[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gan & Lee Pharmaceuticals.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":363},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,65,86,107,128,151,172,192,214,235,256,276,296,315,337],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100633468","phase-3-evaluate-the-efficacy-and-safety-of-gzr33-injection-in-patients-with-type-2-diabetes-100633468",false,"NCT07527078","Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes","A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Comparing the Efficacy and Safety of GZR33 Injection and Insulin Degludec Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antidiabetic Drugs","Inclusion Criteria:\n\n1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.\n2. Male or female, aged ≥18 years at the time of informed consent..\n3. Body mass index (BMI) ≥18.5 and ≤35.0 kg\u002Fm2 at screening.\n4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.\n5. Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to ≥ 2 drugs with distinct mechanisms of action, or known hypersensitivity, allergic reactions, or intolerance to the investigational medicinal products or their excipients (glycerol, phenol, metacresol, zinc acetate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide).\n2. Female subjects who are pregnant, lactating at screening, or planning a pregnancy during the trial period.\n3. Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes syndrome, cystic fibrosis-related diabetes, pancreatitis-induced diabetes, drug- or chemical-induced diabetes, etc.) prior to screening.\n4. Presence of any diseases that may affect HbA1c testing at screening, such as hemolytic anemia, aplastic anemia, hemoglobinopathy, etc., and in the investigator's judgment unsuitable for participation; or blood donation, blood loss \\> 400 mL, or blood transfusion within 90 days prior to screening.\n5. History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening.\n6. Significant hepatic or renal dysfunction or active infectious diseases at screening.\n7. Lifestyle (diet, exercise, work circadian rhythm, etc.) expected to change significantly during the trial and affect glycemic control; irregular three-meal intake (e.g., habitual skipping of breakfast); or unwillingness to comply with relevant lifestyle restrictions during the trial.\n8. Any other conditions that, in the investigator's judgment, may compromise subject safety or interfere with trial conduct, progress, or outcome.","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.",[26],"Type 2 Diabetes (T2DM)","RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":31},"2026-04-07",{"date":35,"type":20},"2027-04-17",{"name":37,"class":38},"Gan & Lee Pharmaceuticals.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":39},"100644609","phase-1-bioequivalence-study-of-gzr4-injection-with-different-manufacturing-processes-in-healthy-adult-participants-100644609","NCT07670897","Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants","A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants","Inclusion Criteria:\n\n* 1\\. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.\n\n  2\\. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg\u002Fm² (inclusive) at screening.\n\n  4\\. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.\n\nExclusion Criteria:\n\n* 1\\. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.\n\n  2\\. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.\n\n  3\\. Have special dietary requirements and are unable to comply with the standardized diet.\n\n  4\\. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.\n\n  5\\. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him\u002Fher unsuitable for participation in the study.",true,"MALE","50 Years",{"count":51,"type":20},64,[53],"PHASE1","This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.",[56],"T2D","NOT_YET_RECRUITING","2026-06-22",{"date":60,"type":31},"2026-06-26",{"date":30,"type":20},{"date":63,"type":20},"2026-07-29",{"name":37,"class":38},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":39},"100622698","phase-2-evaluate-the-efficacy-and-safety-of-gzr101-80-injection-in-patients-with-type-2-diabetes-100622698","NCT07387003","Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes","A Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin","Inclusion Criteria:\n\n1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.\n2. At the age of 18-75 (inclusive) at the time of informed consent, male or female.\n3. Body mass index (BMI) ≥18.5 and ≤35.0 kg\u002Fm2 at screening.\n4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.\n\nExclusion Criteria:\n\n1. Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.\n2. Grade 3 hypoglycemia within 3 months before screening.\n3. Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.\n4. Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor at screening.","75 Years",{"count":74,"type":20},345,[76],"PHASE2","This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.",[26],"2026-04-10",{"date":81,"type":31},"2026-04-15",{"date":79,"type":20},{"date":84,"type":20},"2027-09-23",{"name":37,"class":38},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":39},"100631526","phase-3-evaluate-the-efficacy-and-safety-of-gzr18-injection-in-obese-subjects-with-obstructive-sleep-apnea-receiving-positive-airway-pressure-pap-therapy-100631526","NCT07501832","Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy","A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy","Inclusion Criteria:\n\n1. Subject is aged ≥18 years at the time of signing the informed consent form.\n2. Body mass index (BMI) is ≥28 kg\u002Fm² at both screening and randomization.\n3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had \\\u003C5% change in body weight during the 12 weeks prior to screening (see Appendix 2 for the weight change calculation formula).\n4. Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events\u002Fhour on polysomnography (PSG) at screening. (See Appendix 3 for ICSD-3 diagnostic criteria for adult OSA.)\n5. Subject has been receiving continuous positive airway pressure (PAP) therapy for at least 12 consecutive weeks prior to screening and intends to continue PAP therapy throughout the study period.\n6. Subjects of childbearing potential must agree to remain abstinent or use highly effective contraception from the time of signing informed consent until 8 weeks after the last dose of investigational product, and must not donate sperm or oocytes during this period. Female subjects of childbearing potential must not be lactating and must have a negative pregnancy test at both screening and randomization.\n7. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial; is able to communicate effectively with the investigator; comprehends and agrees to comply with all study requirements; and voluntarily signs the informed consent form to participate in this study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.\n2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).\n3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed \\>1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed \\>1 year before screening).\n4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic\u002Fpituitary injury).\n5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.\n6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.\n7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.\n8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.\n9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).\n10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures\u002Ftherapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)\n11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the \"Suicidal Ideation\" section, or any question in the \"Suicidal Behavior\" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.\n12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.\n13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).\n14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.\n15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal\u002Fsquamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).",{"count":94,"type":20},140,[23],"The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.",[98],"Obstructive Sleep Apnea (OSA)","2026-03-30",{"date":101,"type":31},"2026-04-03",{"date":103,"type":20},"2026-03-27",{"date":105,"type":20},"2028-09-28",{"name":37,"class":38},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":39},"100630852","phase-3-evaluate-the-efficacy-and-safety-of-gzr18-injection-in-obese-subjects-with-obstructive-sleep-apnea-not-treated-with-positive-airway-pressure-pap-therapy-100630852","NCT07493057","Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy","A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）","Inclusion Criteria:\n\n1. Subject is aged ≥18 years at the time of signing the informed consent form.\n2. Body mass index (BMI) is ≥28 kg\u002Fm² at both screening and randomization.\n3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had \\\u003C5% change in body weight during the 12 weeks prior to screening.\n4. Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events\u002Fhour on polysomnography (PSG) at screening.\n5. Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.\n2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).\n3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed \\>1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed \\>1 year before screening).\n4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic\u002Fpituitary injury).\n5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.\n6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.\n7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.\n8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.\n9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).\n10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures\u002Ftherapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)\n11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the \"Suicidal Ideation\" section, or any question in the \"Suicidal Behavior\" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.\n12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.\n13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).\n14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.\n15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal\u002Fsquamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).",{"count":94,"type":20},[23],"This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.",[98],[119,120],"obesity","obstructive sleep apnea","2026-03-24",{"date":103,"type":31},{"date":124,"type":20},"2026-04-27",{"date":126,"type":20},"2027-11-14",{"name":37,"class":38},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100615425","phase-3-extension-study-of-the-phase-3-clinical-study-of-gzr18-injection-for-weight-loss-100615425","NCT07292441","Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss","A Multicenter Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss","GZR18-BWM-303","Inclusion Criteria:\n\n1. Subjects who participated in the original study, completed the last dose at W50, EOT visit at W52 and safety follow-up visit at W55 of either original study, with last dose at W50 ≥ 24 mg (including blinded dose of placebo).\n2. Subjects with BMI \\> 18.5 kg\u002Fm² at W55 of the original study and before randomization at Visit 2 (V2) of this study, who are assessed by the investigator as suitable for participating in this study.\n3. Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Non-lactating women of childbearing potential (WOCBP) with a negative pregnancy test result before randomization at V2 in this study.\n4. Able to understand the procedures and methods of this study, willing and able to maintain a regular diet and exercise lifestyle during the study period, willing and able to undergo subcutaneous injections of the investigational medicinal product (IMP), and willing to sign the ICF voluntarily.\n\n   \\-\n\nExclusion Criteria:\n\n1. Subjects who used Semaglutide (Wegovy®) in the original study.\n2. Subjects with a previous diagnosis of any type of diabetes mellitus (excluding gestational diabetes mellitus).\n3. Subjects with FPG ≥ 7.0 mmol\u002FL or HbA1c ≥ 6.5% in the central laboratory test at W52 visit of the original study.\n4. Subjects who plan to participate in another clinical study of an investigational medicinal product or device, or receive drug or non-drug therapies that affect body weight (excluding diet and exercise control) before completing all scheduled assessments in this clinical study.\n5. Subjects with any other factors (including but not limited to previous compliance in the original study) that may affect the efficacy or safety evaluation of this study as judged by the investigator.\n\n   \\-",{"count":137,"type":20},500,[23],"This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18 Injection once every 4 weeks (Q4W) for 24 weeks on body weight.\n\nIn this study, it is planned to include subjects who have participated in the original study and completed the study contents of the original protocol. All subjects will maintain a regular diet and exercise lifestyle during the study.",[141],"Overweight or Obesity","2026-03-10",{"date":144,"type":31},"2026-03-11",{"date":146,"type":31},"2026-01-22",{"date":148,"type":20},"2027-10",{"name":37,"class":38},2,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":39},"100628957","phase-1-a-phase-i-clinical-study-of-glr2037-in-patients-with-advanced-prostate-cancer-100628957","NCT07468396","A Phase I Clinical Study of GLR2037 in Patients With Advanced Prostate Cancer","A Phase I, Single-arm, Open-label, Multi-center Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GLR2037 in Patients With Metastatic Prostate Cancer","Inclusion criteria:\n\n1. Male, aged ≥ 18 years.\n2. Histologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell features.\n3. Metastatic bone or soft tissue lesions documented by imaging.\n4. Prior surgical or medical castration.\n5. Castrate level of testosterone at screening (≤ 50 ng\u002FdL or 1.73 nmol\u002FL).\n6. Phase Ia and Ib: Prior treatment with at least one novel endocrine therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide, rezlutamide, etc.); patients in the dose-escalation phase of Phase Ia must have received at least one prior line of chemotherapy (e.g., docetaxel, cabazitaxel, etc.).\n7. Evidence of disease progression during castration therapy in patients with metastatic prostate cancer at screening.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n9. Adequate organ function meeting protocol-specified criteria.\n10. Life expectancy ≥ 3 months.\n11. Fertile male subjects and their partners must agree to use effective contraception (e.g., condoms) and refrain from donating sperm from the first dose of the study drug until 3 months after the last dose.\n12. Willing to participate in this clinical trial, understand the study procedures, and have signed the informed consent form.\n\nExclusion Criteria:\"1. Prior use of AR protein degraders. 2. Use of any other biological and\u002For immunological anti-tumor therapy (except castration therapy), targeted therapy, estrogen therapy, anti-androgen therapy, or other interventional investigational drug therapy; or receipt of systemic chemotherapy, systemic radiotherapy, or Chinese herbal\u002Fpatent medicine with anti-tumor indications (as clearly stated in the package insert) within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or receipt of nitrosoureas, bicalutamide, or nilutamide within 6 weeks (or 5 half-lives, whichever is shorter) prior to the first dose.\n\n3\\. Subjects who have used bisphosphonates or RANKL inhibitors for the treatment of bone metastases or bone-related diseases within 2 weeks prior to the first dose.\n\n4\\. Have received systemic immunosuppressive therapy within 2 weeks prior to the first dose.\n\n5\\. Use of strong inhibitors or inducers of CYP2C9 or CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to the first dose.\n\n6\\. Patients with imaging evidence of brain or central nervous system metastases.\n\n7\\. Severe bone injury caused by bone metastases of prostate cancer as judged by the investigator.\n\n8\\. Concurrent uncontrolled hypertension at screening. 9. Presence of active cardiac disease or occurrence of arterial or venous thromboembolism within 6 months prior to the first dose.\n\n10\\. History of other malignancies within 5 years prior to the first dose. 11. Have active hepatitis B (HBsAg positive and HBV-DNA titer ≥ 1×10³ copies\u002FmL), hepatitis C (HCV antibody positive); or severe infections requiring antibiotics, antiviral or antifungal drugs for control.\n\n12.History of immunodeficiency or organ transplantation. 13.Concurrent dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug administration and absorption.\n\n14.Not recovered from adverse events of prior anti-tumor therapy to ≤ Grade 1 at screening.\n\n15.Known allergy to any component or excipient of GLR2037. 16.Subjects who have received palliative radiotherapy or major surgery (Grade 3-4) within 4 weeks prior to the first dose, or have participated in other drug clinical trials within 4 weeks prior to the first dose.\n\n17.Plan to receive any other anti-tumor therapy during the study treatment period other than those specified in the protocol.\n\n18.Any concomitant disease or other condition that, in the judgment of the investigator, poses a serious risk to the safety of the subject or could affect the subject's completion of the study. \"",{"count":159,"type":20},65,[53],"A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer",[163],"Prostate Cancer","2026-03-09",{"date":166,"type":31},"2026-03-12",{"date":168,"type":20},"2026-04-30",{"date":170,"type":20},"2033-04-30",{"name":37,"class":38},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":47,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":39},"100620293","phase-1-bioequivalence-study-of-gzr18-injection-before-and-after-cmc-change-100620293","NCT07355738","Bioequivalence Study of GZR18 Injection Before and After CMC Change","A Randomized, Open-label, Single-dose, Parallel Comparison Study to Evaluate the Bioequivalence of GZR18 Injection Before and After CMC Change in Healthy Adult Male Subjects","Inclusion Criteria:\n\n1. Subjects who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.\n2. Male, 18 to 50 years of age at signing the ICF (both inclusive).\n3. Weight ≥ 50 kg and body mass index (BMI) within 19-26 kg\u002Fm2 (inclusive) at screening.\n4. Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation.\n\n   \\-\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities detected during the screening period in physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray, as determined by the investigator.\n2. Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody, P24 antigen, or anti-treponema pallidum antibody.\n3. Subjects with a history of or existing circulatory, urinary, digestive, respiratory, nervous, endocrine, or psychiatric disorders that, in the investigator's judgment, remain clinically significant.\n4. History of acute or chronic pancreatitis and pancreatic injury before screening.\n5. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.\n6. Subjects who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or subjects with acute diseases or concomitant medication from the screening period to before randomization.\n7. Subjects with severe infection or unexplained infection within 4 weeks before screening.\n8. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.\n9. Subjects known or suspected to have hypersensitivity to any ingredient of the investigational medicinal product (IMP) (glucagon like peptide-1 receptor agonist (GLP-1RA) or its excipients).\n10. Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicine within 2 weeks prior to screening; use of any GLP-1R agonists or drugs with the same mechanism of action to GLP-1R agonists (such as GLP-1R\u002Fglucagon receptor \\[GCGR\\] agonists or gastric inhibitory polypeptide receptor \\[GIPR\\]\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists) within 3 months prior to screening.\n11. Subjects who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study.\n12. Blood donation or blood loss greater than or equal to 400 mL within 3 months before screening, or blood donation scheduled during the study or within 8 weeks after the end of the study.\n13. History of drug abuse prior to screening; or positive results for drug abuse at screening (D-1).\n14. History of alcohol abuse within 3 months prior to screening, defined as an average intake of more than 14 units per week (1 standard unit=360 mL of beer or 150 mL of 12% wine or 45 mL of 40% spirits); or use of any alcohol-containing products 48 hours before administration; or abnormal results for breath alcohol test at screening (D-1).\n15. Subjects who smoked more than 5 cigarettes per day on average within the 3 months before screening, or who do not agree to abstain from smoking for the duration of the study.\n16. Subjects who engage in strenuous exercise within 48 h before administration of the IMP, or have other factors that may affect drug absorption, distribution, metabolism, or excretion.\n17. Subjects who consume grapefruit or grapefruit-containing products, or any caffeinated or xanthine-containing foods or beverages (such as coffee, tea, cola, or chocolate) within 48 hours before administration of the IMP.\n18. Subjects who have special dietary requirements and cannot adhere to a standardized diet, or who are lactose intolerant.\n19. Subjects with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venous blood collection.\n20. Subjects who are investigators or employees of the study site, or family members of the employees or investigators.\n21. Participation in a clinical study of another IMP or device within 3 months before screening, or within 5 half-lives of the previous IMP (whichever is longer). Or plan to participate in another clinical study of an IMP or device before completing all scheduled assessments in the clinical study.\n\n    \\-",{"count":180,"type":20},138,[53],"This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.\n\nThe study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes.\n\nSubjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject will receive a single dose of GZR18 Injection, followed by PK blood sampling and safety follow-up for 35 days. Subjects will be admitted to the hospital 1 day predose, follow a standardized light diet that evening, and then fast for at least 10 h thereafter. On the day of administration, GZR18 Injection of a single strength will be administered subcutaneously under fasting conditions at a site approximately two finger-widths (2.5 cm) away from the umbilicus on the abdomen. Lunch and dinner will be served approximately 3 and 9 h postdose, respectively.\n\nVenous blood will be collected at 14 time points for GZR18 plasma concentration analysis: at 0 h (within 60 min predose) and 1, 6, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, and 840 h postdose.\n\nSubjects will undergo corresponding laboratory safety tests at screening, D36, and early withdrawal visits.\n\nDuring the entire study period, subjects should maintain a light diet, avoid strenuous exercise, and refrain from consuming juice, caffeinated beverages (such as tea and coffee), and alcoholic drinks. Smoking and any other activities that may affect PK observation or safety evaluations are strictly prohibited.",[184],"Obesity&T2D","2026-01-21",{"date":146,"type":31},{"date":188,"type":31},"2026-01-09",{"date":190,"type":20},"2026-05-20",{"name":37,"class":38},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":47,"sex":48,"minAge":17,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":39},"100618659","phase-1-a-study-to-evaluate-the-biosimilarity-of-glr1044-injection-and-dupilumab-injection-dupixent-in-healthy-adult-male-subjects-100618659","NCT07334496","A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects","A Randomized, Double-blind, Single-dose, Parallel Comparison Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Chinese Adult Male Subjects","Inclusion Criteria:\n\n* 1.Voluntarily sign the informed consent form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.\n\n  2\\. Male subjects aged 18 to 55 years (both inclusive) at the time of signing informed consent forms.\n\n  3\\. Subjects must agree to use reliable contraception for themselves and their partners during the study and within 6 months after the end of the study (the contraception used should comply with local regulations on the use of contraceptive methods for subjects participating in clinical studies), and not donate sperm for assisted reproductive purposes.\n\n  4\\. The body mass index (BMI) at screening is 19-26 kg\u002Fm2 (both exclusive), and the weight is 55-85 kg (both exclusive).\n\n  5\\. The results of medical history review, physical examinations, laboratory tests, imaging examinations and ECG at screening\u002Fvisit 2 (V2) are judged by the investigator to be normal or abnormal but not clinically significant.\n\nNo personal history of tuberculosis, no possible previous history of tuberculosis exposure, and no previous and\u002For current immunomodulatory treatment.\n\n6.No personal history of tuberculosis, no possible previous history of tuberculosis exposure, and no previous and\u002For current immunomodulatory treatment.\n\nExclusion Criteria:\n\n* 1.History of drug abuse within 1 year prior to screening, or positive predose drug abuse screening result at Visit 2 (V2); or history of alcohol abuse within 6 months prior to screening, or positive predose alcohol breath test result at V2.\n\n  2\\. Subjects who smoked \\> 5 cigarettes\u002Fday within 3 months prior to screening or who cannot stop using any tobacco products during the study.\n\n  3\\. The subject and\u002For first-degree relatives have a history of venous thromboembolic events or idiopathic venous thromboembolic events before screening.\n\n  4\\. Presence of sunburn, scar tissue, tattoos, open ulcers or branding at screening that the investigator believes will interfere with the interpretation of adverse skin reactions.\n\n  5\\. Eye or oral infections at screening, including but not limited to conjunctivitis, blepharitis and oral herpes.\n\n  6\\. The following medical history with a clear diagnosis in the past or at screening: Subjects with cardiovascular disorders, hematological diseases, respiratory disorders, digestive system diseases, abnormal hepatic function, abnormal renal function, endocrine and metabolic disorders (except for overweight), nervous system disorders or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorders, and immune system disorders, who in the opinion of the investigator should be excluded from the study due to the above-mentioned diseases, or other diseases that may interfere with the interpretation of study results.\n\n  7\\. The estimated glomerular filtration rate at screening is \\\u003C 90 mL\u002Fmin\u002F1.73m2 as calculated using the CKD-EPI equation.\n\n  8\\. Any malignant tumor suspected or diagnosed prior to screening. 9. Subjects with blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or subjects with bone marrow donation.\n\n  10\\. Subjects who have undergone major surgery (including but not limited to surgery requiring general anesthesia) or organ transplantation within 3 months prior to screening, or are still in a state of illness, trauma or incomplete recovery from surgery at the time of screening (e.g., significant impairment in daily living or working capacity compared to pre-illness\u002Finjury\u002Fsurgery status), or plan to undergo surgery during the study or within two months after the end of the study.\n\n  11.Subjects with allergic constitution, or a history of allergic diseases such as bronchial asthma, urticaria, and eczema.\n\n  12\\. Known or suspected intolerance or hypersensitivity to any biological drug and its excipients, or known allergy or clinically significant reaction to murine-derived, chimeric, or humanized proteins in monoclonal antibodies or antibody fragments.\n\n  13\\. Subjects who tested positive for human immunodeficiency virus (HIV) antigen antibody, treponema pallidum antibody, hepatitis B surface antigen (HBsAg) quantitative assay, hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening.\n\n  14.Use of Dupilumab Injection and other cytokine (including but not limited to tumor necrosis factor, interleukin, etc.) targeted agents before screening, or use of other drugs that may affect the judgment of this study result within 3 months before screening (including but not limited to Janus kinase (JAK) inhibitor, phosphodiesterase-4 inhibitor, Fc receptor antagonists (Rozanolixizumab, Efgartigimod, etc.), any biological drugs and preparations, etc.); or have used any biological agent containing immunoglobulins within 1 year before screening.\n\n  15.Subjects who have participated in any clinical trial of an unmarketed drug or vaccine and received medication within 3 months before screening or within 5 half-lives of the previous investigational medicinal product (whichever is longer), or subjects who plan to be vaccinated during the study period or within 2 months after the end of the study.\n\n  16\\. Subjects who have used prescription and over-the-counter (OTC) drugs, herbal medicines, traditional Chinese medicines, and Chinese patent medicines without the approval of the investigator within 14 days before administration at Visit 2 (V2).\n\n  17\\. Those who are investigators or employees of the study site, or family members of the employees or investigators.\n\n  18\\. The investigator believes that there is any condition that may cause the subject to be unable to complete this study or bring obvious risks to the subject, or other investigators believe that the subject has any condition that makes him\u002Fher unsuitable for participating in this study, or the subject may not be able to complete this clinical trial for other reasons.","55 Years",{"count":201,"type":20},198,[53],"This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects.\n\nIt is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.",[205],"Biosimilarity",[205],"2025-12-30",{"date":209,"type":31},"2026-01-12",{"date":164,"type":20},{"date":212,"type":20},"2026-07-17",{"name":37,"class":38},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":39},"100602851","phase-1-study-on-gastric-emptying-effect-and-drug-drug-interactions-of-gzr18-injection-100602851","NCT07128888","Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection","A Study to Evaluate the Effect of GZR18 Injection on Gastric Emptying and Its Drug-Drug Interactions With Digoxin, Rosuvastatin Calcium and Warfarin Sodium in Obese or Overweight Subjects","Inclusion Criteria:\n\n* 1.Obese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.\n\n  2\\. Male or female, 18 to 50 years of age at signing the ICF (both inclusive).\n\n  3\\. Body mass index (BMI) within 26-35 kg\u002Fm2 (both ends inclusive) at screening.\n\n  4\\. No abnormality or not clinically significant abnormality as judged by the investigator in physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, urinalysis, thyroid function and coagulation), 12-lead ECG, ultrasonography of liver, gallbladder, pancreas, and spleen + both kidneys, chest imaging examination and other results. (abnormal indicators related to obesity or overweight, and the investigator assesses that they have no impact on this study, they can be enrolled)\n\n  5\\. Subjects of childbearing potential with no birth plan from the signing of the ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Females of childbearing potential must not be lactating and must have negative results for blood pregnancy test at screening (including D-1).\n\nExclusion Criteria:\n\n* 1.Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disorders, endocrine diseases (except obesity), malignant tumors and other diseases that are judged by the investigator to have an impact on the evaluation of the results of this study.\n\n  2\\. History or existing diseases that increase the risk of subjects, such as hypoglycemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of acute biliary pancreatitis at screening (e.g., silt-like lithiasis, gallbladder or bile duct stone ≤ 5 mm in diameter)，newly diagnosed cholecystitis at screening.\n\n  3\\. Subjects with previous or existing clinically significant digestive system diseases who are judged unsuitable for the study by the investigator, such as history of active peptic ulcer or hemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), continuous use of drugs affecting gastrointestinal motility for ≥ 1 week (including but not limited to domperidone, mosapride, macrolides), and acute hemorrhoidal attacks within the past three months.\n\n  4\\. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.\n\n  5\\. Subjects who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or subjects with acute diseases or concomitant medication from the screening period to before administration of the investigational medicinal product (IMP).\n\n  6\\. Subjects with severe infection or unexplained infection within 4 weeks before screening.\n\n  7\\. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.\n\n  8\\. Subjects with allergic constitution prior to screening, or a history of bronchial asthma, eczema and other allergic diseases (except mild seasonal allergy), or a history of severe food allergy (such as laryngeal edema, shock), or known allergy to any ingredient in investigational medicinal products (IMPs) \\[GLP-1 receptor (GLP-1R) agonist, paracetamol, digoxin, rosuvastatin, warfarin and their excipients\\].\n\n  9\\. Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicines within 2 weeks prior to screening; or use of any GLP-1R agonists or drugs with the same mechanism of action to GLP-1R agonists \\[such as GLP-1R\u002Fglucagon receptor (GCGR) agonists or gastric inhibitory polypeptide receptor (GIPR)\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists\\] within 6 months prior to screening; or use of any weight loss drugs within 6 months prior to screening.\n\n  10\\. Subjects who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study.",{"count":222,"type":20},60,[53],"This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets.\n\nA total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender.\n\nThe study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)",[226],"Obesity or Overweight","2025-12-10",{"date":229,"type":31},"2025-12-12",{"date":231,"type":31},"2025-11-17",{"date":233,"type":20},"2026-07-05",{"name":37,"class":38},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":39},"100604550","phase-3-phase-iii-clinical-study-comparing-the-efficacy-and-safety-of-gzr18-injection-and-semaglutide-wegovy-in-adult-obese-or-overweight-subjects-100604550","NCT07150975","Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects","A Multicenter, Randomized, Open-Label, Parallel-Group Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide(Wegovy®) in Adult Obese or Overweight Subjects","Inclusion Criteria:\n\n1. Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.\n2. For subjects not diagnosed with type 2 diabetes at screening, the following criteria must be met:\n\n   At screening and Visit 2 (before randomization), the subject must be either obese (BMI ≥ 28 kg\u002Fm²) or overweight (24 kg\u002Fm² ≤ BMI \\\u003C 28 kg\u002Fm²), and concurrently present with at least one of the following conditions:\n   * Comorbidity of one or more of the following: hyperglycemia (see Appendix 1 for definition), hypertension, dyslipidemia (see Appendix 2 for definition), or fatty liver; ②Weight-bearing joint pain;\n\n     * Weight-related obstructive sleep apnea syndrome.\n3. For subjects with type 2 diabetes at screening, the following criteria must be met simultaneously:\n\n   Body mass index (BMI) ≥ 24 kg\u002Fm² at both screening and Visit 2 (before randomization); A confirmed diagnosis of type 2 diabetes for at least 90 days at screening, in accordance with the World Health Organization (WHO) 1999 diabetes diagnostic criteria and the 2011 supplementary diagnostic criteria (HbA1c-based diagnosis is recommended); Within 90 days prior to screening: ① Management through diet and exercise alone, with no use of any antidiabetic medications; or ② Treatment of type 2 diabetes with a stable dose of metformin monotherapy, where the metformin dose is ≥ 1500 mg\u002Fday or the maximum tolerated dose (\\\u003C 1500 mg\u002Fday but ≥ 1000 mg\u002Fday); or ③ Treatment of type 2 diabetes with a stable dose of metformin (≥ 1500 mg\u002Fday or the maximum tolerated dose (\\\u003C 1500 mg\u002Fday but ≥ 1000 mg\u002Fday)) combined with a stable dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i); Glycated hemoglobin (HbA1c) measured by the central laboratory at screening is 7.0-10.5% (inclusive of both endpoints); Fasting plasma glucose measured by the central laboratory at screening is \\\u003C 15 mmol\u002FL.\n4. Prior to screening, the subject has been managed by diet and exercise alone for at least 12 weeks, and the body weight change has been \\\u003C 5% within the past 12 weeks (based on self-report).\n5. Subjects of childbearing potential must have no childbearing plans from the time of signing the informed consent form to 8 weeks after the last dose, and voluntarily adopt effective contraceptive measures, with no plans for sperm\u002Fegg donation. Females of childbearing potential must not be breastfeeding, and the pregnancy test results must be negative at both screening and Visit 2 (before randomization).\n6. The subject must be able to understand the procedures and methods of this study, be willing and able to maintain a regular diet and exercise lifestyle during the study period, be willing and able to receive subcutaneous injection of the investigational product, and voluntarily sign the informed consent form.\n\n   \\-\n\nExclusion Criteria:\n\n1. For subjects without type 2 diabetes at screening, the following situations are excluded:\n\n   * Fasting plasma glucose ≥ 7.0 mmol\u002FL or glycated hemoglobin (HbA1c) ≥ 6.5% as measured by the central laboratory at screening.\n\n     * Diagnosis of any type of diabetes (excluding gestational diabetes) prior to screening.\n\n       * Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R\u002Fglucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists, or GIPR\u002FGLP-1R\u002FGCGR agonists, etc.) prior to screening.\n2. For subjects with type 2 diabetes at screening, the following situations are excluded:\n\n   * Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R\u002Fglucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists, or GIPR\u002FGLP-1R\u002FGCGR agonists, etc.) within 180 days prior to screening; or a history of poor blood glucose control efficacy or intolerance to the above-mentioned drugs (as assessed by the investigator).\n\n     * A history of diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state within 180 days prior to screening.\n\n       * Presence of severe chronic diabetic complications at screening (e.g., proliferative retinopathy or macular edema, painful diabetic neuropathy, intermittent claudication, or diabetic foot).\n\n         * A history of refractory or complicated urinary tract infections\u002Fgenital infections within 6 months prior to screening.\n3. Subjects with known or suspected allergies to glucagon-like peptide-1 (GLP-1) receptor agonists or their excipients.\n4. A history of substance abuse prior to screening.\n5. A history of alcohol abuse within 180 days prior to screening, defined as an average weekly alcohol intake exceeding 14 units (for males)\u002F7 units (for females) (1 standard unit is equivalent to 360 mL of beer, 150 mL of wine with 12% alcohol content, or 45 mL of spirits with 40% alcohol content).\n6. Presence of limb deformities or disabilities that affect height measurement.\n7. Previous receipt of bariatric surgery prior to screening, or planned receipt of bariatric surgery during the study period (exceptions include acupuncture for weight loss, liposuction, or abdominal liposuction performed more than 1 year prior to screening; and removal (or expulsion) of intragastric balloons more than 1 year prior to screening).\n8. Obesity caused by secondary diseases or medications, including: elevated cortisol (e.g., Cushing's syndrome), obesity due to pituitary or hypothalamic damage, etc.\n9. A history of severe hypoglycemia or grade 3 hypoglycemia within 180 days prior to screening.\n10. A personal history or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B prior to screening; or a history of malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).\n11. The investigator deems that the subject has any other factors that may affect the evaluation of efficacy or safety in this study, making them unsuitable for participation.\n\n    \\-",{"count":243,"type":20},420,[23],"This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.",[247],"Obesity\u002FOverweight in Adult","2025-11-20",{"date":250,"type":31},"2025-11-25",{"date":252,"type":31},"2025-09-23",{"date":254,"type":20},"2027-06-30",{"name":37,"class":38},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":39},"100603785","phase-1-study-of-pharmacokinetics-and-safety-of-gzr18-injection-in-subjects-with-renal-impairment-and-normal-renal-function-100603785","NCT07141030","Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function","To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment","Inclusion Criteria:\n\n* 1.Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.\n\n  2.Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing ICF.\n\n  3.Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.\n\n  4.Subjects weighing ≥ 50 kg and 20 ≤ BMI ≤ 40 kg\u002Fm2 at screening.\n\n  5.Subjects with normal renal function must also meet the following conditions:\n  1. 90 mL\u002Fmin ≤ individual's GFR \\\u003C 130 mL\u002Fmin at screening (see Appendix 2: Formulas Involved in the Protocol for the calculation formula).\n  2. Subjects with normal laboratory test results, vital signs, ECG, physical examination, chest AP view, abdominal B-ultrasound, and other examination results at screening or without clinically significant abnormalities as assessed by the investigator.\n\n  6.Subjects with renal impairment must also meet all of the following:\n  1. Mild renal impairment group: 60 mL\u002Fmin ≤ individual's GFR \\\u003C 90 mL\u002Fmin at screening; moderate renal impairment group: 30 mL\u002Fmin ≤ individual's GFR \\\u003C 60 mL\u002Fmin at screening; severe renal impairment group: 15 mL\u002Fmin ≤ individual's GFR \\\u003C 30 mL\u002Fmin at screening.\n  2. Subjects with moderate and severe renal impairment should meet the diagnostic criteria for chronic kidney disease (outpatient medical records, hospitalization medical records or laboratory test results can be used as evidence). If the subject is receiving drug therapy, a stable medication regimen (at least within 2 weeks before administration) is required.\n\n     Exclusion Criteria:\n* 1.Subjects with allergic constitution, including those with a history of severe drug allergy or hypersensitivity reactions, and those known or suspected to be allergic to GLP-1 drugs or their excipients as considered by the investigator.\n\n  2.Subjects with a history of acute or chronic pancreatitis and pancreatic injury before screening; subjects with viral hepatitis, alcoholic liver disease, hepatic cirrhosis, autoimmune hepatitis and other liver diseases before screening; subjects with symptomatic gallbladder disease at screening.\n\n  3.Subjects who routinely receive dialysis or have a history of kidney transplantation or other organ transplantation before screening.\n\n  4.Subjects with severe infection, severe trauma, gastrointestinal surgery, or other major surgical operations within 6 months before screening.\n\n  5.Subjects with a history of moderate or major depression, suicidal tendency or suicidal behavior before screening; or other serious mental disorders (schizophrenia, bipolar affective disorder, etc.); or other psychiatric diseases that the investigator considers inappropriate for this study.\n\n  6\\. Subjects with a history of drug abuse or drug use within 1 year before screening; or subjects with positive result in a drug abuse screening (urine) (which cannot be justified by concurrent medications, such as those used for treating pain, anxiety, or insomnia as complications of renal disorder) at screening.\n\n  7.Subjects who have received a vaccine within 2 weeks before screening or are planning to be vaccinated during the study or within 1 month postdose.\n\n  8.Subjects who are positive for any indicator of human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening.\n\n  9.Subjects deemed unsuitable for inclusion by the investigator for other reasons.",{"count":264,"type":20},32,[53],"This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal renal function and those with mild, moderate or severe renal impairment.\n\nThe study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing\u002Fobservation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).",[268],"Obesity\u002FOverweight",{"date":270,"type":31},"2025-11-21",{"date":272,"type":31},"2025-04-11",{"date":274,"type":20},"2026-03-31",{"name":37,"class":38},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":39},"100605646","phase-3-a-phase-iiib-clinical-study-to-assess-the-efficacy-and-safety-of-gzr4-in-subjects-with-type-2-diabetes-mellitus-treated-with-basal-insulin-100605646","NCT07165223","A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin","Inclusion Criteria:\n\n* Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.\n* Males and females age ≥ 18 years at the time of informed consent.\n* The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization.\n* From signing the Informed Consent Form until 3 weeks after the end of treatment, female subjects of childbearing potential and male subjects and their partners must agree to use reliable contraceptive measures and not donate eggs (ova, oocytes) or sperm for assisted reproductive purposes.\n* According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.\n* Before screening, basal insulin was given once or twice a day. Or Insulin Icodec was given once-weeekly before screening.\n\nExclusion Criteria:\n\n* A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the investigational medicinal product or its excipients.\n* Subjects who are pregnant, lactating or planning to become pregnant during the study at screening.\n* Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of the previous investigational medicinal product, whichever is longer), or plans to participate in another clinical study before completing all scheduled assessments in this clinical study.\n* Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial infarction, stroke, or hospitalization due to angina unstable, transient ischaemic attack, or other acute cardiovascular events within 180 days before screening; or have a history of chronic cardiac failure classified as New York Heart Association Class III or IV at screening; or plan to undergo coronary, carotid, or peripheral arterial revascularisation procedures during the study; or have clinically significant abnormalities on the electrocardiogram (ECG) that the investigator considers inappropriate to participate in this study (such as second-degree type II or third-degree atrioventricular block, ventricular fibrillation, etc.).\n* History of malignant tumors within 5 years before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy at screening.\n* The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.\n* Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study.",{"count":283,"type":20},300,[23],"This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.",[287],"Diabetes",[289],"GZR4 insulin",{"date":250,"type":31},{"date":292,"type":31},"2025-10-17",{"date":294,"type":20},"2026-11-10",{"name":37,"class":38},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":39},"100604021","phase-1-study-of-pharmacokinetics-and-safety-of-gzr18-injection-in-subjects-with-liver-insufficiency-and-normal-liver-function-100604021","NCT07144098","Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function","Inclusion Criteria:\n\n* All Subjects:\n\n  1. Subjects who fully understand the study contents, study procedures and possible risks, can follow the contraindications and restrictions specified in this protocol, and voluntarily sign the informed consent form.\n  2. Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.\n  3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 19.0-32.0 kg\u002Fm2 (both inclusive).\n  4. Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation or egg donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.\n\n     Only for Subjects with Liver Dysfunction:\n  5. Chronic liver insufficiency caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis or other reasons, and after comprehensive assessment by researchers, the disease is not in the rapid progression stage.\n  6. Determined as grade A, B or C according to the Child-Pugh score, and no albumin was used within 21 days before screening.\n  7. Researchers determine the physical condition of those who are eligible for this test based on medical history inquiry, physical examination, vital signs, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.), 12-lead electrocardiogram, chest X-ray, B-ultrasound, etc.\n\nOnly for Subjects with Normal Liver Function:\n\n1. Matched with the subjects in the liver insufficiency group in terms of mean age (±10 years), sex ±1, mean weight (±10 kg), and mean BMI (±20%).\n2. Those whose clinical laboratory tests, vital signs, physical examinations, electrocardiograms, chest X-rays, B-ultrasound and other tests are normal, or who are evaluated as abnormal by the researcher but have no clinical significance.\n\nExclusion Criteria:\n\n* 1\\. Subjects with an allergic constitution, including those with a history of severe drug hypersensitivity or allergy, and known to be allergic to the investigational drug or GLP-1 drugs or any component in the investigational drug (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid and sodium hydroxide).\n\n  2\\. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.\n\n  3\\. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.\n\n  4\\. Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.\n\n  5\\. During screening, 12-lead electrocardiogram: QTcF \\> 470 msec (for males) or \\> 480 msec (for females).\n\n  6\\. Those with a history of severe active infection within one month prior to screening.\n\n  7\\. Subjects with a history of malignant tumors within the past 5 years (except for basal cell carcinoma of ski, squamous cell carcinoma of skin or in situ cancer of cervix).\n\n  8\\. Subjects with severe trauma, gastrointestinal surgery, or other major surgical operations within 4 weeks before screening.\n\n  9\\. Subjects who are unwilling or unable to comply with the study procedures specified in the protocol, or who are deemed unsuitable for participating in this clinical study by any investigator.",{"count":303,"type":20},24,[53],"This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency.\n\nThe study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing\u002Fobservation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).",[268],"2025-08-20",{"date":309,"type":31},"2025-08-27",{"date":311,"type":31},"2025-08-12",{"date":313,"type":20},"2027-01-26",{"name":37,"class":38},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":39},"100590981","phase-1-a-phase-i-study-to-evaluate-the-pk-and-pd-profiles-of-gzr102-injection-versus-gzr4-injection-and-gzr18-injection-given-separately-in-chinese-adult-overweight-subjects-100590981","NCT06974487","A Phase I Study to Evaluate the PK and PD Profiles of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects","A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects","Inclusion Criteria:\n\n* 1\\. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.\n\n  2\\. Subjects (male or female) age 18-60 years old (inclusive) at the time of signing ICF.\n\n  3\\. Body weight ≥ 60 kg, body mass index (BMI) ≥ 24 kg\u002Fm2 and \\\u003C 28 kg\u002Fm2 at screening.\n\n  4\\. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.\n\nExclusion Criteria:\n\n* 1\\. History of drug abuse prior to screening; or positive results for drug abuse at screening.\n\n  2\\. History of alcohol abuse defined as an average alcohol intake of more than 14 units per week (1 standard unit = 360 mL of beer or 150 mL of 12% wine or 45 mL of 40% spirits) within 6 months prior to screening.\n\n  3\\. Subjects who smoked \\> 5 cigarettes\u002Fday within 3 months prior to screening or who cannot stop using any tobacco products during the study.\n\n  4\\. Subjects with a history of allergy to ≥ 2 drugs, or known hypersensitivity or intolerance to the IMP or similar products and their excipients.\n\n  5\\. Presence of any suspected and\u002For definitively diagnosed malignancy at screening; or patients diagnosed with other malignancies within 5 years; 6. Previous or current medical history of cardiovascular, hematological, respiratory, digestive, urinary, endocrine\u002Fmetabolic, neurological, or psychiatric disorders that, in the investigator's judgment, may affect the study outcomes.\n\n  7\\. History of acute or chronic pancreatitis, biliary\u002Fgallbladder diseases , or pancreatic injury.\n\n  8\\. Major surgery (including but not limited to procedures requiring general anesthesia) within 3 months prior to screening; or history of organ transplantation (except corneal transplantation performed more than 4 months prior to screening); or incomplete recovery from illness, trauma, or surgery at screening (e.g., significant impairment in daily living or working capacity compared to pre-illness\u002Finjury\u002Fsurgery status); or planned surgery during the study period.\n\n  9\\. Blood donation or significant blood loss (\\> 400 mL), or blood transfusion in the 3 months prior to screening.\n\n  10\\. Presence of any clinically significant abnormalities in 12-lead electrocardiogram, vital signs (blood pressure, respiration, pulse rate, body temperature), physical examination, imaging examination, or laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, serum amylase, serum lipase, calcitonin) as determined by the investigator at screening..\n\n  11\\. Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody infection at screening.\n\n  12\\. History of organ transplantation, or acquired or congenital immune system disorders.\n\n  13\\. Participation in a clinical study of another investigational medicinal product (IMP), surgery, or device within 3 months before screening, or within 5 half-lives of the previous IMP (whichever is longer). Or plan to participate in another clinical study of an IMP, surgery, or device before completing all scheduled assessments in the clinical study.\n\n  14\\. Subjects who have used GLP-1 receptor agonists or drugs with the mechanism of action of GLP-1R agonists.\n\n  15\\. Subjects who are allergic to any food or have specific dietary requirements and cannot adhere to a standardized diet.\n\n  16\\. History of needle or blood phobia, or difficulty with blood collection; or inability\u002Funwillingness to undergo repeated venipuncture.\n\n  17\\. Subjects who were considered not suitable for the clinical study due to other reasons at the discretion of the investigator.","60 Years",{"count":324,"type":20},30,[53],"This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.\n\nSubjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.",[328],"Type 2 Diabetes","2025-05-07",{"date":331,"type":31},"2025-05-16",{"date":333,"type":20},"2025-05-08",{"date":335,"type":20},"2025-09-30",{"name":37,"class":38},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":39},"100576063","phase-3-a-clinical-study-to-evaluate-the-efficacy-tolerability-and-safety-of-bempedoic-acid-100576063","NCT06780410","A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid","A Phase III Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid in Patients with Hyperlipidemia Not Adequately Controlled by Statins","Inclusion Criteria:\n\n* 1\\. 18 years and older, male or female.\n* 2\\. 18 kg\u002Fm2 ≤Body Mass Index (BMI) ≤35 kg\u002Fm2.\n* 3\\. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes.\n* 4\\. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.\n\nExclusion Criteria:\n\n* 1\\. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.\n* 2\\. Fasting triglycerides (TG) ≥ 5.64 mmol\u002FL (≥ 500 mg\u002FdL) at screening.\n* 3\\. History of malignant tumors prior to screening.\n* 4\\. History of drug, alcohol, amphetamines, or other drug abuse.\n* 5\\. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer).\n* 6\\. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.\n* 7\\. Any other factors that the investigator believes makes the participant unsuitable for the study.",{"count":345,"type":20},240,[23],"This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.",[349],"Primary Hyperlipidemia",[351,352,353,354],"Bempedoic Acid","Hyperlipidemia","Efficacy","Safety","2025-01-13",{"date":357,"type":31},"2025-01-17",{"date":359,"type":31},"2024-12-20",{"date":361,"type":20},"2025-10",{"name":37,"class":38},""]