A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
Recruiting
Phase 3
Interventional Study
Chronic Management of Body Weight
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 675 (estimated)
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
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About This Trial
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
3. Diet and exercise control for at least 3 months before screening visit, and the weight cha…
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