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.
Male or female subjects, 18-75 years of age at the time of signing informed consent;
At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
Able and willing to provide a written informed consent.
Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
Uncontrollable severe hypertension;
PHQ-9 score ≥ 15;
Medical history or illness that affects body weight;
Parallel
HRS9531 Tablet
DrugHRS9531 tablet.
HRS9531 Tablet Placebo
DrugHRS9531 tablet placebo.
Percentage change from baseline in body weight after 52 weeks of treatment
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment
Change from baseline in waist circumference after 52 weeks of treatment
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