Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) announced the initiation of GRADUAL-3, its third large-scale phase 3 clinical study of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection in adults with obesity or overweight. In this study, bofanglutide injection will be administered subcutaneously once every four weeks (once-monthly) to explore its potential to maintain the achieved weight loss and improved long-term adherence.

This phase 3 study (Chinadrugtrials.org.cn: CTR20254659) is designed to evaluate the efficacy and safety of once-monthly bofanglutide injection on body weight after 24 weeks of continuous treatment. Professor Linong Ji from Peking University People's Hospital is the leading principal investigator of the study. The primary endpoints were the change and the percentage change from baseline in body weight at Week 24.

Previously, Gan & Lee has conducted two phase 3 clinical studies (GRADUAL-1 and GRADUAL-2) of bofanglutide injection for weight management in adults with obesity or overweight. In GRADUAL-2 study, bofanglutide injection is the first GLP-1 RA globally to be evaluated in a head-to-head, parallel-group comparison with semaglutide 2.4 mg (Wegovy^®) in Chinese adults with obesity or overweight, with or without type 2 diabetes. These studies are designed to comprehensively assess and confirm the efficacy and safety of bofanglutide injection in patients with obesity or overweight, as well as its overall impact on metabolic parameters and cardiovascular risk factors. The GRADUAL-3 clinical study will further explore the potential of once-monthly bofanglutide injection to maintain the achieved weight loss and improved long-term adherence. By reducing injection frequency and offering a more convenient treatment regimen, GRADUAL-3 is expected 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.

GRADUAL Clinical Development Program
The GRADUAL clinical development program of bofanglutide injection is designed to comprehensively evaluate its efficacy and safety in adults with overweight or obesity. Three large-scale phase 3 clinical studies are currently ongoing in China, with a planned total enrollment of more than 1,000 participants.

• GRADUAL-1 is a 52-week, phase 3 clinical study in approximately 630 Chinese adults with obesity or overweight who have not achieved adequate weight loss with diet and exercise, evaluating the weight-loss efficacy and safety of bofanglutide injection.
• GRADUAL-2 is a 52-week, phase 3 clinical study in approximately 471 Chinese adults with obesity or overweight who have not achieved adequate weight loss with diet and exercise, with or without type 2 diabetes, assessing the weight-loss efficacy and safety of bofanglutide injection compared with Wegovy ® (semaglutide 2.4 mg, for weight management).
• GRADUAL-3 is a 24-week, phase 3 clinical study designed to explore the efficacy and safety of once-monthly bofanglutide injection on maintaining weight-loss effect.

Bofanglutide injection
Bofanglutide injection (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee Pharmaceuticals. Its clinical development currently focuses on two indications: obesity/overweight and type 2 diabetes. Bofanglutide injection has demonstrated outstanding weight-loss and glucose-lowering effects in clinical studies, while also providing comprehensive metabolic benefits. The overall safety and tolerability profile of bofanglutide is consistent with that of marketed GLP-1 RAs. Currently, the global development of bofanglutide has advanced to the phase 3 stage.