A Phase 3 clinical trial (NCT07036172) investigating the efficacy and safety of a semaglutide injection biosimilar compared to WEGOVY® in Chinese patients with obesity completed its primary phase on April 30, 2026. This randomized, open-label study enrolled 460 participants to evaluate the investigational drug against the established GLP-1 receptor agonist.

Background

Semaglutide is a widely recognized drug for obesity management, with formulations like WEGOVY® approved for chronic weight management. This trial focuses on a biosimilar injection, aiming to provide an alternative treatment option for patients in China.

Trial design

The Phase 3 study, NCT07036172, titled "Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients," is a randomized, open-label, parallel-controlled biosimilar comparison trial. It enrolled 460 participants diagnosed with obesity. Participants were randomized in a 1:1 ratio to receive either the investigational semaglutide injection or WEGOVY® injection once weekly for 44 weeks, followed by a 4-week safety follow-up. All participants also received lifestyle intervention counseling on diet and physical activity. The study aims to compare the efficacy, safety, and immunogenicity of the investigational drug against WEGOVY®.

What this means

The primary completion of this Phase 3 trial signifies a key milestone in the development of a potential semaglutide biosimilar for the Chinese market. Once results become available, they will provide crucial data on the comparative efficacy, safety, and immunogenicity of the investigational drug against WEGOVY® in Chinese patients with obesity. The availability of biosimilar options could potentially expand access to effective weight management therapies.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT07036172, titled "Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients," was updated on 2026-04-30 on clinicaltrials.gov.