Actively Recruiting
Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-06-25
460
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years and older up to 75 years at consent
- Body mass index (BMI) of 28 kg/m2 or higher
- Self-reported body weight change not exceeding 5% within 90 days before screening
You will not qualify if you...
- History of type 1 or type 2 diabetes
- Previous or planned obesity surgery or weight-loss device treatment during the trial
- History or presence of chronic or acute pancreatitis
- Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- History or presence of suspected depression or other mental disorders
- Patient Health Questionnaire-9 score of 15 or higher at screening
- Uncontrolled hypertension or recent (within 6 months) serious heart or brain events such as myocardial infarction, stroke, unstable angina hospitalization, or transient ischemic attack
- History of malignant tumors within 5 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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