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Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2025-01-03
Completion Date
2026-05
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
HDM1702
Initiate 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 ®
Initiate 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.
Locations (1)
Peking University People's Hospital
Beijing, China