A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

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.

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 change does not exceed 5% within the last 3 months;
4. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. 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;
2. Uncontrollable severe hypertension;
3. PHQ-9 score ≥ 15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute or chronic hepatitis;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
9. Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
10. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
11. Use of any medication or treatment that may have caused significant weight change within 90 days;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. History of alcohol and/or substance abuse or drug abuse;
15. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. The investigators determined that other conditions were inappropriate for participation in this clinical trial.