A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

• Status: Recruiting
• Trial end date: 2024-10-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight. The study period including 4-12 weeks dose titration and 12-20 weeks maintain treatment and 6 weeks follow up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

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

2. BMI≥28.0kg/m2 or 24≤BMI<28.0 kg/ m2 with at least 1 weight-related comorbidity at screening visit.

3. 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. poor-controlled hypertension. 3. PHQ-9 score≥15. 4. Medical history or illness that affects your weight. 5. Use of any medication or treatment that may have caused significant weight change within 3 months.

6. History of bariatric surgery. 7. History of diabetes. 8. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.

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

10. 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.

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

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

13. 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.

14. Known or suspected hypersensitivity to trial product(s)or related products. 15. Female who is pregnant,breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.

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

17. In the judgment of the investigator,there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.