Evaluating HS-20094 for weight loss in overweight and obese adults in China
A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
This study is testing a new weight loss drug called HS-20094 to see if it helps overweight and obese adults in China lose weight safely over a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 610 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06839664 on ClinicalTrials.gov |
What this trial studies
This phase 3, double-blind, randomized, placebo-controlled trial aims to assess the efficacy and safety of HS-20094 in Chinese adults aged 18-65 with overweight or obesity. Participants will receive either HS-20094 or a placebo via subcutaneous injection once a week for 48 weeks. The study will measure the percent change in body weight from baseline and the proportion of patients achieving a weight loss of at least 5% after treatment. The trial will last approximately 52 weeks in total.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults aged 18-65 with a BMI of 24 kg/m2 or higher and at least one obesity-related comorbidity, or a BMI of 28 kg/m2 or higher.
Not a fit: Patients with diabetes, significant recent weight changes, or a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective weight loss solution for overweight and obese patients, potentially improving their overall health and reducing obesity-related comorbidities.
How similar studies have performed: Other studies have shown promise in using similar approaches for weight management, but the specific efficacy of HS-20094 is being evaluated for the first time in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Male or female 18 to 65 years of age at the time of consent(cutoff value included). 2\. Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea. 3\. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening. Exclusion Criteria: * 1\. Diabetes mellitus 2. Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2) 6. History of moderate to severe depression, or have a history of serious mental illness 7. Any lifetime history of a suicide attempt 8. Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. Have a history of any malignancy within the past 5 years
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Cuicui
- Email: rmyyllwyh@163.com
- Phone: 010-88324516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.