[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595757":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Tonghua Dongbao Pharmaceutical Co.,Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"THDBH120 injection","EXPERIMENTAL",null,[13],"Drug: THDBH120 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo of THDBH120 injection","PLACEBO_COMPARATOR",[18],"Drug: Placebo of THDBH120 injection",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Participants received THDBH120 by subcutaneous injection.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Participants received placebo by subcutaneous injection.",[15],[28],{"facility":29,"status":30,"city":31,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The Second Xiangya Hospital of Central South University","RECRUITING","Changsha","China","CN",{"type":35,"coordinates":36},"Point",[37,38],112.97087,28.19874,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Zhiguang Zhou","CONTACT","13873104348","zhouzg@hotmail.com",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595757","phase-2-phase-ii-study-of-thdbh120-injection-in-overweight-or-obese-subjects-100595757",false,"NCT07036601","Phase II Study of THDBH120 Injection in Overweight or Obese Subjects","A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects","Inclusion Criteria:\n\n* Male or female patients 18 to 75 years of age, inclusive;\n* Have a BMI ≥ 28 kg\u002Fm² or 24 ≤BMI\\\u003C 28.0 kg\u002Fm² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;\n* Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.\n\nExclusion Criteria:\n\n* History of diabetes;\n* History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);\n* Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n* A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate \\\u003C50 bpm or \\>100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT\u002FRR\\^0.33; \\>450 ms for males, \\>470 ms for females); PR interval \\>200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.","ALL","18 Years","75 Years",{"count":59,"type":60},276,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.",[66],"Overweight or Obese","2025-06-16",{"date":69,"type":70},"2025-06-25","ACTUAL",{"date":72,"type":70},"2025-01-06",{"date":74,"type":60},"2026-03-11",{"name":5,"class":6},1]