Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
Recruiting · NCT07036172 · Interventional (participants receive a specific treatment) · Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HDM1702Wegovy ®
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- History of type 1 and type 2 diabetes;
- Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- History or presence of chronic or acute pancreatitis;
- 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;
- Patient Health Questionnaire-9 score of ≥15 at screening
- 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;
- History of malignant neoplasms within the past 5 years prior to screening;
Where it is running
1 location listed.
- Peking University People's Hospital - Beijing, China