Tests THDBH120 injection against placebo for weight loss in adults with obesity
Tests THDBH120 injection against placebo in adults who are overweight or obese.
Plain-language title generated from the registry record
Registry title: Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07036601, who can take part
Where in China
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Trial code
- NCT07036601
- Record updated
- 25 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.