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

Prior treatment

• 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;
• History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
• Use of any medication or treatment that may have caused significant weight change within 90 days;
• History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
• Surgery is planned during the trial;

Other illness

• Uncontrollable severe hypertension;
• Medical history or illness that affects body weight;
• History of diabetes;
• Acute or chronic hepatitis;
• Any organ-system malignancies developed within 5 years;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
• History of bariatric surgery;
• Known or suspected hypersensitivity to trial product(s) or related products;
• History of alcohol and/or substance abuse or drug abuse;
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Other

• PHQ-9 score ≥ 15;

• 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.