Gan & Lee Pharmaceuticals Launches Phase 3 Trial for Once-Monthly GLP-1 Receptor Agonist Bofanglutide
核心洞察
Gan & Lee Pharmaceuticals (搜索) has initiated GRADUAL-3, a 24-week phase 3 clinical study evaluating once-monthly bofanglutide injection for weight management in adults with obesity or overweight.
The study represents the first Chinese once-monthly GLP-1 receptor agonist designed to maintain achieved weight loss and improve long-term treatment adherence through reduced injection frequency.
Bofanglutide is part of a comprehensive GRADUAL clinical development program with over 1,000 planned participants across three phase 3 studies, including a head-to-head comparison with semaglutide.
Gan & Lee Pharmaceuticals (搜索) announced the initiation of GRADUAL-3, a phase 3 clinical study evaluating its once-monthly glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide injection for weight management in adults with obesity or overweight. The study marks a significant milestone as the first Chinese once-monthly GLP-1 RA designed to address key challenges in obesity treatment, including weight regain and suboptimal durability of weight-loss efficacy over time.
Study Design and Objectives
The 24-week phase 3 study (CTR20254659) will evaluate the efficacy and safety of once-monthly bofanglutide injection administered subcutaneously once every four weeks. Professor Linong Ji from Peking University People's Hospital serves as the leading principal investigator. The primary endpoints focus on the change and percentage change from baseline in body weight at Week 24.
The study aims to explore bofanglutide's potential to maintain achieved weight loss while improving long-term adherence through a more convenient treatment regimen. By reducing injection frequency, GRADUAL-3 is expected to support long-term treatment adherence and address key challenges associated with GLP-1 RA therapy.
Comprehensive Clinical Development Program
The GRADUAL clinical development program encompasses three large-scale phase 3 clinical studies currently ongoing in China, with a planned total enrollment of more than 1,000 participants. Each study targets specific aspects of obesity treatment:
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 represents a landmark 52-week phase 3 clinical study in approximately 471 Chinese adults with obesity or overweight, with or without type 2 diabetes. This study is notable as 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.
Drug Profile and Development Status
Bofanglutide injection (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee Pharmaceuticals (搜索). The drug's clinical development currently focuses on two indications: obesity/overweight and type 2 diabetes. According to the company, 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. The global development of bofanglutide has advanced to the phase 3 stage, representing a significant achievement for the Chinese pharmaceutical company.
Clinical Significance
The GRADUAL 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 once-monthly dosing regimen addresses a critical need in obesity management by potentially improving patient adherence, a key factor in long-term weight management success.
The head-to-head comparison with semaglutide in GRADUAL-2 provides valuable comparative effectiveness data, positioning bofanglutide as a potential competitor in the rapidly expanding GLP-1 RA market for weight management.