[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644510":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":11,"studyPopulation":11,"armGroups":57,"interventions":70,"overallOfficials":11,"centralContacts":78,"locations":84,"responsibleParty":121,"collaborators":11,"id":123,"slug":11,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":11,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":11,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":11,"overallStatus":141,"whyStopped":11,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage change from baseline in body weight after 52 weeks of treatment",null,"After 52 weeks of treatment.",{"measure":14,"description":11,"timeFrame":12},"Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment",[16,18,20,22,24,26,28,30,32,34,36,38,40,43],{"measure":17,"description":11,"timeFrame":12},"Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment",{"measure":19,"description":11,"timeFrame":12},"Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment",{"measure":21,"description":11,"timeFrame":12},"Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment",{"measure":23,"description":11,"timeFrame":12},"Change from baseline in waist circumference after 52 weeks of treatment",{"measure":25,"description":11,"timeFrame":12},"Change from baseline in body weight after 52 weeks of treatment",{"measure":27,"description":11,"timeFrame":12},"Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment",{"measure":29,"description":11,"timeFrame":12},"Change from baseline in blood pressure after 52 weeks of treatment",{"measure":31,"description":11,"timeFrame":12},"Change from baseline in fasting plasma glucose after 52 weeks of treatment",{"measure":33,"description":11,"timeFrame":12},"Change from baseline in fasting serum insulin after 52 weeks of treatment",{"measure":35,"description":11,"timeFrame":12},"Change from baseline in glycosylated hemoglobin after 52 weeks of treatment",{"measure":37,"description":11,"timeFrame":12},"Change from baseline in blood lipid after 52 weeks of treatment",{"measure":39,"description":11,"timeFrame":12},"Change from baseline in blood uric acid after 52 weeks of treatment",{"measure":41,"description":11,"timeFrame":42},"Number of treatment serious adverse events (SAEs) within 57 weeks","Within 57 weeks.",{"measure":44,"description":11,"timeFrame":42},"Number of treatment adverse events (AEs) within 57 weeks",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":11,"timePerspective":11,"maskingInfo":50},"RANDOMIZED","PARALLEL","HRS9531 tablets compared with placebo.","TREATMENT",{"masking":51,"maskingDescription":11,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"HRS9531 Tablet Group","EXPERIMENTAL","HRS9531 tablet.",[63],"Drug: HRS9531 Tablet",{"label":65,"type":66,"description":67,"interventionNames":68},"HRS9531 Tablet Placebo Group","PLACEBO_COMPARATOR","HRS9531 tablet placebo.",[69],"Drug: HRS9531 Tablet Placebo",[71,75],{"type":72,"name":73,"description":61,"armGroupLabels":74,"otherNames":11},"DRUG","HRS9531 Tablet",[59],{"type":72,"name":76,"description":67,"armGroupLabels":77,"otherNames":11},"HRS9531 Tablet Placebo",[65],[79],{"name":80,"role":81,"phone":82,"phoneExt":11,"email":83},"Qiannan Zhou, M.M","CONTACT","+86-0518-82342973","qiannan.zhou@hengrui.com",[85,105],{"facility":86,"status":11,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Henan Provincial People's Hospital","Zhengzhou","Henan","450003","China","CN",{"type":93,"coordinates":94},"Point",[95,96],113.64861,34.75778,{"lat":96,"lon":95},[99,103],{"name":100,"role":81,"phone":101,"phoneExt":11,"email":102},"Huijuan Yuan","+86-0371-65580371","hjyuan@zzu.edu.cn",{"name":100,"role":104,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":106,"status":11,"city":107,"state":108,"zip":109,"country":90,"countryCode":91,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Nanjing Drum Tower hospital","Nanjing","Jiangsu","210008",{"type":93,"coordinates":111},[112,113],118.77778,32.06167,{"lat":113,"lon":112},[116,120],{"name":117,"role":81,"phone":118,"phoneExt":11,"email":119},"Yan Bi","+86-025-83106666","biyan@nju.edu.cn",{"name":117,"role":104,"phone":11,"phoneExt":11,"email":11},{"type":122,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100644510",false,"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","18 Years","75 Years",{"count":133,"type":134},425,"ESTIMATED","INTERVENTIONAL",[137],"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.",[140],"Chronic Management of Body Weight","NOT_YET_RECRUITING","2026-06-22",{"date":144,"type":145},"2026-06-26","ACTUAL",{"date":147,"type":134},"2026-07",{"date":149,"type":134},"2027-08",{"name":5,"class":6},2]