n* 2\\. Participants who have received the following treatments:\n\n  1. Participants who have undergone major surgery within 4 weeks before the first dose;\n  2. Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;\n  3. Participants who are receiving continuous systemic corticosteroid therapy ; low-dose corticosteroids are permitted if the dose of systemic corticosteroids has been stable for 4 weeks;\n  4. Participants who have received anti-tumor treatments within 4 weeks before the first dose, or are still within 5 half-lives of the last dose of the most recent anticancer therapy (whichever is longer). Traditional Chinese medicines with approved anticancer indications within 2 weeks prior to the first administration of study drug.\n* 3\\. Participants with other malignant tumor within the past 5 years, other than the tumor treated in this study, with the exception of locally cured tumors .\n* 4\\. Participants with related AEs (except for alopecia and ≤ Grade 2 sensory neuropathy) caused by previous treatment that have not recovered to ≤ Grade 1 or baseline level.\n* 5\\. Participants with known weight loss of \\>10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.\n* 6\\. Participants with serious complications or medical histories involving important organs.\n* 7\\. Participants with known active central nervous system (CNS) metastasis.\n* 8\\. Participants with any of the cardiovascular\u002Fcerebrovascular disorders, symptoms, or manifestations.\n* 9\\. Participants with the following conditions will be excluded at screening: active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), with the exception of asymptomatic chronic hepatitis B or C virus carriers.\n* 10\\. Participants with a history of interstitial pneumonia or other moderate to severe lung disorders that seriously affect lung function.\n* 11\\. Participants with severe infection during the screening period.\n* 12\\. Participants with other diseases that may affect the efficacy and safety of the study drug.\n* 13\\. Participants with uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites during the screening period.\n* 14\\. Participants with unstable thrombotic events requiring therapeutic intervention within 6 months before screening; however, thrombosis related to infusion devices is not included.\n* 15\\. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study period.\n* 16\\. Participants who have received strong CYP3A4 inhibitors and inducers therapy within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors and inducers during the study intervention and within 30 days after the last dose .\n* 17\\. Participants with history of solid organ transplant.\n* 18\\. Participants with known or suspected history of severe allergy to any component of the study drug or its analogues.\n* 19\\. Pregnant and lactating women.\n* 20\\. Participants who are deemed unsuitable for this study (e.g., poor compliance, etc.) by the investigator.",{"count":142,"type":21},63,[24],"The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:\n\n* Is the drug safe and tolerable ?\n* Does the drug exhibit antitumor activity ?\n\nParticipants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.",[146],"Advanced Solid Tumors",[148,149,150,151],"ADC","advanced solid tumors","EGFR","HER3","2026-04-13",{"date":154,"type":35},"2026-04-20",{"date":156,"type":21},"2026-04-10",{"date":158,"type":21},"2028-12-28",{"name":41,"class":42},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},"100633676","phase-1-study-to-assess-safety-and-efficacy-of-hdp-101-in-chinese-patients-with-relapsed-or-refractory-multiple-myeloma-100633676","NCT07529782","Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Life expectancy \\>12 weeks.\n* Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.\n* A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).\n* Must have undergone SCT or is considered transplant ineligible.\n* Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.\n* Measurable disease as per IMWG criteria (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).\n* Adequate organ system function as defined in protocol.\n\nExclusion Criteria:\n\n* Known central nervous system involvement.\n* Plasma cell leukemia.\n* History of congestive heart failure.\n* Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.\n* Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.\n* Radiotherapy within 21 days prior to the first study treatment infusion.\n* History of any other malignancy known to be active.\n* Known human immunodeficiency virus infection.\n* Patients with active infection requiring systemic anti-infective therapy.\n* Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.\n* Current active liver or biliary disease.\n* Pregnancy or breast feeding.\n* Pneumonia or symptomatic pneumonitis.",{"count":168,"type":21},15,[24],"This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and\u002For establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and\u002For RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r\u002Fr MM.",[172],"Multiple Myeloma and Other Plasma Cell Neoplasms",[174,175],"multiple myeloma","myeloma",{"date":177,"type":35},"2026-04-14",{"date":179,"type":35},"2026-03-17",{"date":181,"type":21},"2026-12-31",{"name":41,"class":42},5,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":66},"100633049","phase-2-efficacy-and-safety-of-hdm1005-compared-to-tirzepatide-in-obese-adults-without-diabetes-100633049","NCT07521631","Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes","A Phase 2, Randomized, Open-Label, Controlled Trial to Evaluate the Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes","Inclusion Criteria:\n\n1. The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender.\n2. BMI ≥28.0 but \\\u003C40.0 kg\u002Fm2 at screening and randomization\n3. Participants reported that they had been under diet and exercise control for 3 months or more before screening, and their weight change (the difference between the maximum body weight and the minimum body weight) in the past 3 months was less than 5%.\n4. fertile female subjects who have taken and agreed to continue to take effective contraceptive measures from 14 days before signing ICF to 60 days after the last dose, and have no plans to give birth and donate eggs; Male subjects signed ICF until 90 days after the last dose, had no fertility plan and sperm donation plan, and agreed to use highly effective contraception.\n\nExclusion Criteria:\n\n1. Previous diagnosis of type 1, type 2, or any other type of diabetes.\n2. History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type\n3. According to the investigator's judgment, the subjects have endocrine diseases or histories that affect gastric emptying, may significantly affect body weight, or diseases or conditions that affect the absorption of gastrointestinal nutrients, such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.\n4. Hypertension that was not stably controlled at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg (with stable treatment for at least 30 days if antihypertensive medications were used).\n\n   Have any malignant tumor within 5 years before signing ICF (except basal cell carcinoma which has received curative treatment and is regarded as cured).\n5. Those who had severe infection, severe trauma, or large or medium-sized surgery within 3 months before signing ICF, or planned to undergo surgery during the study (except outpatient surgery).\n6. Previous or combined presence or suspicion of depression or other psychiatric disorders or screening PHQ-9 score ≥15.\n7. Known intolerance or allergy to any component of the study drug or glucagon-like peptide-1 receptor (GLP-1R) agonist, or a previous history of severe drug allergy.\n8. Use of any of the following drugs, products, or treatments within 3 months prior to signing the ICF, including but not limited to:\n\n   A. a drug, product or treatment with weight loss effect b. Medications, products, or treatments that significantly increase body weight\n9. Use of hypoglycemic drugs within 3 months before signing ICF.\n10. Have participated in any clinical trial within 3 months before signing ICF or within 5 half-lives (whichever is longer) after the last dose of the investigational drug used in the clinical trial (except for those who signed ICF without drug or device intervention).\n11. History of addictive drug abuse within 1 year before signing ICF.\n12. Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C60 mL\u002Fmin\u002F1.73 m2;\n13. Those who donated blood or lost ≥400 mL of total blood within 3 months before signing ICF, or received blood transfusion or used blood products, or planned to donate blood during the study period.\n14. Pregnant or lactating women.","65 Years",{"count":193,"type":21},372,[77],"This is a 56-week randomized, open-label, controlled study evaluating the efficacy and safety of the HDM1005 compared to tirzepatide in adults with obesity but without diabetes. Eligible participants will be screened and randomized to different dose group of HDM1005 or the tirzepatide group at a ratio of 1:1:1 :1, HDM1005 or tirzepatide will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.",[197],"Obesity","2026-04-08",{"date":152,"type":35},{"date":201,"type":35},"2026-03-31",{"date":203,"type":21},"2027-07-23",{"name":41,"class":42},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":96,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":223,"locationsCount":66},"100631539","phase-1-influence-of-hdm1005-on-gastric-emptying-and-pharmacokinetics-of-metformin-atorvastatin-warfarin-and-digoxin-100631539","NCT07502001","Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin","A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight\u002FObese Adult Chinese Subjects","Inclusion Criteria:\n\n* Aged between 18 and 45 years (inclusive), regardless of gender.\n* Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight \\[kg\\]\u002Fheight² \\[m²\\]) within the range of 24.0 to 35.0 kg\u002Fm² (inclusive).\n* In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.\n* Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.\n\nExclusion Criteria:\n\n* Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).\n* History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n* History of an acute episode of cholecystitis within 3 months prior to screening.\n* Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.\n* Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.\n* Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).\n* Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).\n* Female participants who are breastfeeding or pregnant.\n* Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)",{"count":213,"type":21},42,[24],"The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight\u002Fobese adult subjects.",[124,197],"2026-03-24",{"date":219,"type":35},"2026-03-30",{"date":198,"type":21},{"date":222,"type":21},"2027-06-02",{"name":41,"class":42},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":66},"100625028","phase-3-a-study-of-hdm1005-in-participants-with-t2dm-not-controlled-with-metformin-alone-or-in-combination-with-a-sodium-glucose-cotransporter-2-sglt2-inhibitor-100625028","NCT07417306","A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor","A Multicenter, Randomized, Open-label, Parallel-controlled, Phase 3 Study to Compare the Efficacy and Safety of HDM1005 Versus Mazdutide in Subjects With T2DM Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor","Inclusion Criteria:\n\n1. Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and on a stable dosage of metformin alone or in combination with an SGLT2 inhibitor for at least 12 weeks prior to screening.\n2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) at randomization.\n3. Body Mass Index (BMI) ≥22.5 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Other types of diabetes besides T2DM.\n2. Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).\n3. History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF.\n4. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).\n5. History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.\n6. Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis.\n7. Use of antidiabetic medications within 12 weeks prior to signing the ICF, with the exception of metformin monotherapy or combination therapy with an SGLT2 inhibitor; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.\n8. Hemoglobin (Hb) \\\u003C100 g\u002FL (female) or \\\u003C110 g\u002FL (male).\n9. FPG ≥13.9 mmol\u002FL.\n10. Aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>3× ULN.\n11. Total bilirubin \\>1.5× ULN.\n12. Fasting triglyceride (TG) \\>5.6 mmol\u002FL (500 mg\u002FdL).",{"count":232,"type":21},912,[234],"PHASE3","This study is a multicenter, randomized, open-label, parallel-group, phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus active comparator in subjects with Type 2 Diabetes Mellitus (T2DM) Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor.\n\nA total of 912 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \\>8.5%) and metformin monotherapy (yes or no), then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (active comparator), with 304 subjects in each treatment group. All treatment groups will implement dose titration to achieve the target dose.\n\nThe study consists of: up to 2-week screening, 2-week run-in, 40-week core treatment, 12-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.",[237],"Type 2 Diabetes","2026-02-11",{"date":240,"type":35},"2026-02-18",{"date":242,"type":21},"2026-03-27",{"date":244,"type":21},"2027-12-31",{"name":41,"class":42},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":66},"100623244","phase-3-a-study-of-hdm1005-in-participants-with-type-2-diabetes-not-controlled-with-diet-and-exercise-alone-100623244","NCT07394114","A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone","A Multicenter, Randomized, Double-blind, Placebo-Controlled , Phase 3 Study Comparing the Efficacy and Safety of HDM1005 Versus Placebo in Subjects With T2DM Inadequate Glycemic Control With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and have not used any antihyperglycemic medications during for at least 12 weeks prior to screening.\n2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% at randomization.\n3. Body Mass Index (BMI) ≥22.5 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Other types of diabetes besides T2DM.\n2. Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketoticcoma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).\n3. History of a level 3 hypoglycemic episode or a history of asymptomatic hypoglycemic episodes within 24 weeks prior to signing the ICF.\n4. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).\n5. History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.\n6. Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis.\n7. Use of any antidiabetic medications within 12 weeks prior to signing the ICF; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.\n8. Hemoglobin (Hb) \\\u003C100 g\u002FL (female) or \\\u003C110 g\u002FL (male).\n9. FPG ≥13.9 mmol\u002FL.\n10. Aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>3× ULN.\n11. Total bilirubin \\>1.5× ULN.\n12. Fasting triglyceride (TG) \\>5.6 mmol\u002FL (500 mg\u002FdL).",{"count":254,"type":21},240,[234],"This study is a multicenter, randomized, double-blind, placebo-controlled , phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus placebo in subjects with T2DM inadequate glycemic control with diet and exercise alone.\n\nA total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \\>8.5%) , then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (placebo), with 80 subjects in each treatment group. At week 36, subjects in placebo group will receive HDM1005 injection until week 52. All treatment groups will implement dose titration to achieve the target dose.\n\nThe study consists of: up to 2-week screening, 2-week run-in, 36-week core treatment, 16-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.",[237],"2026-02-05",{"date":260,"type":35},"2026-02-09",{"date":262,"type":21},"2026-02-24",{"date":264,"type":21},"2027-12-17",{"name":41,"class":42},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":66},"100621974","phase-1-a-study-of-hdm2006-in-patients-with-advanced-solid-tumor-100621974","NCT07377591","A Study of HDM2006 in Patients With Advanced Solid Tumor","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of HDM2006 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. The subjects understand and voluntarily (or legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).\n\n  2\\. Males or females aged ≥ 18 years old. 3. In the dose escalation phase, subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment.\n\n  4\\. In the dose expansion phase, subjects must have histologically or cytologically confirmed advanced or metastatic specific types of tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment. These include, but are not limited to, head and neck squamous cell carcinoma, renal cell carcinoma, cervix carcinoma, and other advanced solid tumors, as well as tumor types that showed efficacy signals (CR\u002FPR) in the dose escalation phase.\n\n  5\\. In the dose expansion phase, subjects are able to provide fresh or archival (within one year) tumor tissues at the time of screening and are willing to provide tumor tissue biopsy after administration of HDM2006 for baseline and post-treatment biomarker analysis.\n\n  6\\. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 or 1 .\n\n  7\\. Expected survival time \\> 3 months. 8. According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), subjects in phase 1a must have at least one evaluable lesion, and subjects in phase 1b must have at least one measurable lesion (a lesion located in areas previously treated with radiotherapy will not be considered a measurable lesion unless there is sufficient evidence to show clear imaging progression of the lesion after radiotherapy; biopsy lesions should be excluded for measurable lesions in subjects in phase 1b).\n\n  9\\. The subject has good organ function as indicated by laboratory results at screening (no cytokine or other corrective medications are allowed within 14 days prior to laboratory tests at screening):Hematology: a) absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL (1500\u002Fmm3); b) platelet count ≥ 100 × 10\\^9\u002FL (no platelet transfusion within 14 days prior to the investigation); c) hemoglobin ≥ 9.0 g\u002FdL (no red blood cell transfusion within 30 days prior to the investigation); Liver: a) serum total bilirubin ≤ 1.5 × ULN; b) AST and ALT ≤ 3 × ULN (≤ 5 × ULN for subjects with tumor liver metastasis); c) serum albumin ≥ 30 g\u002FL (no albumin transfusion within 21 days prior to investigation); Kidney: blood creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula, see Appendix 4); Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, and the coagulation parameters \\[PT\u002FINR and APTT\\] are within the expected range for anticoagulant therapy at screening).\n\n  10\\. Women of childbearing potential (WOCBP) must be willing to use 2 adequate methods of contraception or barrier contraception plus hormonal contraception from the time of signing ICF until 6 months after the last dose of study treatment to prevent pregnancy or abstain from heterosexual activity throughout the study; male subjects must agree to take adequate contraceptive measures from the first dose of study treatment until 6 months after the last dose of study treatment .\n\n  11\\. Subject are willing and able to complete scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* 1\\. Subjects who are concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or they are in the survival follow-up period of an interventional study.\n\n  2\\. Subjects with the following treatments:\n  1. Subjects who have received major surgery within 4 weeks prior to the first dose, excluding minor surgery, such as appendicitis surgery, tissue acquisition for tumor biopsy, etc.;\n  2. Subjects who have received bone marrow (equivalent to pelvic bone marrow area) or extensive radiotherapy within 28 days prior to the first dose; subjects who have received local radiotherapy (e.g., thoracic and rib radiotherapy) within 7 days prior to the first dose of the study drug;\n  3. Subjects who have previously received HPK1 inhibitor treatment. 3. Subjects who have history of active malignancies within the past 2 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, cervix carcinoma in situ, breast cancer in situ, etc.\n\n     4\\. Subjects who have not recovered (i.e., recover to ≤ Grade 1 or baseline) from related AEs (such as alopecia, ≤ Grade 2 sensory neuropathy, or other ≤ Grade 2 AEs that do not pose a safety risk as judged by the investigator) resulting from previous treatments or other anti-tumor therapies.\n\n     5\\. Subjects with unstable brain metastasis: subjects with central nervous system complications requiring emergency neurosurgery (e.g., surgery) (excluding those who have completed surgery for more than 7 days and whose complications have resulted in ≤ Grade 1 side effects); 6. Subjects with epilepsy requiring treatment; subjects with a history of psychotropic drug abuse and unable to abstain or have mental disorders (those who have abstained must meet an observation period without withdrawal reactions for at least 2 weeks).\n\n     7\\. Subjects with any of the following cardiovascular diseases\u002Fsymptoms\u002Fsigns:\n\n  a) Mean QTc (corrected QT interval, calculated by Fridericia's formula) at rest: male \\> 450 ms, female \\> 470 ms, with the mean QTc of triplicate ECG measurements within ≥ 5 min (at least 1 min interval between two measurements, QT interval measurement should be from the beginning of the QRS complex to the end of the T wave); b) Any important abnormalities with clinically significant in rhythm, conduction, or morphology of the ECG at rest, such as complete left bundle branch block, 2nd and 3rd degree heart block, PR interval \\> 250 ms, etc.; c) Left ventricular ejection fraction (LVEF) \\\u003C 50%; 8. Immunodeficiency diseases (HIV) and active hepatitis (hepatitis B virus \\[HBV\\], hepatitis C virus \\[HCV\\]), excluding carriers with asymptomatic chronic HBV or HCV. Active HBV, HCV, and HIV positive infection is defined as: d) HBsAg is positive and HBV DNA is ≥ 2000 cps\u002FmL (or 500 IU\u002FmL); e) HCV antibody is positive and HCV RNA is higher than the upper limit of normal (ULN) of the study site; f) HIV antibody is positive. 9. Diagnosed interstitial lung disease with or without symptoms, as well as conditions that may cause drug-induced lung toxicity or related pneumonia, or pulmonary symptoms that the investigator considers unsuitable for inclusion or high-risk factors that may lead to interstitial lung disease and are not suitable for inclusion.\n\n  10\\. Subjects with other diseases that may affect the efficacy and safety of the study drug, including but not limited to:\n\n  a) Active infection requiring antibiotic therapy within 14 days prior to the start of study treatment; b) Active autoimmune disease or a history of autoimmune disease, including but not limited to inflammatory bowel disease, autoimmune hepatitis, Guillain-Barré syndrome, demyelinating disease, extensive dermatitis, immune-related interstitial pneumonia, or Grave's disease requiring drug medication; c) History of primary immunodeficiency; d) Active pulmonary tuberculosis; 11. A large amount or symptomatic moderate amount of pleural effusion, pericardial effusion, ascites at screening, and the symptoms are poorly controlled after treatment such as paracentesis and drainage.\n\n  12\\. Clinically significant gastrointestinal abnormalities or diseases at screening, resulting in great difficulties in drug intake, transport, or absorption (such as dysphagia, uncontrollable nausea and vomiting), etc.\n\n  13\\. History of solid organ transplant. 14. Known or suspected allergy to the study drug or its analogues. 15. Pregnant and lactating women. 16. The investigators consider that the subjects are not suitable to participate in this study (e.g., the treatment is not in the best interest of the subjects, the subjects have poor compliance, etc.).",{"count":274,"type":21},48,[24],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2006 in patients with advanced solid tumors.",[146],"2026-01-22",{"date":280,"type":35},"2026-01-30",{"date":282,"type":35},"2024-12-31",{"date":284,"type":21},"2027-03",{"name":41,"class":42},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":96,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":66},"100618420","phase-1-a-drug-drug-interaction-study-of-hdm1002-and-metformin-empagliflozin-midazolam-valsartan-and-warfarin-100618420","NCT07331389","A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin","A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight\u002FObese Adult Chinese Subjects","Inclusion Criteria:\n\n1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.\n2. Age range of 18-45 years old (including range), no limit to gender.\n3. Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg\u002Fm2 (including cut-off values).\n\nExclusion Criteria:\n\n1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng\u002FL during the screening period.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n3. History of acute cholecystitis attack within 3 months prior to screening.\n4. Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening\n5. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.\n6. Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, and active pathological bleeding, etc\n7. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.\n8. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .\n9. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.\n10. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.\n11. Presence of clinically significant ECG results judged by the investigator at screening.",{"count":294,"type":21},111,[24],"The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight\u002Fobese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated",[298,299],"Overweight Subject","Healthy Subjects",[301],"HDM1002","2025-12-30",{"date":304,"type":35},"2026-01-09",{"date":306,"type":35},"2025-09-24",{"date":308,"type":21},"2026-06-13",{"name":41,"class":42},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":66},"100614014","phase-1-a-phase-1-study-of-hdm2017-in-advanced-solid-tumors-100614014","NCT07274085","A Phase 1 Study of HDM2017 in Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Antitumor Efficacy of HDM2017 in Participants With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent.\n2. Male or female participants aged 18 to 75 years.\n3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors who have failed adequate standard of care, or are intolerant to standard of care, or have no effective standard treatment options.\n4. Be able to provide archived tumor tissue during the screening period.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Life expectancy ≥3 months.\n7. According to RECIST v1.1, participants must have at least one measurable lesion.\n8. Has adequate organ function.\n9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment.\n10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.\n2. Participants who have received the following treatments:\n\n   1. Participants who have undergone major surgery within 4 weeks before the first dose;\n   2. Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;\n   3. Participants receiving continuous systemic corticosteroid therapy;\n   4. Participants who have received systemic antitumor therapy, or any other investigational drug therapy within 4 weeks or 5 half-lives (whichever is shorter; at least 2 weeks) before the first dose.\n3. Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.\n5. Known weight loss of \\>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.\n6. History of gastrointestinal perforation, abdominal fistula, or extensive intestinal resection within 6 months before the first dose; complete or incomplete gastrointestinal obstruction or intra-abdominal abscess within 3 months before the first dose.\n7. History of gastrointestinal hemorrhage within 3 months before the first dose, or a clear gastrointestinal hemorrhagic diathesis.\n8. Participants with known active CNS metastasis.\n9. Participants with cardiovascular\u002Fcerebrovascular disorder, symptoms, or manifestations.\n10. Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.",{"count":318,"type":21},96,[24],"This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.",[322],"Solid Tumors","2025-12-09",{"date":325,"type":35},"2025-12-10",{"date":327,"type":35},"2025-11-18",{"date":329,"type":21},"2027-07-01",{"name":41,"class":42},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":66},"100614407","phase-3-efficacy-and-safety-of-hdm1005-in-chinese-obesity-or-overweight-patients-without-diabetes-100614407","NCT07279194","Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes","Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years at the time of signing informed consent.\n2. BMI≥28 kg\u002Fm2 or ≥24 kg\u002Fm2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.\n3. A self-reported change in body weight no more than 5% within 90 days before screening.\n4. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus (T1DM) or T2DM.\n2. Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol\u002FL at Visit 1.\n3. Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.\n4. Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R\u002FGCGR agonists or GIPR\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists within 3 months prior to screening.\n5. Use of hypoglycemic drugs within 3 months prior to screening.\n6. History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.\n7. Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.\n8. PHQ questionnaire ≥ 15 points at screening or randomization.\n9. Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.\n10. Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).\n11. History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.\n12. History of severe cardiovascular or cerebrovascular diseases within the past six months.\n13. History of alcohol and drug abuse at screening.\n14. The participant may be allergic to ingredients in the study drug or drugs of the same class.\n15. Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.\n16. The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.",{"count":339,"type":21},825,[234],"This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.",[343],"Obesity & Overweight","2025-11-30",{"date":346,"type":35},"2025-12-12",{"date":348,"type":35},"2025-10-14",{"date":350,"type":21},"2026-12-13",{"name":41,"class":42},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":66},"100611701","phase-4-efficacy-and-safety-of-the-metsglt-2iglp-1ra-in-patients-with-type-2-diabetes-with-poor-glycemic-control-100611701","NCT07244003","Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control","Efficacy and Safety of the Triple Combination Therapy of Met\u002FSGLT-2i\u002FGLP-1RA or Other Oral Antidiabetic Drugs in Patients With Type 2 Diabetes Exhibiting Poor Glycemic Control","MESSAGE","Inclusion Criteria:\n\n* Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female;\n* Body mass index (BMI) ≥20kg\u002Fm² ;\n* Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C \\>=7.5% and\\\u003C=11.0%);\n* Volunteer to participate in this study and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes or other special types of diabetes;\n* Patients with acute complications of ketoacidosis\u002Fhyperglycemic hyperosmolar state\u002Flactic acidosis within 6 months before screening\n* Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy\n* Those who received insulin treatment within the previous week\n* Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides \\> 5.7 mmol\u002FL during the screening period\n* Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 UNL, or total blood bilirubin (TBIL) \\> 2 UNL;\n* Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL\u002Fmin\u002F1.73m² or serum creatinine≥1.5 UNL;\n* Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period\n* Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs;\n* Those who have participated in other drug clinical trials within 3 months before screening; 21. Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.",{"count":361,"type":21},430,[363],"PHASE4","The main objective of this study is to compare the efficacy and safety of the triple combination therapy of Met\u002FSGLT-2i\u002FGLP-1RA or other oral antidiabetic drugs in patients with type 2 diabetes exhibiting poor glycemic control.",[366],"T2DM (Type 2 Diabetes Mellitus)","2025-11-21",{"date":369,"type":35},"2025-11-24",{"date":371,"type":35},"2025-03-29",{"date":373,"type":21},"2028-06-30",{"name":41,"class":42},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":66},"100601932","phase-4-ganagliflozin-on-the-progression-of-kidney-disease-in-subjects-with-type-2-diabetes-mellitus-and-chronic-kidney-disease-100601932","NCT07116928","Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease","A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease","GLOW-CKD","Inclusion Criteria:\n\n* Male or female individuals aged 18 years and above;\n* Meets the diagnostic criteria for T2DM;\n* Meets the diagnostic criteria for CKD, during the screening period（CKD-EPI Formula）: eGFR ≥ 30 to \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2, and UACR is ≥ 30 to \\\u003C 5000 mg\u002Fg; Or eGFR ≥ 60 to \\\u003C 90 mL\u002Fmin\u002F1.73m\\^2, and UACR is ≥ 300 to \\\u003C 5000 mg\u002Fg ;\n* HbA1c ≥ 6.5% to ≤ 12%;\n* If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes or other special types of diabetes;\n* A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);\n* History of kidney transplantation;\n* Blood potassium level \\> 5.5 mmol\u002FL during the screening period.\n* New York Heart Association (NYHA) classification of grade IV during the screening period;\n* Experienced ketoacidosis, myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), hospitalization due to heart failure, or hospitalization due to urinary tract infection or acute kidney injury within 12 weeks before the screening period;\n* Receiving ACEi and ARB in combination;\n* Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization;\n* Receiving drugs with immunosuppressive effects (such as cyclophosphamide, cyclosporine A, tacrolimus, etc.) or biological agents (rituximab, belimumab, etc.) during the 12 weeks before the screening period;\n* Receiving SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks before the screening, or have previously used SGLT-2 inhibitor drugs and discontinued due to poor efficacy.",{"count":384,"type":21},1244,[363],"This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks",[366,388],"CKD - Chronic Kidney Disease","2025-11-16",{"date":327,"type":35},{"date":344,"type":21},{"date":393,"type":21},"2031-12-30",{"name":41,"class":42},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":96,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":66},"100584191","phase-2-phase-ii-clinical-study-of-hdm1005-injection-in-obese-adults-without-diabetes-mellitus-100584191","NCT06886126","Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus","Phase II Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Obese Nondiabetic Adult Subjects","Inclusion Criteria:\n\n1\\. The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender.\n\nBMI ≥28.0 but \\\u003C40.0 kg\u002Fm2 at screening and randomization 3. Participants reported that they had been under diet and exercise control for 3 months or more before screening, and their weight change (the difference between the maximum body weight and the minimum body weight) in the past 3 months was less than 5%.\n\n(4) fertile female subjects who have taken and agreed to continue to take effective contraceptive measures from 14 days before signing ICF to 60 days after the last dose, and have no plans to give birth and donate eggs; Male subjects signed ICF until 90 days after the last dose, had no fertility plan and sperm donation plan, and agreed to use highly effective contraception.\n\nExclusion Criteria:\n\n1. Previous diagnosis of type 1, type 2, or any other type of diabetes.\n2. History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.\n3. According to the investigator's judgment, the subjects have endocrine diseases or histories that affect gastric emptying, may significantly affect body weight, or diseases or conditions that affect the absorption of gastrointestinal nutrients, such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.\n4. The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization:\n\n   1. Unstable angina pectoris;\n   2. cardiac insufficiency (New York Heart Association \\[NYHA\\] class III or IV);\n   3. Myocardial infarction;\n   4. Coronary artery bypass grafting or percutaneous coronary intervention;\n   5. Severe arrhythmias such as sick sinus syndrome, second or third degree atrioventricular block;\n   6. Cerebrovascular accidents, such as cerebral infarction, transient ischemic attack, etc.\n5. Hypertension that was not stably controlled at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg (with stable treatment for at least 30 days if antihypertensive medications were used).\n6. Have any malignant tumor within 5 years before signing ICF (except basal cell carcinoma which has received curative treatment and is regarded as cured).\n7. Those who had severe infection, severe trauma, or large or medium-sized surgery within 3 months before signing ICF, or planned to undergo surgery during the study (except outpatient surgery).\n8. Previous or combined presence or suspicion of depression or other psychiatric disorders or screening PHQ-9 score ≥15.\n9. Known intolerance or allergy to any component of the study drug or glucagon-like peptide-1 receptor (GLP-1R) agonist, or a previous history of severe drug allergy.\n10. Use of any of the following drugs, products, or treatments within 3 months prior to signing the ICF, including but not limited to:\n\n    A. a drug, product or treatment with weight loss effect b. Medications, products, or treatments that significantly increase body weight\n11. Use of hypoglycemic drugs within 3 months before signing ICF.\n12. Have participated in any clinical trial within 3 months before signing ICF or within 5 half-lives (whichever is longer) after the last dose of the investigational drug used in the clinical trial (except for those who signed ICF without drug or device intervention).\n13. History of addictive drug abuse within 1 year before signing ICF.\n14. Any laboratory test during the screening period met the following criteria:\n\n    1. Hemoglobin \\\u003C100 g\u002FL in women and \\\u003C110 g\u002FL in men;\n    2. alanine aminotransferase \\>2.5× upper limit of normal (ULN), or aspartate aminotransferase \\>2.5×ULN, or total bilirubin \\>1.5×ULN (Gilbert's syndrome subjects with direct bilirubin \\\u003CULN can participate in this study);\n    3. TG \\>5.6 mmol\u002FL;\n    4. HbA1c ≥6.5%, or fasting plasma glucose ≥7.0 mmol\u002FL or \\\u003C3.9 mmol\u002FL;\n    5. Calcitonin ≥50 ng\u002FL;\n    6. Thyroid stimulating hormone \\>6 mIU\u002FL or \\\u003C0.4 mIU\u002FL;\n    7. serum amylase or lipase \\>2.0×ULN;\n    8. Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C60 mL\u002Fmin\u002F1.73 m2;\n    9. Positive test results for active hepatitis B, active hepatitis C, or treponema pallidum antibodies at screening; Antibodies to the human immunodeficiency virus were not negative.\n15. Alcohol abuse within 1 year before signing the ICF (i.e. more than 14 standard units per week for men and 7 standard units per week for women, with 1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine).\n16. Those who donated blood or lost ≥400 mL of total blood within 3 months before signing ICF, or received blood transfusion or used blood products, or planned to donate blood during the study period.\n17. Pregnant or lactating women.",{"count":254,"type":21},[77],"It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HDM1005 injection in nondiabetic obese adults.",[197],"2025-09-25",{"date":408,"type":35},"2025-09-30",{"date":410,"type":35},"2025-02-07",{"date":344,"type":21},{"name":41,"class":42},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":66},"100607815","phase-3-study-to-evaluate-hdm1002-tablets-in-adults-with-type-2-diabetes-mellitus-100607815","NCT07193459","Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise Only","Inclusion Criteria:\n\n1. Male or female subjects between 18 and 75 years of age (inclusive).\n2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF.\n3. HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.\n4. Having a body mass index (BMI) of 22.5 to 40.0 kg\u002Fm2, inclusive.\n5. Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration.\n6. Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus\n2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing ICF.\n3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)\n4. History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)\n5. Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.\n6. Have had any of the following within 3 months prior to screening:\n\n   * Unstable angina；\n   * Heart failure (New York Heart Association, class III or IV);\n   * Myocardial infarction (MI)；\n   * Coronary artery bypass grafting or percutaneous coronary intervention；\n   * Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.)；\n   * Cerebrovascular accident\n7. Have a history of proliferative diabetic retinopathy and\u002For diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study.\n8. Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.\n9. Those who have used the following drugs within 14 days before randomization or within 5 half-lives (whichever is longer), or who need to use the following drugs for a long time during the trial, are excluded: strong or moderate inhibitors of cytochrome P450 enzyme (CYP) 3A4, strong inducers of CYP3A4, strong inhibitors of P-gp, strong inducers of P-gp, inhibitors of OATP1B1 or OATP1B3, or narrow therapeutic index drugs that are CYP2C8, CYP3A4, UGT1A1, P-gp, OATP1B1 or OATP1B3 substrates.\n10. Use of any glucose-lowering medication within 10 weeks prior to signing ICF, including but not limited to: α-glucosidase inhibitors (e.g., acarbose), thiazolidinediones, and dipeptidyl peptidase-4 inhibitors (DPP-4i) inhibitors, glucose kinase activators, sodium-glucose cotransporter-2 inhibitors (SGLT-2i) ,with the exception of short-term insulin therapy due to a concomitant illness, stress, or perioperative period (cumulative duration ≤ 14 days).\n11. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 3 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety\u002Ftolerability or lack of efficacy.\n12. Pregnancy or lactation.\n13. Subjects with a known hypersensitivity to GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies.\n14. Enrolled in or participated in any other clinical study of drugs or medical devices within 3 months (or within 5 half-lives, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product or medical devices).\n15. Any other condition considered by the investigator which is not suitable for participating in this study.",{"count":421,"type":21},360,[234],"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only",[237],[426,427,428],"Glucagon-Like Peptide-1 Receptor Agonists","HDM1002 tablet","type 2 diabetes","2025-09-18",{"date":406,"type":35},{"date":432,"type":35},"2025-08-12",{"date":434,"type":21},"2027-02-01",{"name":41,"class":42},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":66},"100601377","phase-2-a-study-of-hdm1005-in-participants-with-t2dm-not-controlled-with-dietexercise-or-metformin-100601377","NCT07109700","A Study of HDM1005 in Participants With T2DM Not Controlled With Diet\u002FExercise or Metformin","A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet\u002FExercise or Metformin Therapy","Inclusion Criteria:\n\n* Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks;\n* Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%\n* Body Mass Index (BMI within the range of 22.5 \\~ 40.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* Other types of diabetes besides T2DM\n* Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF)\n* History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF\n* History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)\n* History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease within 24 weeks prior to signing the ICF\n* Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis\n* Use of antidiabetic medications within 12 weeks prior to signing the ICF\n* Hemoglobin (Hb) \\\u003C100 g\u002FL (female) or \\\u003C110 g\u002FL (male)\n* FPG ≥13.9 mmol\u002FL\n* Aspartate aminotransferase (AST) \\>2.5× upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>2.5× ULN\n* Total bilirubin \\>1.5× ULN\n* Fasting triglyceride (TG) \\>5.6 mmol\u002FL (500 mg\u002FdL)",{"count":444,"type":21},216,[77],"This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet\u002Fexercise or metformin therapy.\n\nA total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \\>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5\u002F1.0\u002F2.0\u002F3.0mg), there will be \\~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration.\n\nThe study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.",[237],{"date":449,"type":35},"2025-08-17",{"date":451,"type":35},"2025-04-30",{"date":453,"type":21},"2026-02-28",{"name":41,"class":42},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"100602547","phase-1-a-study-of-hdm2005-in-combination-with-standard-of-care-in-patients-with-diffuse-large-b-cell-lymphoma-100602547","NCT07124936","A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","A Phase 1b\u002F2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Male or female aged 18-75 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Life expectancy \\>12 weeks.\n4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).\n\n   a. Cohort B: International Prognostic Index (IPI) score of 2-5.\n5. Prior treatment:\n\n   1. Cohort A: At least one (≥1) line of prior systemic therapy.\n   2. Cohort B: Has received no prior treatment for DLBCL.\n6. At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan.\n7. Adequate organ system and hematologic function as defined in protocol.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) lymphoma.\n2. Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.\n3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n4. History of severe bleeding disorders.\n5. History of interstitial lung disease or radiation pneumonitis.\n6. Prior solid organ transplant.\n7. Ongoing Grade \\>1 treatment-related adverse events.\n8. Current or history of clinically significant cardiovascular and cerebrovascular diseases.\n9. Active infection requiring systemic therapy.\n10. Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.\n11. Prior ROR1-targeted therapy.\n12. Ongoing corticosteroid therapy.\n13. Current active autoimmune disease or history of autoimmune disease requiring treatment.\n14. History of drug anaphylaxis or severe food allergy.\n15. Any history or current evidence of disease, treatment, or laboratory abnormality as determined by the investigator that may affect the study results, interfere with the subject's full participation in the study, or be contrary to the subject's best interests.",{"count":463,"type":21},97,[24,77],"The purpose of this phase 1b\u002F2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed\u002Frefractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The study will consist of two parts: dose-escalation part and dose-expansion part.",[467],"Diffuse Large B Cell Lymphoma (DLBCL)",[469],"DLBCL","2025-08-11",{"date":472,"type":35},"2025-08-15",{"date":474,"type":35},"2025-07-30",{"date":476,"type":21},"2029-10-25",{"name":41,"class":42},21,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":497,"locationsCount":66},"100600650","phase-1-a-study-of-hdm2012-in-patients-with-advanced-solid-tumor-100600650","NCT07100249","A Study of HDM2012 in Patients With Advanced Solid Tumor","A Phase Ia\u002FIb Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of HDM2012 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. The participants understand and voluntarily (or their legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).\n2. Males or females aged ≥18 years and less than or equal to 75 years.\n3. For escalation cohorts in the dose escalation phase: subjects must have histologically or cytologically confirmed advanced or metastatic malignant solid tumors, who have been previously treated and failed after adequate standard therapy, and have no standard treatment options available that have the potential to confer clinical benefit, including but not limited to gastric cancer (including esophagogastric junction adenocarcinoma), colorectal cancer, pancreatic cancer, etc.\n4. For backfill cohorts in the dose escalation phase and the dose expansion phase: subjects must have histologically or cytologically confirmed advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) or colorectal cancer.\n5. Tumor tissue samples must be sent to the central laboratory for immunohistochemical testing.\n6. ECOG performance status of 0 - 1.\n7. Expected survival time \\>3 months.\n8. Per RECIST v1.1 criteria: Ia phase subjects in dose escalation cohort must have at least one evaluable lesion; Ia phase subjects in backfill cohort and Ib phase subjects must have at least one measurable lesion (tumor lesions in previously irradiated areas are not considered measurable unless clear radiographic progression post-radiation is documented; measurable lesions in Ib phase should exclude biopsy sites).\n9. Adequate organ function demonstrated by screening laboratory tests (no growth factors or corrective treatments allowed within 14 days prior to screening tests).\n10. Willingness of women of reproductive potential to observe conventional and highly effective birth control methods with failure rates of \\\u003C1% for the duration of treatment and for 7 months following the last dose of study treatment; Willingness of men of reproductive potential to observe conventional and highly effective birth control methods with failure rates of \\\u003C1% for the duration of treatment and for 4 months following the last dose of study treatment; this must include barrier methods such as condom or diaphragm with spermicidal gel. Women of reproductive potential have a negative serum pregnancy test within 7 days before study enrollment; For male participants with a nonpregnant female partner of child-bearing potential and a woman of child-bearing potential, one of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended .\n11. Willing and able to complete scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors.\n2. Subjects who have received the following treatments:\n\n   1. Major surgery within 4 weeks prior to first dose, except minor procedures such as appendectomy, tumor biopsy, etc.;\n   2. Radiation therapy to bone marrow (equivalent to pelvic marrow area) or extensive radiation within 4 weeks prior to first dose; local radiotherapy (e.g., thoracic vertebrae and rib radiation) within 2 weeks prior to first dose;\n   3. Continuous systemic corticosteroid administration (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to first dose; low-dose corticosteroids (≤10 mg\u002Fday prednisone equivalent) are permitted if dose has been stable for 4 weeks;\n   4. Subjects who have received other systemic anti-tumor therapies within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose, unless a scientifically justified washout period is provided, such as relevant PK\u002FPD of the prior therapy and relevant clinical and laboratory parameters, based on the characteristics of preceding therapy.\n3. Active malignancies within past 2 years, except studied cancer and cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ).\n4. Subjects have not recovered from prior treatment-related or other anti-cancer therapy-related AEs (alopecia, ≤Grade 2 sensory neuropathy, or other ≤Grade 2 AEs deemed non-safety risks by investigator are acceptable) to ≤Grade 1 or baseline.\n5. Known active central nervous system metastases. Untreated asymptomatic or treated brain metastasis subjects with radiologically confirmed stable status for ≥4 weeks and no need for steroids\u002Fantiepileptics ≥2 weeks may be enrolled. Leptomeningeal metastases (symptomatic or asymptomatic) must be excluded.\n6. Subjects with any cardiovascular\u002Fcerebrovascular diseases\u002Fconditions\u002Findications.\n7. At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis (HBV, HCV), except for asymptomatic chronic hepatitis B or C carriers.\n8. History of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on chest computed tomography (CT) during screening; previous use of hormone shock therapy for pneumonia.\n9. Complete or incomplete intestinal obstruction or imaging findings indicating risk of intestinal obstruction.\n10. Presence of other diseases that may affect the efficacy and safety of the IMP.\n11. Presence of large or symptomatic moderate pleural effusion, pericardial effusion, or ascites during screening that remains poorly controlled despite treatments like drainage.\n12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, and pulmonary embolism; excluding catheter-related thrombosis.\n13. Previous solid organ transplantation.\n14. Known or suspected allergy to IMP components or their analogs.\n15. Pregnant or breastfeeding women.\n16. Investigator's judgment that the subject is unsuitable for participation (e.g., non-optimal treatment benefit, poor compliance, etc.).\n17. Received strong or moderate CYP3A4 inhibitors or inducers within 1 week prior to dosing or 5 half-lives (whichever is longer), or anticipated need for long-term use of strong or moderate CYP3A4 inhibitors or inducers during study intervention and within 30 days after last dose.",{"count":487,"type":21},129,[24],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2012 in patients with advanced solid tumors.",[146],"2025-08-06",{"date":493,"type":35},"2025-08-08",{"date":491,"type":35},{"date":496,"type":21},"2028-06",{"name":41,"class":42},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":144,"conditions":508,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":66},"100600481","phase-1-a-study-of-hdm2020-in-patients-with-advanced-solid-tumors-100600481","NCT07098052","A Study of HDM2020 in Patients With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of HDM2020 (FGFR2b-ADC) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants who understand and voluntarily (or legal guardian) sign a written ICF approved by the Institutional Review Board or Independent Ethics Committee.\n2. Male or female participants aged ≥18 years.\n3. Participants must be patients with advanced or metastatic malignant solid tumors confirmed by histology or cytology, and have experienced sufficient standard treatment failure, or are intolerant to standard treatment, or have no effective standard treatment.\n4. Tumor tissue samples are required to be sent to the central laboratory for IHC testing.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.\n6. The expected survival time is \\>3 months.\n7. According to the RECIST v1.1, participants in Phase Ia must have at least one evaluable lesion, and participants in Phases Ib must have at least one measurable lesion.\n8. Laboratory test results during the screening period indicate that the participants have good organ function.\n9. Women of childbearing potential (WOCBP) must be willing to use two appropriate barrier methods of contraception from the time of signing informed consent until 7 months after the last dose of study treatment or use barrier contraception plus hormonal contraception to prevent pregnancy, or abstain from heterosexual intercourse throughout the study period; male participants must agree to take adequate contraceptive measures from the first dose of study treatment until 7 months after the last dose of study treatment.\n10. Participants with the willingness and ability to complete regular visits, treatment plans, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Participants with prior treatment with an ADC containing a topoisomerase I (Top I) inhibitor.\n2. Participants with active or chronic corneal disorders, history of corneal transplant, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulcer, other active eye disorders, and any clinically significant corneal disorders.\n3. Participants underwent major surgery within 4 weeks before the first dose; Participants received bone marrow or extensive radiotherapy within 4 weeks before the first dose; received local radiotherapy within 2 weeks before the first dose of the study drug; Participants continuously received systemic corticosteroids; Participants received standard chemotherapy, biological therapy, immunotherapies, any investigational medicinal product (IMP) and other systemic anti-tumor treatments within 4 weeks before the first dose.\n4. Participants with active malignant tumors within the past 2 years.\n5. Participants not recovered (recovered to ≤ Grade 1 or baseline) from relevant AEs resulting from prior treatments or other anti-cancer therapies.\n6. Participants with known active central nervous system (CNS) metastases.\n7. Participants with any of the following cardiovascular\u002Fcerebrovascular diseases\u002Fsymptoms\u002Findications: a) Mean resting QTc : ≥470 ms, ECG QTc measured three times within 10 min as the mean value; or those have a history or family history of congenital long QT syndrome; b) Any clinically significant abnormalities in resting ECG in rhythm, conduction, or morphology; c) Left ventricular ejection fraction (LVEF) \\\u003C50%; d) Participants with a history of myocardial contraction decreased and exhibited related symptoms within 6 months before study drug administration; e) Hypertension uncontrolled by drug therapy\n8. At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV).\n9. Presence of interstitial pneumonia, history of idiopathic pulmonary fibrosis, history of organising pneumonia, history of drug-induced pneumonia, history of idiopathic pneumonia, or evidence of active pneumonia found on chest computed tomography (CT) scan during the screening period; prior use of steroid pulse therapy due to pneumonia; Moderate or severe chronic obstructive pulmonary disease (COPD); Pulmonary malignant lymphangitis.\n10. Other diseases that may affect the efficacy and safety of the study drug, including but not limited to: a) Active infection requiring antibiotic therapy occurring within 2 weeks prior to the administration of study drug; b) Active autoimmune diseases or a history of autoimmune diseases; c) History of primary immunodeficiency; d) Active pulmonary tuberculosis; e) Participants who have had a clinically significant haemorrhage or significant haemorrhagic diathesis within 4 weeks before signing the informed consent; f) Any severe or uncontrolled systemic disease.\n11. Large amounts or symptomatic moderate amounts of pleural effusion, pericardial effusion, or ascites during the screening period, and still poorly controlled after treatments.\n12. Unstable thrombosis events requiring therapeutic intervention within 6 months before screening.\n13. A history of solid organ transplant.\n14. Known or suspected hypersensitivity to the study drug or its analogues.\n15. Pregnant and breastfeeding women.\n16. The investigator considers that the participant is not suitable to participate in this study.\n17. Participants who have received strong CYP3A4 inhibitors within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors during the study intervention period and within 30 days after the last dose.",{"count":506,"type":21},60,[24],[509],"Solid Tumor","2025-07-24",{"date":512,"type":35},"2025-08-01",{"date":470,"type":21},{"date":515,"type":21},"2027-05-30",{"name":41,"class":42},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":66},"100599255","phase-3-a-phase-3-study-to-evaluate-efficacy-and-safety-of-hdm1002-tablets-in-adults-with-type-2-diabetes-mellitus-100599255","NCT07082114","A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus","A Phase 3, Randomized, Double-blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets Compared With Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin","Inclusion Criteria:\n\n1. Male or female subjects between 18 and 75 years of age (inclusive).\n2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and participants treated with a stable dose of metformin (with maintenance dose of at least 1500 mg\u002Fday or a maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.\n3. HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤11.0% prior to randomization as assessed by the specified central laboratory.\n4. Having a body mass index (BMI) of 19.0 to 40.0 kg\u002Fm2, inclusive.\n5. Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration.\n6. Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus\n2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing the informed consent form (ICF).\n3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)\n4. History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)\n5. Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.\n6. Have had any of the following within 3 months prior to screening:\n\n   * Unstable angina；\n   * Heart failure (New York Heart Association, class III or IV);\n   * Myocardial infarction (MI)；\n   * Coronary artery bypass grafting or percutaneous coronary intervention；\n   * Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.)；\n   * Cerebrovascular accident\n7. Have a history of proliferative diabetic retinopathy and\u002For diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study.\n8. Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.\n9. Used strong CYP3A4 or P-gp inhibitors within 14 days prior to randomization or 5 half-lives (whichever is longer); current use with strong\u002Fmoderate CYP3A4 inhibitors or strong P-gp inducers that cannot be discontinued during the trial; any prior use OATP1B1\u002FOATP1B3 inhibitors; current use with narrow therapeutic index drugs that are substrates of CYP2C8, CYP3A4, UGT1A1, P-gp, or OATP1B1\u002FOATP1B3 and cannot be discontinued during the trial.\n10. Use of any glucose-lowering medication within 4 weeks prior to signing the ICF, including but not limited to: α-glucosidase inhibitors (e.g., acarbose), thiazolidinediones, and dipeptidyl peptidase-4 inhibitors (DPP-4i) inhibitors, glucose kinase activators, sodium-glucose cotransporter-2 inhibitors (SGLT-2i) ,with the exception of short-term insulin therapy due to a concomitant illness, stress, or perioperative period (cumulative duration ≤ 7 days).\n11. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 3 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety\u002Ftolerability or lack of efficacy.\n12. Pregnancy or lactation.\n13. Subjects with a known hypersensitivity to SGLT-2i or GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies.\n14. Enrolled in or participated in any other clinical study of drugs or medical devices within 3 months (or within 5 half-lives, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product or medical devices).\n15. Any other condition considered by the investigator which is not suitable for participating in this study.",{"count":525,"type":21},800,[234],"This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.",[237],[426,427,428],"2025-07-23",{"date":510,"type":35},{"date":533,"type":35},"2025-07-14",{"date":535,"type":21},"2027-05-17",{"name":41,"class":42},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":66},"100595724","phase-3-efficacy-and-safety-of-semaglutide-injection-vs-wegovy-in-chinese-obese-patients-100595724","NCT07036172","Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients","A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent；\n2. BMI ≥28 kg\u002Fm2；\n3. A self-reported change in body weight no more than 5% within 90 days before screening.\n\nExclusion Criteria:\n\n1. History of type 1 and type 2 diabetes;\n2. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;\n3. History or presence of chronic or acute pancreatitis;\n4. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;\n5. A history or presence of suspected depression or other mental disorders;\n6. Patient Health Questionnaire-9 score of ≥15 at screening\n7. Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening;\n8. History of malignant neoplasms within the past 5 years prior to screening;",{"count":545,"type":21},460,[234],"This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.",[549],"Obesity Control","2025-06-16",{"date":552,"type":35},"2025-06-25",{"date":554,"type":35},"2025-01-03",{"date":556,"type":21},"2026-05",{"name":41,"class":42},""]