To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Inclusion criteria

• Able and willing to provide a written informed consent.
• Male or female subjects, ≥18 years of age at the time of signing informed consent.
• At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
• Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
• Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

Exclusion criteria

• Presence of clinically significant lab results at screening visit;
• Uncontrollable hypertension;
• PHQ-9 score ≥15;
• Medical history or illness that affects your weight;
• History of diabetes;
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• Known or suspected history of alcohol and/or substance abuse or drug abuse;
• History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
• Have received or plan to have an organ or bone marrow transplant during the study.
• The presence of any blood disorders that may interfere with HbA1c testing.
• Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
• Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
• Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
• Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
• Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
• Surgery is planned during the tria;
• Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
• In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.