Actively Recruiting
Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
Led by Tonghua Dongbao Pharmaceutical Co.,Ltd · Updated on 2025-06-25
276
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 to 75 years of age, inclusive
- BMI 63; 28 kg/m�B2 or BMI between 24 64 BMI < 28 kg/m�B2 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, with less than 5% self-reported weight change within the last 3 months
You will not qualify if you...
- History of diabetes
- History of obesity caused by endocrine diseases, monogenic mutations, or drug-induced causes such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism
- Weight gain resulting from increased non-fat mass (e.g., edema)
- Uncontrolled hypertension at screening: systolic blood pressure 63;160 mmHg and/or diastolic blood pressure 63;100 mmHg
- ECG findings at screening including heart rate <50 bpm or >100 bpm; QTcF prolongation (>450 ms for males, >470 ms for females); PR interval >200 ms; long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Xiangya Hospital of Central South University
Changsha, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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