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.
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.
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;
Parallel
HDM1702
DrugInitiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
Wegovy ®
DrugInitiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
The percentage change in body weight from baseline to week 44
The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44
Change in waist circumference, body weight and BMI at week 44
Change in blood pressure and lipids at week 44
Adverse events
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