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HRS9531 in Overweight or Obese Subjects
NCT07670884Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Oct 2027
- Countries
- 1
- Drugs
- HRS9531
- Conditions
- obesity
01
Overview
Phase 3, randomised, double-blind trial in obesity comparing HRS9531 Tablet Group with HRS9531 Tablet Placebo Group (2 arms). Primary endpoints: Percentage change from baseline in body weight at 52 weeks and Proportion of subjects with weight loss of >= 5% from baseline at 52 weeks. Started Jul 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
HRS9531 Tablet Group
Experimental arm receiving HRS9531 tablet.
HRS9531 Tablet Placebo Group
Placebo comparator arm receiving HRS9531 tablet placebo.
03
Who it enrols
Adults aged 18-75 with BMI >= 28 kg/m2 (or >= 24 kg/m2 with at least one weight-related comorbidity), who have maintained diet and exercise control for at least 3 months. Excludes patients with a history of diabetes, severe cardiovascular diseases, recent malignancies, or severe mental illness.
04
Endpoints
Primary
Percentage change from baseline in body weight
Proportion of subjects with weight loss of >= 5% from baseline
Secondary
Proportion of subjects with weight loss of >= 10% from baseline
Proportion of subjects with weight loss of >= 15% from baseline
Proportion of subjects with weight loss of >= 20% from baseline
Change from baseline in waist circumference
Change from baseline in body weight
Change from baseline in Body Mass Index
Change from baseline in blood pressure
Change from baseline in fasting plasma glucose
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