[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fujian Shengdi Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":485},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,65,86,106,128,147,169,190,210,231,252,273,292,312,332,351,371,388,407,426,446,467],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100645415","phase-1-a-mass-balance-study-of-14chrs-9057-for-injection-in-healthy-participants-100645415",false,"NCT07681479","A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants","Inclusion Criteria:\n\n1. Informed consent was obtained voluntarily\n2. Healthy males aged 18 \\~ 45 years (inclusive)\n3. Body weight ≥50 kg, BMI 19 \\~ 28 kg\u002Fm2 (inclusive)\n4. Adopt efficient contraceptive measures\n\nExclusion Criteria:\n\n1. Have a history of drug allergy, specific allergy, or allergic constitution\n2. Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo\n3. Have a history of risk factors for torsade de pointes\n4. During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL\u002Fmin\u002F1.73m2\n5. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms\n6. Chest X-ray findings deemed clinically significant by the investigator\n7. Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period\n8. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing\n9. Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration\n10. All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea\n11. Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest\u002Fabdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year\n12. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment",true,"MALE","18 Years","45 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up",[27],"Fluid Retention Due to Heart Failure","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2026-08",{"name":38,"class":39},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100644510","phase-3-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-hrs9531-tablets-in-overweight-or-obese-subjects-100644510","NCT07670884","A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects","Inclusion Criteria:\n\n1. Male or female subjects, 18-75 years of age at the time of signing informed consent;\n2. At screening visit, BMI ≥ 28 kg\u002Fm2 or ≥ 24 kg\u002Fm2 with at least one weight-related comorbidity;\n3. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;\n4. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;\n2. Uncontrollable severe hypertension;\n3. PHQ-9 score ≥ 15;\n4. Medical history or illness that affects body weight;\n5. History of diabetes;\n6. Acute or chronic hepatitis;\n7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;\n8. Any organ-system malignancies developed within 5 years;\n9. Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;\n10. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;\n11. Use of any medication or treatment that may have caused significant weight change within 90 days;\n12. History of bariatric surgery;\n13. Known or suspected hypersensitivity to trial product(s) or related products;\n14. History of alcohol and\u002For substance abuse or drug abuse;\n15. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;\n16. Surgery is planned during the trial;\n17. The investigators determined that other conditions were inappropriate for participation in this clinical trial.","ALL","75 Years",{"count":51,"type":21},425,[53],"PHASE3","This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.",[56],"Chronic Management of Body Weight","2026-06-22",{"date":59,"type":32},"2026-06-26",{"date":34,"type":21},{"date":62,"type":21},"2027-08",{"name":38,"class":39},2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},"100554983","phase-1-a-clinical-study-to-evaluate-the-effect-of-different-dosing-conditions-on-the-pharmacokinetics-of-hrs9531-tablets-in-healthy-participants-100554983","NCT06506175","A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants","A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants","Inclusion Criteria:\n\n1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.\n2. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.\n3. Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg\u002Fm\\^2 (both inclusive) at screening.\n4. Weight change does not exceed 5 kg within 3 months before screening.\n5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to trial product(s) or related products.\n2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.\n3. Abnormal and clinically significant blood pressure at screening.\n4. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.\n5. Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening.\n6. Presence of any clinically significant results in examination at screening visit.\n7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.\n8. Presence of - clinically significant ECG results.\n9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.\n10. Addiction to tobacco and alcohol.\n11. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.\n12. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.","55 Years",{"count":74,"type":21},100,[24],"The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.",[78,79],"Weight Management","Type 2 Diabetes",{"date":81,"type":32},"2026-06-24",{"date":34,"type":21},{"date":84,"type":21},"2026-09",{"name":38,"class":39},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":64},"100641350","phase-2-a-study-of-hrs-4729-injection-and-hrs9531-injection-in-participants-with-metabolic-dysfunction-associated-steatohepatitis-100641350","NCT07660848","A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Participants must have histologic diagnosis of MASH by liver biopsy\n3. Have liver fat content ≥8%\n4. Participants must have a body mass index (BMI) ≥24 kilograms per square meter (kg\u002Fm²) and ≤40 kg\u002Fm² with stable body weight for at least 3 months\n\nExclusion Criteria:\n\n1. Model for End-Stage Liver Disease (MELD) score \\> 12, or Child-Pugh (CTP) score \\> 6\n2. Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening\n3. History of liver cirrhosis and\u002For liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc.\n4. Previous or current liver disease due to other causes, including but not limited to: alcoholic steatohepatitis (ASH), drug-induced liver injury (DILI), viral hepatitis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hereditary hepatobiliary diseases (e.g., hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc.\n5. History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period\n6. Use of GLP-1 receptor agonists (including multi-target drugs or compound preparations containing GLP-1 receptor agonists) within 3 months prior to screening, or previous discontinuation of GLP-1 receptor agonists due to safety\u002Ftolerance reasons\n7. Known or suspected hypersensitivity to GLP-1 and\u002For GIP and\u002For GCG receptor agonists and\u002For their excipient",{"count":94,"type":21},160,[96],"PHASE2","The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.",[99],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","2026-06-16",{"date":57,"type":32},{"date":34,"type":21},{"date":104,"type":21},"2028-07",{"name":38,"class":39},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":40},"100635346","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-hrs9531-in-participants-with-atherosclerotic-cardiovascular-disease-100635346","NCT07551492","A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)","Inclusion Criteria:\n\n1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months\n2. The body mass index (BMI) at the time of screening was ≥24.0 kg\u002Fm ². Patients with type 2 diabetes have a BMI of ≥22.0 kg\u002Fm ²\n\nExclusion Criteria:\n\n1. Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter\u002Ffibrillation ablation, valve repair\u002Freplacement, carotid or peripheral artery recanalization within 30 days prior to the screening\n2. Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening\n3. When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, and intermittent claudication\n4. Coronary revascularization, atrial flutter\u002Ffibrillation ablation, valve repair\u002Freplacement, and carotid or peripheral artery recanalization are planned to be performed during the trial\n5. Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases\n6. Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ\n7. Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures\n8. Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery\n9. Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes\n10. Acute complications of diabetes occurred within one month before screening\n11. There are endocrine diseases that may significantly affect weight",{"count":114,"type":21},9262,[53],"The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.",[118],"Atherosclerotic Cardiovascular Disease","RECRUITING","2026-06-04",{"date":122,"type":32},"2026-06-05",{"date":124,"type":32},"2026-05-29",{"date":126,"type":21},"2031-06",{"name":38,"class":39},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":146,"locationsCount":40},"100617398","phase-2-phase-ii-clinical-study-of-hrs-9057-injection-in-patients-with-heart-failure-induced-fluid-retention-100617398","NCT07318103","Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention","A Multicentre, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable HRS-9057 in Patients With Heart Failure-induced Fluid Retention","Inclusion Criteria:\n\n1. Aged ≥18 years on the day of signing the informed consent, regardless of gender;\n2. Hospitalization due to heart failure within 72 hours prior to randomization.;\n3. At screening and prior to randomization, presence of heart failure symptoms (exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea, etc.) and at least one sign of fluid retention, including: auscultatory rales in the lungs, pitting edema of the lower extremities, pulmonary congestion confirmed by chest imaging;;\n4. NT-proBNP \\> 450 pg\u002FmL within 12 hours prior to randomization, or \\> 600 pg\u002FmL in patients with atrial fibrillation; or BNP \\> 150 pg\u002FmL, or \\> 200 pg\u002FmL in patients with atrial fibrillation.\n5. Judged to have poor response to loop diuretics before randomisation: presence of symptoms and signs of fluid retention after the administration of a cumulative dose of oral or intravenous loop diuretics equivalent to oral furosemide ≥40 mg (or equivalent doses of other loop diuretics#) within the past 12 hours.\n\nExclusion Criteria:\n\n1. Occurrence of myocardial infarction, stroke or transient ischemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe trauma or major\u002Fmoderate surgery within 1 month prior to screening;\n2. Coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), valve repair\u002Freplacement, carotid or peripheral arterial revascularization, mechanical circulatory support device therapy, heart transplantation within 1 month prior to screening or planned during the study; or presence of severe coronary artery disease or cerebrovascular disease without revascularization that may lead to acute events during hospitalization;\n3. The signs and symptoms of fluid retention are judged by the investigator as mainly attributable to non-cardiac causes, including acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated cirrhosis, nephrotic syndrome, and so on.\n4. The investigator determines that this hospitalization is due to acute heart failure requiring initial correction of the underlying cause, including: coronary atherosclerotic heart disease requiring revascularization, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, or symptomatic severe untreated primary valvular heart disease that may lead to acute events during hospitalization;\n5. Previously diagnosed with hypertrophic cardiomyopathy and currently still in the hypertrophic phase (obstructive or non-obstructive), or amyloid cardiomyopathy;\n6. Use of cardiac mechanical assist device at the time of screening;\n7. Presence of hypovolemia or peripheral hypoperfusion at screening, assessed by the investigator as requiring treatment with vasoconstrictors, positive inotropic agents, or volume resuscitation.\n8. Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;\n9. Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake;\n10. Unable to complete weight measurement or urine collection;\n11. Consciousness impairment at the time of screening, or hepatic encephalopathy at the time of screening or a history of hepatic encephalopathy;\n12. Any organ system malignancy within the last 5 years requiring ongoing treatment such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc.;\n13. History of drug abuse or substance use within 1 year prior to screening.\n14. Individuals with a body mass index (BMI) below 18.5 kg\u002Fm² ;\n15. Symptomatic hypotension and\u002For systolic blood pressure \\\u003C90 mmHg; 16. Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI2009\\] formula based on serum creatinine), or undergoing\u002Fplanned for haemodialysis or ultrafiltration therapy;\n\n17\\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× the upper limit of normal (ULN), except if assessed by the investigator as due to heart failure; 18. Serum sodium \\> ULN or \\\u003C125 mmol\u002FL; 19. Serum potassium \\> ULN 20. Known or suspected allergy to tolvaptan tablets, OPC-61815 injection, or HRS-9057 injection components; 21. Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as: signing the informed consent and using the investigational product (excluding placebo) or investigational medical device; or still within 5 half-lives of the investigational drug (whichever is longer); 22. Individuals who currently require blood transfusion therapy. 23. Participants with mental incapacity or speech disorders, or unable to fully understand or participate in the trial process, or unable to fully understand potential adverse reactions during the study; 24. Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use protocol-specified contraception during the trial and for 1 week after the last dose; 25. As judged by the investigator, any condition affecting participant safety or otherwise interfering with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.).",{"count":136,"type":21},153,[96],"Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention",[140],"Fluid Retention Caused by Heart Failure",{"date":142,"type":32},"2026-06-01",{"date":144,"type":32},"2025-12-31",{"date":36,"type":21},{"name":38,"class":39},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":40},"100634520","phase-1-a-study-to-evaluate-the-pharmacokinetics-of-hrs9531-injection-in-participants-with-mild-moderate-and-normal-hepatic-function-100634520","NCT07540754","A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function","A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function","Inclusion Criteria:\n\n1. Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be willing and able to comply with the protocol requirements to complete the study.\n2. Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of signing the informed consent form until 2 months after the last dose of the study drug; male participants with partners of childbearing potential must agree to use contraceptive measures and refrain from sperm donation from the time of signing the informed consent form until 2 months after the last dose of the study drug.\n3. Aged 18 to 65 years (inclusive), both male and female.\n4. Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever is longer).\n2. Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.\n3. Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.\n4. Drug abusers or those with a positive urine drug screening test.\n5. Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.\n6. Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.\n7. Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia).\n8. History of severe hypoglycemia.\n9. Previous significant gastric emptying abnormalities or factors affecting gastric emptying (e.g., history of gastric bypass surgery, pyloric stenosis), or severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (excluding surgeries with no significant impact on gastrointestinal motility, such as removal of gastrointestinal polyps, appendectomy, hemorrhoidectomy, etc.).\n10. Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.","65 Years",{"count":156,"type":21},24,[24],"This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild\u002Fmoderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.",[160,161],"Diabetes Mellitus","Weight Loss","2026-05-28",{"date":142,"type":32},{"date":165,"type":32},"2026-05-26",{"date":167,"type":21},"2027-02",{"name":38,"class":39},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":40},"100616652","phase-2-phase-ii-clinical-trial-evaluating-the-efficacy-and-safety-of-hrs-7249-and-shr-1918-in-patients-with-severe-hypertriglyceridemia-at-high-risk-of-acute-pancreatitis-100616652","NCT07308392","Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis.","Inclusion Criteria:\n\n1. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;\n2. Male or female aged ≥18 years and \\\u003C80 years on the day of signing the informed consent form.\n\nExclusion Criteria:\n\n1. History of gallstones at the time of screening or previously (except for patients who had their gallbladder removed more than 3 months ago);\n2. Acute pancreatitis that has clinically recovered ≤4 weeks before screening or randomization;\n3. Malignant tumor within 5 years before screening or randomization (except for non-melanoma skin cancer or cervical carcinoma in situ that has been radically treated);\n4. Grade 3\u002F4 heart failure at the time of screening or before randomization;\n5. Acute coronary syndrome (such as myocardial infarction, unstable angina), history of coronary artery bypass grafting, percutaneous coronary intervention, peripheral artery revascularization, cerebrovascular diseases (such as stroke, transient ischemic attack), heart failure hospitalization, etc., within 3 months before screening or randomization;\n6. Severe arrhythmias within 3 months before screening or randomization, such as recurrent symptomatic frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation with rapid ventricular rate;\n7. Severe infection within 3 months before screening;\n8. History or presence of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting lipid levels at screening;\n9. History or presence of hyperthyroidism or hypothyroidism at screening;\n10. Poorly controlled hypertension at screening or before randomization (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg);\n11. Diabetes with any of the following: a. Newly diagnosed within 12 weeks before screening or randomization; b. HbA1c ≥8.0% at screening; c. Type 1 diabetes;\n12. Unstable or severe liver, kidney, cardiovascular, psychiatric, neurological, endocrine, hematologic, or other diseases at screening or before randomization, where the investigator determines participation poses an unacceptable risk to the subject;\n13. Serious trauma or major surgery within 6 months before screening, or planning major surgery during the trial;\n14. Plasma exchange therapy within 4 weeks before screening or randomization, or planned during the trial;\n15. Use of other drugs significantly affecting lipid levels within 4 weeks before screening or randomization, or planned during the trial, such as traditional Chinese medicine containing statins (e.g., Zhibituo, Zhibitai), other lipid-lowering drugs and supplements (e.g., probucol, bile acid sequestrants, niacin, over-the-counter drugs, red yeast rice), GLP-1 agonists, other incretin analogues;\n16. Use of weight-loss drugs or undergoing weight-altering surgery within 2 months before screening or randomization, or planned during the study;\n17. History of drug abuse or alcohol abuse (including heavy drinking \\[average ethanol intake \\>80 g\u002Fday\\], previously diagnosed alcohol harmful use, alcohol dependence, alcohol poisoning, alcohol withdrawal, alcohol-related disorder, or alcohol-induced psychiatric or behavioral disorder);\n18. Significant lifestyle changes within 4 weeks before screening or randomization, or refusal to follow lifestyle guidance or limit alcohol intake to \\\u003C30 g\u002Fday during the study;\n19. eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula \\\u003C60 mL\u002Fmin\u002F1.73 m²;\n20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN);\n21. Total bilirubin or direct bilirubin ≥2 times ULN;\n22. Creatine kinase (CK) \\>1.5 times ULN;\n23. Platelet count \\\u003C100 x 10⁹\u002FL (or history of thrombocytopenia);\n24. Hemoglobin \\\u003C60 g\u002FL;\n25. Confirmed active syphilis, positive test result for human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab), positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies\u002Fml (or ≥200 IU\u002Fml, or if the detection lower limit is higher than 1000 copies\u002Fml or 200 IU\u002Fml, HBV-DNA ≥ detection lower limit);\n26. Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above 1.5 times ULN;\n27. Participation in any interventional drug clinical trial within 3 months prior to screening (participation is defined as administration of the investigational product to the subject), or still within 5 half-lives of the investigational product before screening, whichever is longer; previous participation in non-interventional clinical trials or device-related clinical trials may be judged by the investigator for inclusion;\n28. Pregnant or breastfeeding women;\n29. Women of childbearing potential who have not used contraception within 30 days prior to screening; women of childbearing potential and male subjects with partners of childbearing age who refuse to avoid donating sperm\u002Feggs from the time of signing the informed consent until the end of the follow-up period, or refuse to comply with relevant contraceptive requirements;\n30. Other conditions deemed by the investigator to make the subject unsuitable for participation in the trial.","80 Years",{"count":178,"type":21},108,[96],"Phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis",[182],"Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis","2026-05-24",{"date":162,"type":32},{"date":186,"type":32},"2026-02-25",{"date":188,"type":21},"2027-06",{"name":38,"class":39},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":40},"100639090","phase-3-phase-iii-study-of-hrs-5635-in-nucleostide-analogue-suppressed-hbeag-negative-patients-with-chronic-hepatitis-b-100639090","NCT07606950","Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;\n2. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;\n3. HBeAg negative at screening;\n4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;\n5. Need to take effective contraceptive measures；\n6. Volunteer to sign an informed consent.\n\nExclusion Criteria:\n\n1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;\n2. With autoimmune disease;\n3. History of solid organ transplantation or hematopoietic stem cell transplantation;\n4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;\n5. Malignant tumors were diagnosed within 5 years prior to randomization；\n6. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;\n7. Laboratory tests during the screening period were obviously abnormal;\n8. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;\n9. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;\n10. Participated in clinical study of other drugs (received experimental drugs);\n11. Pregnant or nursing women;\n12. Allergic to a drug ingredient or component;\n13. Other reasons for ineligibility as judged by the investigators.",{"count":198,"type":21},540,[53],"This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks) and the off-treatment follow-up (24 weeks), is up to approximately 88 weeks at maximum for each participant.",[202],"Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B","2026-05-19",{"date":165,"type":32},{"date":206,"type":21},"2026-06",{"date":208,"type":21},"2028-06",{"name":38,"class":39},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":64},"100637463","phase-2-a-research-study-to-investigate-the-efficacy-and-safety-of-hrs9531-tablets-in-participants-with-type-2-diabetes-mellitus-100637463","NCT07599410","A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus","A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.","Inclusion Criteria:\n\n1. Male or female, aged 18 to 70 years on the day of signing the informed consent form;\n2. Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);\n3. HbA1c between 7.5% and 10.5% at screening;\n4. Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;\n5. Fasting plasma glucose ≤ 15 mmol\u002FL;\n6. Body mass index (BMI) between 20.0 kg\u002Fm² and 40.0 kg\u002Fm² at screening;\n7. Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures and potential adverse reactions, and be able and willing to comply with protocol requirements to complete the study;\n8. Have no fertility plans from the signing of the informed consent form until 2 months after the last dose, and agree to use highly effective contraceptive measures as specified in the protocol.methods.\n\nExclusion Criteria:\n\n1. Participants with relevant abnormal test results at screening.\n2. Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.\n3. Participants with poorly controlled blood pressure.\n4. Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.\n5. Participants who experienced acute diabetic complications within 6 months prior to screening.\n6. Participants who experienced severe hypoglycemic events or recurrent hypoglycemic events within 6 months prior to screening.\n7. Participants with severe chronic diabetic complications at screening, or non-proliferative diabetic retinopathy requiring treatment during the trial.\n8. Participants with a past or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).\n9. Participants with a past or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic\u002Ftreatment requiring gallbladder disease.\n10. Participants with a past history of significant gastrointestinal diseases (such as severe diabetic gastroparesis, gastric outlet obstruction, inflammatory bowel disease, active ulcer, etc.), or who have undergone gastrointestinal surgery (excluding gastrointestinal polypectomy and appendectomy), or who are taking long-term medications that directly affect gastrointestinal motility.\n11. Participants with a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening.\n12. Participants with known or suspected depression, bipolar disorder, suicidal ideation, schizophrenia, or other severe psychiatric disorders; or participants who are mentally incompetent, have language barriers, are unable to fully understand the trial protocol, or are unwilling to cooperate with study site staff.\n13. Participants with a history of malignant tumor within 5 years prior to screening, except for cured localized cancers such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ.\n14. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n15. Any other conditions that, in the investigator's judgment, render the subject unsuitable for participation in this clinical trial.","70 Years",{"count":219,"type":21},240,[96],"The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.",[223],"T2DM","2026-05-14",{"date":226,"type":32},"2026-05-20",{"date":34,"type":21},{"date":229,"type":21},"2027-07",{"name":38,"class":39},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":48,"minAge":238,"maxAge":17,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":40},"100635934","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-hrs9531-injection-in-adolescents-with-obesity-100635934","NCT07559136","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity","A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity","Inclusion Criteria:\n\n1. Male or female subjects who are aged ≥12 years and \\\u003C18 years at the time of signing the informed consent;\n2. At screening, the BMI meets the obesity criteria according to \"WS\u002FT586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents\";\n3. Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);\n\nExclusion Criteria:\n\n1. Presence of clinically significant lab results at screening visit;\n2. Uncontrollable hypertension;\n3. Medical history or illness that affects your weight;\n4. History of diabetes;\n5. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;\n6. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;\n7. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;\n8. Pre-adolescent participants (Tanner phase I);\n9. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.\n10. Surgery is planned during the tria;\n11. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；\n12. In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.","12 Years",{"count":240,"type":21},48,[24],"The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity",[244],"Overweight and Obesity","2026-04-23",{"date":247,"type":32},"2026-04-30",{"date":249,"type":21},"2026-05",{"date":167,"type":21},{"name":38,"class":39},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":40},"100615837","phase-2-phase-ii-clinical-study-of-hrs-9563-in-patients-with-mild-to-moderate-hypertension-100615837","NCT07297797","Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-9563 in Patients With Mild to Moderate Hypertension","Inclusion Criteria:\n\n1. The subject voluntarily signs the informed consent form.\n2. Male or female, aged ≥ 18 years and ≤ 75 years;\n3. Patients with mild to moderate hypertension;\n4. At the Screening and Baseline periods, the mean sitting office systolic blood pressure is \\> 130 mmHg, and the 24-hour mean systolic blood pressure assessed by ABPM at Screening is ≥ 130 mmHg and \\\u003C 160 mmHg.\n\nExclusion Criteria:\n\n1. Secondary hypertension;\n2. Orthostatic hypotension;\n3. Type 1 diabetes or poorly controlled type 2 diabetes;\n4. Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;\n5. Presence of uncontrolled severe arrhythmia within 6 months prior to screening;\n6. Suspected allergy to the investigational drug or any of its components;\n7. Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;\n8. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;\n9. Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;",{"count":260,"type":21},234,[96],"This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.",[264],"Mild to Moderate Hypertension","2026-01-23",{"date":267,"type":32},"2026-01-26",{"date":269,"type":32},"2026-01-14",{"date":271,"type":21},"2027-10",{"name":38,"class":39},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":40},"100592532","phase-3-a-multicenter-randomized-double-blind-placebo-controlled-phase-iii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hrs9531-injection-in-subjects-with-obstructive-sleep-apnea-osa-and-obesity-who-are-on-positive-airway-pressure-ventilation-pap-therapy-100592532","NCT06994650","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy","Inclusion Criteria:\n\n1. Aged 18 -75 (inclusive), male or female Sex\n2. BMI ≥28.0 kg\u002Fm2；\n3. ≥3 months of diet\u002Fexercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.\n4. Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events\u002Fh.\n5. ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.\n6. Females\u002Fmales of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy\u002Fdonation plans. Females require negative pregnancy test ≤3 days pre-randomization and non-lactating.\n\nExclusion Criteria:\n\n1. Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-\u002Fhyperthyroidism) or monogenic\u002Fhereditary obesity syndromes excluded.\n2. Diabetes mellitus (excluding gestational diabetes).\n3. Prior\u002Fplanned OSA-related major surgeries (e.g., tonsillectomy\u002Fadenoidectomy) that may affect breathing.\n4. Have significant craniofacial abnormalities that may affect breathing at baseline\n5. Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas\u002Fhypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration\n6. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n7. Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis)；Chronic use of GI motility-affecting drugs；Severe GI disorders (e.g., active PUD, IBD)；GI surgeries (except non-motility-affecting procedures)\n8. Pancreatic disorders (acute\u002Fchronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic\u002Ftreated gallbladder disease\n9. Have used drugs or treatments that may cause significant weight gain or loss within 3 months\n10. Investigator-determined unsuitability\u002Funwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety\u002Foccupational\u002Fpersonal considerations).",{"count":280,"type":21},140,[53],"This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.",[284],"Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy","2026-01-22",{"date":267,"type":32},{"date":288,"type":32},"2025-08-13",{"date":290,"type":21},"2027-01",{"name":38,"class":39},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":40},"100597589","phase-3-efficacy-and-safety-of-hrs9531-in-participants-with-type-2-diabetes-treated-with-basal-insulin-100597589","NCT07060456","Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin","A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.","Inclusion Criteria:\n\n1. Male or female, able and willing to provide a written informed consent\n2. Diagnosed with type 2 diabetes ≥ 90 days；\n3. On stable once-daily dose of basal insulin alone or in combination with metformin and\u002For SGLT2 inhibitor ≥ 90 days;\n4. HbA1c was 7.5%\\~11.0% (both inclusive);\n5. Body Mass Index (BMI) ≥22 kg\u002Fm2 at screening.\n\nExclusion Criteria:\n\n1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;\n2. Have a history of severe hypoglycemia within t180 days prior to screening;\n3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；\n4. Have a history of malignancy within 5 years;\n5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;\n6. Participation in any clinical trial of an approved or non-approved investigational product\u002Ftreatment within the last 90 days;\n7. Any conditions that the Investigator judges might not be suitable to participate in the trial.",{"count":300,"type":21},300,[53],"The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and\u002For sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.",[79],"2025-12-28",{"date":306,"type":32},"2026-01-02",{"date":308,"type":32},"2025-07-25",{"date":310,"type":21},"2027-03",{"name":38,"class":39},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":72,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":40},"100604549","phase-1-relative-bioavailability-of-first-vs-second-generation-formulations-of-hrs9531-tablets-in-obese-or-overweight-subjects-100604549","NCT07150962","Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects","A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation","Inclusion Criteria:\n\n1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;\n2. Male subjects aged 18-55 years on the date of signing informed consent (inclusive);\n3. Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg\u002Fm2 (inclusive);\n4. The weight change within the previous 3 months should not exceed 5 kilograms.\n5. Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.\n\nExclusion Criteria:\n\n1. Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions;\n2. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;\n3. Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance;\n4. Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and\u002For more than 3 bowel movements per day;\n5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;\n6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;\n7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;\n8. Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period;\n9. Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.",{"count":320,"type":21},168,[24],"This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.",[324],"Overweight or Obesity","2025-11-14",{"date":327,"type":32},"2025-11-17",{"date":329,"type":32},"2025-10-15",{"date":84,"type":21},{"name":38,"class":39},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":18,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":40},"100607980","phase-1-a-single-ascending-dose-of-hrs-2162-in-healthy-subjects-100607980","NCT07195604","A Single Ascending Dose of HRS-2162 in Healthy Subjects","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects","Inclusion Criteria:\n\n1. The subjects voluntarily signed the informed consent form.\n2. Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible .\n3. ASA classification is Grade I (only Parts Two and three)\n4. Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg\u002Fm ².\n5. Adopt efficient contraceptive measures\n\nExclusion Criteria:\n\n1. Those with a past or current clinical acute or chronic disease\n2. Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .\n3. Those with a history of neuromuscular diseases or poliomyelitis\n4. Those with a history of anesthesia complications.\n5. Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance\n6. The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance\n7. The subject has a history of severe systemic allergies for any reason.\n8. The subjects took steroid hormone drugs within 7 half-lives or 14 days before administrationSmoke ≥5 cigarettes per day within 3 months prior to the study.\n9. History of drug abuse.\n10. Those who the researchers considered unsuitable for inclusion",{"count":340,"type":21},64,[24],"The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK\u002FPD",[344],"Reversal of Neuromuscular Blockade",{"date":327,"type":32},{"date":347,"type":32},"2025-09-25",{"date":349,"type":21},"2025-12",{"name":38,"class":39},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":72,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":40},"100587901","phase-1-a-phase-i-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-hrs-5817-injection-100587901","NCT06934408","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Injections of HRS-5817 Injection in Healthy Adult Volunteers With or Without Obesity","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.\n2. Males or females aged 18-55 years old (inclusive).\n3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.\n4. Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months.\n5. Female subjects of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a negative blood pregnancy test result before administration and not be breastfeeding. Male subjects whose partners are women of childbearing potential must agree to take highly effective contraceptive measures and avoid sperm donation from the signing of the informed consent form to 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and\u002For severe allergies to drugs or food, or history of severe anaphylaxis.\n2. History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator.\n3. Subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study.\n4. Subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer).\n5. Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study.\n6. Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.\n7. Other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.",{"count":359,"type":21},92,[24],"The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single and multiple doses in adults who are affected by obesity.",[363,364],"Obesity","Overweight",{"date":327,"type":32},{"date":367,"type":32},"2025-05-08",{"date":369,"type":21},"2027-04",{"name":38,"class":39},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":40},"100591009","phase-3-a-phase-iii-study-evaluating-the-efficacy-and-safety-of-hrs9531-injection-in-subjects-with-obstructive-sleep-apnea-osa-and-obesity-100591009","NCT06974851","A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy","Inclusion Criteria:\n\n1. The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study.\n2. Age between 18 and 75 years, male or female, at the time of signing the informed consent form.\n3. BMI ≥ 28.0 kg\u002Fm² at screening.\n4. Has been on a controlled diet and exercise regimen for 3 months or more, with a weight change of ≤ 5.0 kg in the past 3 months.\n5. Polysomnography (PSG) results at screening confirm OSA.\n6. Female participants of childbearing potential and male participants with partners of childbearing potential agree to use highly effective contraception from the time of signing the informed consent form until 2 months after the last dose, with no plans for pregnancy or donation of eggs\u002Fsperm during this period. Female participants of childbearing potential must have a negative pregnancy test within 3 days prior to randomization and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Laboratory Test Abnormalities:\n\n   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN.\n   2. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula based on serum creatinine).\n   3. Thyroid-stimulating hormone (TSH) \\\u003C 0.4 or \\> 6.0 mIU\u002FL.\n   4. Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments.\n2. Clinically Significant ECG Abnormalities:\n\n   ECG findings deemed clinically significant by the investigator, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), which may affect participant safety.\n3. Poorly Controlled Blood Pressure:\n\n   Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.\n4. PHQ-9 Score ≥ 15:\n\n   Patient Health Questionnaire-9 (PHQ-9) score ≥ 15.\n5. Medical History or Conditions Prior to Screening or Randomization:\n\n   1. Endocrine disorders or monogenic mutations causing obesity or hereditary obesity syndromes that may significantly affect weight.\n   2. Diabetes mellitus.\n   3. Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.\n   4. Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results.\n   5. Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA).\n   6. History of conditions affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal diseases, or prior gastrointestinal surgery.\n   7. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic\u002Ftreatment-requiring gallbladder disease.\n   8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).\n   9. Severe infections, significant trauma, or major\u002Fmoderate surgery within 1 month prior to screening.\n   10. Severe cardiovascular or cerebrovascular events within 6 months prior to screening, including decompensated heart failure (NYHA Class III or IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmias, or cardiac surgeries such as coronary artery bypass grafting or percutaneous coronary intervention.\n   11. Malignancy in any organ system within the past 5 years, regardless of evidence of local recurrence or metastasis (except cured local basal cell carcinoma, cervical carcinoma in situ, and prostate carcinoma in situ).\n   12. Presence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe psychiatric disorders.\n   13. Known or suspected history of alcohol and\u002For drug abuse or drug addiction.\n   14. Acute or chronic hepatitis or other severe liver diseases (excluding non-alcoholic fatty liver disease).\n   15. Severe hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome, hemolytic anemia, sickle cell disease) or any condition causing hemolysis or red blood cell instability (e.g., malaria).\n   16. Autoimmune diseases requiring systemic corticosteroid or immunosuppressive therapy during the study period.\n6. Medications or Treatments Prior to Screening:\n\n   1. Use of medications or treatments likely to cause significant weight gain or loss within 3 months prior to screening.\n   2. Medications or treatments judged by the investigator to potentially affect sleepiness assessments.\n   3. Prior or planned bariatric surgery (except liposuction performed more than 1 year ago).\n   4. Prior or planned endoscopic or device-based weight loss treatments, or device removal within the past 6 months (e.g., mucosal ablation, gastric artery embolization, intragastric balloons, duodenal-jejunal bypass sleeves).\n   5. Use of positive airway pressure (PAP) or other OSA treatments judged by the investigator to potentially interfere with study results (e.g., oral appliances, neurostimulation therapy), unless the participant is willing to discontinue such treatments 4 weeks prior to screening and during the study.\n   6. Requirement for supplemental oxygen.\n7. Other Exclusion Criteria:\n\n   1. Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as signing informed consent and using the investigational product (including placebo) or medical device, or still within 5 half-lives of the investigational drug (whichever is longer).\n   2. History of blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of a blood transfusion within 3 months.\n   3. Planned surgery during the trial (except minor surgeries deemed by the investigator to not affect the trial).\n   4. Participants with mental incapacity or language barriers unable to fully understand or participate in the trial.\n   5. Any condition judged by the investigator to affect participant safety or interfere with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.).\n   6. Investigators, research site staff, or other individuals directly involved in the execution of the protocol, and their immediate family members (e.g., spouse, legal partner, parents, children, or siblings). Employees of Hengrui Company are also excluded.",{"count":280,"type":21},[53],"A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity",[382],"Bstructive Sleep Apnea (OSA) and Obesity",{"date":327,"type":32},{"date":308,"type":32},{"date":386,"type":21},"2026-12",{"name":38,"class":39},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":40},"100548772","phase-2-a-multicenter-randomized-open-parallel-designed-study-to-evaluate-the-efficacy-and-safety-of-hrs-5635-injection-alone-or-in-combination-with-other-agents-in-patients-treated-for-chronic-hepatitis-b-100548772","NCT06425341","A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B","A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B","Inclusion Criteria:\n\n1. Meet the body mass index standard greater than or equal to 18.5 kg\u002Fm2 and less than 35 kg\u002Fm2;\n2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;\n3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;\n4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;\n5. Need to take effective contraceptive measures；\n6. Volunteer to sign an informed consent.\n\nExclusion Criteria:\n\n1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;\n2. With autoimmune disease;\n3. History of solid organ transplantation or hematopoietic stem cell transplantation;\n4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;\n5. Malignant tumors were diagnosed within 5 years prior to randomization；\n6. Infection requiring intervention within 2 weeks prior to randomization;\n7. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;\n8. Laboratory tests during the screening period were obviously abnormal;\n9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;\n10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;\n11. Participated in clinical study of other drugs (received experimental drugs);\n12. Pregnant or nursing women;\n13. Allergic to a drug ingredient or component;\n14. Other reasons for ineligibility as judged by the investigators.",{"count":396,"type":21},369,[96],"A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.",[400],"Chronic Hepatitis B",{"date":327,"type":32},{"date":403,"type":32},"2024-06-06",{"date":405,"type":21},"2027-01-19",{"name":38,"class":39},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":154,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":40},"100601974","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-a-single-subcutaneous-injection-of-hrs-9563-in-subjects-with-mild-hypertension-a-randomized-double-blind-placebo-controlled-phase-i-study-100601974","NCT07117474","Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-9563 in Subjects With Mild Hypertension: a Randomized, Double-blind, Placebo-controlled Phase I Study.","Inclusion Criteria:\n\n1. Males or infertile women aged 18-65 years (inclusive);\n2. Body mass index in the range of 19-28 kg\u002Fm2 (inclusive);\n3. Mild primary hypertension, without antihypertensive treatment, with a mean sitting systolic blood pressure ≥ 130 mmHg and ≤ 159 mmHg during screening and baseline, and a mean 24-hour ambulatory systolic blood pressure ≥ 130 mmHg during screening.\n\nExclusion Criteria:\n\n1. Abnormal daily life rhythm;\n2. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;\n3. Secondary hypertension;\n4. Mean sitting diastolic blood pressure ≥ 100 mmHg;\n5. Orthostatic hypotension;\n6. History of type 2 diabetes mellitus or poorly controlled blood glucose;\n7. Recently received any antihypertensive medications or medications that affect blood pressure.",{"count":414,"type":21},60,[24],"To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects",[418],"Subjects With Mild Hypertension","2025-08-04",{"date":421,"type":32},"2025-08-12",{"date":423,"type":32},"2024-12-24",{"date":349,"type":21},{"name":38,"class":39},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":40},"100531008","phase-2-a-trial-of-intravenous-hrs9432-in-the-treatment-of-subjects-with-candidemia-andor-invasive-candidiasis-100531008","NCT06194201","A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","A Multi-centre, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","Inclusion Criteria:\n\n1. Males or females ≥18 years；\n2. Established or clinical diagnosis of candidemia and\u002For IC ；\n3. Present of 1 or more systemic signs attribute to candidemia and\u002For IC 4 days prior to randomization;\n4. Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment；\n5. Able and willing to provide a written informed consent\n\nExclusion Criteria:\n\n1. Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis；\n2. Severe hepatic impairment in subjects with a history of chronic cirrhosis；\n3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement;\n4. Laboratory abnormalities in baseline specimens obtained at screening;\n5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening;\n6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \\>48 hours;\n7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;\n8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;\n9. Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;\n10. Females who are in gestation or lactating period or planned pregnancy during the study\n11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;\n12. In the judgment of the Investigator, other reasons unsuitable for study.",{"count":434,"type":21},40,[96],"The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and\u002For invasive candidiasis",[438],"Patients With Candidemia and\u002For Invasive Candidiasis","2024-11-15",{"date":441,"type":32},"2024-11-18",{"date":443,"type":32},"2024-04-27",{"date":206,"type":21},{"name":38,"class":39},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":452,"minAge":17,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":4},"100561871","phase-2-a-multicenter-randomized-double-blind-placebo-parallel-controlled-phase-ii-clinical-study-evaluating-the-efficacy-and-safety-of-hrs9531-injection-in-obese-subjects-with-polycystic-ovary-syndrome-100561871","NCT06595797","A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n1. With my consent and signed informed consent, I am willing and able to complete this study in accordance with the requirements of the experimental protocol\n2. Women aged 18-40 (including the threshold) on the date of signing the informed consent;\n3. Patients who meet the diagnostic criteria for polycystic ovary syndrome;\n4. Body mass index (BMI) ≥28 kg\u002Fm2;\n5. Have controlled diet and exercise for at least 3 months, and the weight change is less than 5 kg\n6. Within 2 months from the signing of the informed consent to the last drug use, there is no family planning and consent to take trial-approved contraceptive measures, and there is no egg donation plan\n\nExclusion Criteria:\n\n1. Endometrial biopsy is necessary as assessed by the investigators, and the pathology of the endometrial biopsy indicates significant abnormalities\n2. 12-lead electrocardiogram (ECG) results showing clinically significant abnormalities that may affect the safety of the subject, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, degree II or III atrioventricular block, etc.), and QTcF \\> 470 ms\n3. Poor blood pressure control (with or without antihypertensive therapy) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening\n4. PHQ-9 score ≥15 points\n5. The presence of endocrine disorders or medical history that may significantly affect body weight\n6. Presence of other medical conditions or history that may cause hyperandrostenia or irregular menstruation\n7. Presence of a history of gynecological conditions that may affect the evaluation of menstruation (including, but not limited to, history of hysterectomy, vaginal atresia, uterine adhesions)\n8. Abnormal uterine bleeding for reasons other than PCOS or unexplained abnormal uterine bleeding occurred within 6 months\n9. Endometrium-related surgery within 1 year indicated significant pathological abnormalities of endometrial tissue, and safety risks were assessed by researchers\n10. History of pregnancy, miscarriage, childbirth or breastfeeding within 6 months\n11. Have any disease or history that affects gastric empty. such as gastric bypass surgery, pyloric stenosis, etc., long-term use of drugs that directly affect gastrointestinal motility, serious gastrointestinal disease (such as active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (except surgery that has no significant effect on gastrointestinal motility), Such as gastrointestinal polypectomy, appendectomy and hemorrhoid surgery);\n12. A history or disease of acute or chronic pancreatitis or pancreatic injury; Patients with a history of acute cholecystitis or symptomatic\u002Ftreatable gallbladder disease (except those who had previously undergone cholecystectomy and were deemed eligible by the investigator to be enrolled);\n13. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2);\n14. Severe infection, severe trauma, or major or major surgery in the previous 6 months\n15. A history of severe cardiovascular and cerebrovascular disease, including decompensated heart failure (New York Heart Association ratings III and IV), unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary bypass grafting or percutaneous coronary intervention within the previous 6 months;\n16. Any organ-system malignancy within the previous 5 years, regardless of evidence of local recurrence or metastasis, except cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ;\n17. Present or suspected depression, anxiety disorder, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness\n18. A known or suspected history of alcohol and\u002For drug abuse or drug use\n19. A history of acute or chronic hepatitis, or other serious liver disease other than alcoholic fatty liver disease;\n20. A history of unstable or rapidly progressing kidney disease or end-stage kidney disease\n21. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned for the study period;\n22. Participated in a clinical trial of any drug or medical device within the previous 3 months, defined as signing informed consent and using the investigational drug (including placebo) or the investigational medical device; Or is still in the trial drug within 5 half-lives (whichever is older);\n23. Those who have donated blood or lost blood ≥400 mL in the previous 3 months, or received blood transfusion\n24. Surgery is planned during the trial period (except for minor surgery that the investigator believes will not affect the trial);\n25. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;\n26. Researchers and relevant staff of the research Centre or others directly involved in the implementation of the programme, as well as members of their immediate family (e.g. spouse, legal partner, parents, children or siblings); Hengrui company staff;\n27. There are circumstances (medical, psychological, social or geographical factors, etc.) that, in the investigator's judgment, affect the subject's safety or any other conditions that interfere with the evaluation of the test results.","FEMALE","40 Years",{"count":455,"type":21},144,[96],"Randomized, double-blind, placebo-controlled study of HRS9531 in PCOS subjects",[459],"Obese Subjects With Polycystic Ovary Syndrome (PCOS)","2024-09-11",{"date":462,"type":32},"2024-09-19",{"date":464,"type":21},"2024-09",{"date":349,"type":21},{"name":38,"class":39},{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":154,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":4},"100559572","phase-2-a-study-of-hrs9531-injection-in-obese-subjects-with-obstructive-sleep-apnea-100559572","NCT06565871","A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA)","Inclusion Criteria:\n\n1. Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.\n2. At screening visit, BMI 24-42kg\u002Fm2(both inclusive)\n3. Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.\n4. At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG\n\nExclusion Criteria:\n\n1. Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;\n2. Diabetes (except gestational diabetes)\n3. There are diseases that may require systemic glucocorticoid therapy during the study period\n4. Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.\n5. Previous or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)\n6. In or suspected of depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness;\n7. Use of drugs or treatments that may lead to significant weight gain or loss within 3 months, use of stimulants and hypnotics, mirtazapine, opioids, trazodone within 3 months;\n8. Patients with a history of blood donation or blood loss ≥400 ml within 3 months prior to screening, or receiving blood transfusions within 3 months\n9. During the screening or before randomization ,laboratory examination meets the following conditions:\n\nFasting blood glucose ≥7.0 mmol\u002FL, or HbA1c ≥6.5%; Hemoglobin \\\u003C100 g\u002FL; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× upper limit of normal range (ULN), total bilirubin (TBIL) ≥2.0×ULN; Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2 (calculated based on serum creatinine using CKD-EPI formula); Fasting triglyceride (TG) \\>5.64 mmol\u002FL (500 mg\u002Fdl); calcitonin ≥50 ng\u002FL; Blood amylase or lipase ≥3×ULN; Thyroid stimulating hormone (TSH) \\\u003C0.4 or \\>6.0 mIU\u002FL; Abnormalities in other laboratory tests that the investigator determines may affect the assessment of efficacy or safety;\n\n10、The 12-lead electrocardiogram (ECG) examination revealed clinically significant abnormalities that the investigators determined may affect the safety of the subject and QTcF\\>450 ms; 11、Poor blood pressure control: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥110 mmHg, or diastolic blood pressure ≥100mmHg and deemed unsuitable for study by investigator; 12、Clinically relevant medical behavior or psychiatric disorder (other than OSA), that is associated with insomnia or excessive sleepiness in the past and at the time of screening; 13、Severe infection, severe trauma, or major or large surgery within 1 month prior to screening 14、Malignancy of any organ system within 5 years, regardless of evidence of local recurrence or metastasis; 15、A known or suspected history of alcohol and\u002For drug abuse; 16、The presence of a serious hematological disorder; 17、Surgery is planned during the trial (except for minor surgery that the investigators believe will not affect the trial) 18、Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process; 19、In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of test results.",{"count":178,"type":21},[96],"The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea",[78],"2024-08-20",{"date":480,"type":32},"2024-08-22",{"date":482,"type":21},"2024-08",{"date":349,"type":21},{"name":38,"class":39},""]