Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
- Summary
- 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.
- Short title
- Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-03-11
- First posted
- 2025-06-25
- Registry last updated
- 2025-06-25
- Primary completion date
- 2026-02-13
- Start date
- 2025-01-06
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07036601
- ClinicalTrials.gov ID
- NCT07036601
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percentage change in body weight
Timeframe: Baseline, Week26
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Timeframe: Baseline, Week26
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Timeframe: Baseline, Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Timeframe: Baseline, Week26
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Timeframe: Baseline, Week26
Change from baseline in waist circumference after the treatment
Timeframe: Baseline, Week 26
Change from baseline in BMI after the treatment
Timeframe: Baseline, Week 26
Change from baseline in blood pressure after the treatment
Timeframe: Baseline, Week 26
Change from baseline in HbA1c after the treatment
Timeframe: Baseline, Week 26
Change from baseline in total cholesterol after the treatment
Timeframe: Baseline, Week 26
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
Timeframe: Week 30
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaRecruiting