RecruitingPhase 3NCT07036172

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


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

460 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares a biosimilar version of semaglutide injection to the brand-name weight-loss medication Wegovy in Chinese adults with obesity, to see if they work equally well. Both are weekly injections that help reduce body weight, and all participants also receive diet and exercise counseling throughout the 48-week study. You may be eligible if you are 18 to 75 years old with a BMI of 28 or higher, have not had significant weight changes recently, and do not have a history of diabetes, pancreatitis, or certain other medical conditions. Participation involves weekly injections, regular clinic visits, and lifestyle counseling over nearly a year, followed by a 4-week safety check-in. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDM1702

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.

DRUGWegovy ®

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

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NCT07036172