Evaluating HS-20094 for weight loss in overweight and obese Chinese adults
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
This study is testing if a new weight loss medication called HS-20094 can help overweight and obese Chinese adults lose weight over 24 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Harbin, Heilongjiang and 1 other locations) |
| Trial ID | NCT06118021 on ClinicalTrials.gov |
What this trial studies
This phase 2, double-blind, randomized, placebo-controlled trial investigates the efficacy of HS-20094 in Chinese adults aged 18-65 with overweight or obesity. Participants with a BMI of 24 kg/m² or higher, along with at least one obesity-related comorbidity, will receive either HS-20094 or a placebo over a 24-week period. The study includes a dose titration phase followed by a maintenance treatment phase, with primary endpoints focused on weight change and secondary outcomes assessing waist circumference and BMI. The trial aims to provide insights into the weight loss effects of HS-20094 in this population.
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.
Not a fit: Patients with a history of diabetes, significant cardiovascular issues, or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly aid in weight loss for individuals struggling with obesity and related health issues.
How similar studies have performed: Other studies have shown promise in weight loss interventions for obesity, but the specific approach with HS-20094 is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Harbin, Heilongjiang and 1 other locations
- the Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
- The Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
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.