Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Overweight or Obese
In brief
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.
Key facts
- Study ID
- NCT07036601
- Run by
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- People needed
- 276
- Starts
- 2025-01-06
- Expected to finish
- 2026-03-11
- Last updated by the study team
- 2025-06-25
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients 18 to 75 years of age, inclusive;
- Have a BMI ≥ 28 kg/m² or 24 ≤BMI< 28.0 kg/m² 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;
- Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
You may not qualify if…
- History of diabetes;
- 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);
- Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate <50 bpm or >100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT/RR\^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.
Where it is running
- The Second Xiangya Hospital of Central South University — Changsha, China (enrolling)
Full record on ClinicalTrials.gov
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