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

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called HS-20094 to see how it can help people who are overweight or obese lose weight. The main goal is to understand how effective this medication is over a period of time. The study will last for about 4 to 12 weeks while doses are adjusted, followed by 12 to 20 weeks of treatment, and then there will be a 6-week follow-up period to see how participants are doing.

To be eligible for this trial, participants should be between 18 and 65 years old and have a body mass index (BMI) of 24 or higher, along with some weight-related health concerns. They should also have been following a stable diet and exercise routine for at least the last three months without significant weight changes. Participants will need to avoid certain medical conditions and medications that could interfere with the study. If you join this trial, you can expect regular check-ins and support while taking the medication to see how it affects your weight.

Gender

ALL

Eligibility 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.