Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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 ®

Treatment groups

460 Participants
are divided into 2 treatment groups