About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- HDM1702
- Wegovy ®