By: IPP Bureau
Last updated : November 30, 2025 6:53 pm
Chinese biopharma giant Gan & Lee Pharmaceuticals has kicked off the Phase 3 trial of its once-monthly weight-loss injection.
GRADUAL-3 is the company's third large-scale phase 3 clinical study of the GLP-1 receptor agonist bofanglutide (GZR18) injection in adults with obesity or overweight. The trial will test a once-monthly subcutaneous injection aimed at maintaining weight loss and improving long-term treatment adherence.
The study will evaluate the efficacy and safety of once-monthly bofanglutide after 24 weeks of continuous treatment. Professor Linong Ji from Peking University People's Hospital is the lead principal investigator. The trial’s primary endpoints are the change and percentage change in body weight from baseline at Week 24.
Gan & Lee has already completed two phase 3 studies of bofanglutide—GRADUAL-1 and GRADUAL-2. Notably, GRADUAL-2 marked the first global head-to-head comparison of a GLP-1 RA with semaglutide 2.4 mg (Wegovy) in Chinese adults with obesity or overweight, with or without type 2 diabetes.
The GRADUAL-3 trial seeks to "explore the potential of once-monthly bofanglutide injection to maintain the achieved weight loss and improved long-term adherence," the company said. By reducing injection frequency, GRADUAL-3 aims to "support long-term treatment adherence and address key challenges associated with GLP-1 RA therapy, including weight regain and suboptimal durability of weight-loss efficacy over time."
Gan & Lee’s GRADUAL program is designed to thoroughly evaluate bofanglutide’s safety and efficacy in adults with obesity or overweight, with more than 1,000 participants planned across three phase 3 studies:
While GRADUAL-1 is 52-week study with 630 participants, evaluating weight-loss efficacy in adults not achieving results through diet and exercise, GRADUAL-2 is 52-week study with 471 participants, comparing bofanglutide with Wegovy in adults with or without type 2 diabetes. GRADUAL-3 is a 24-week study to test once-monthly injections for maintaining weight-loss effects.
Bofanglutide (GZR18) is a novel GLP-1 RA developed by Gan & Lee Pharmaceuticals. Its clinical development focuses on obesity/overweight and type 2 diabetes, showing “outstanding weight-loss and glucose-lowering effects” along with comprehensive metabolic benefits. Its safety and tolerability profile aligns with marketed GLP-1 RAs, and global development has now reached phase 3.