NCT07036172RecruitingPhase 3
Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
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
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 16 Jun 2025
- Start date
- 3 Jan 2025
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07036172
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 460
- From 3 Jan 2025 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- 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;
Other illness
- History of type 1 and type 2 diabetes;
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;
- A history or presence of suspected depression or other mental disorders;
- History of malignant neoplasms within the past 5 years prior to screening;
Other
- History or presence of chronic or acute pancreatitis;
- Patient Health Questionnaire-9 score of ≥15 at screening
Who the study is looking for
- Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent；
- BMI ≥28 kg/m2；
- A self-reported change in body weight no more than 5% within 90 days before screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.