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

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.

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;