Semaglutide injection versus WEGOVY® for weight loss in Chinese adults with obesity
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients
This 48-week test compares a semaglutide injection made by Hangzhou Zhongmei with WEGOVY® to see if it helps Chinese adults with obesity lose weight and is similarly safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07036172 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label, parallel-controlled Phase 3 study compares an investigational semaglutide injection (HDM1702) with WEGOVY® in Chinese adults with obesity over 48 weeks. Participants are randomized 1:1 to receive once-weekly injections for 44 weeks followed by a 4-week safety follow-up, and all receive lifestyle counseling on diet and physical activity. The trial will measure weight loss, safety outcomes, and immunogenicity to determine biosimilarity between the two products. Key eligibility includes age 18–75, BMI ≥28 kg/m2, no history of diabetes, and stable weight in the prior 90 days.
Who should consider this trial
Good fit: Adults in China aged 18–75 with a BMI of at least 28 kg/m2, without type 1 or type 2 diabetes, who have had no more than a 5% weight change in the prior 90 days and can attend clinic visits in Beijing are ideal candidates.
Not a fit: People with diabetes, recent major cardiovascular events, a history of pancreatitis, certain thyroid cancers or MEN2, recent malignancy, or significant psychiatric disorders are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the investigational semaglutide could provide a similarly effective and safe alternative to WEGOVY® and potentially improve access or reduce cost for people with obesity.
How similar studies have performed: Large trials of branded semaglutide (WEGOVY®) have demonstrated substantial weight loss, but direct biosimilar Phase 3 comparisons are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent； 2. BMI ≥28 kg/m2； 3. A self-reported change in body weight no more than 5% within 90 days before screening. Exclusion Criteria: 1. History of type 1 and type 2 diabetes; 2. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device; 3. History or presence of chronic or acute pancreatitis; 4. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma; 5. A history or presence of suspected depression or other mental disorders; 6. Patient Health Questionnaire-9 score of ≥15 at screening 7. Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening; 8. History of malignant neoplasms within the past 5 years prior to screening;
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, 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.