Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent;

2. Male or female subjects, 18-65 years of age at the time of signing informed consent;

3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;

4. 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.

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 hypertension;

3. PHQ-9 score ≥15;

4. Medical history or illness that affects your weight;

5. History of diabetes;

6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;

7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;

10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;

11. Use of any medication or treatment that may have caused significant weight change within 3 months;

12. History of bariatric surgery;

13. Known or suspected hypersensitivity to trial product(s) or related products;

14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;

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. Mentally incapacitated or speech-impaired;

18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.