Gan & Lee Pharmaceuticals has officially initiated the GRADUAL-3 clinical study, a significant phase 3 trial evaluating the effectiveness of its once-monthly glucagon-like peptide-1 receptor agonist (GLP-1 RA), bofanglutide (research code: GZR18). Announced on November 27, 2025, this study aims to assess the injection’s potential in maintaining weight loss and enhancing long-term treatment adherence among adults with obesity or overweight.
The trial will explore the efficacy and safety of administering bofanglutide via subcutaneous injection every four weeks. Specifically, the primary endpoints include measuring the change and percentage change in body weight from baseline after 24 weeks of treatment. Leading the investigation is Professor Linong Ji from Peking University People’s Hospital, a prominent figure in obesity research.
Previous Studies and Clinical Insights
Gan & Lee has previously conducted two phase 3 studies, known as GRADUAL-1 and GRADUAL-2, which laid the groundwork for GRADUAL-3. In the GRADUAL-2 study, bofanglutide was the first GLP-1 RA to undergo a direct comparison with semaglutide (marketed as Wegovy®) in a head-to-head format among Chinese adults with obesity, both with and without type 2 diabetes. These studies not only evaluated the weight-loss efficacy of bofanglutide but also its impact on metabolic parameters and cardiovascular risk factors.
The comprehensive GRADUAL clinical development program encompasses three major phase 3 studies, aiming for a total enrollment of over 1,000 participants across China. GRADUAL-1 focuses on approximately 630 adults who have not achieved adequate weight loss through diet and exercise, while GRADUAL-2 involves around 471 adults. Both studies assess the safety and efficacy of bofanglutide injections over a 52-week period.
Revolutionizing Treatment Options
Bofanglutide injection is designed to offer a more convenient treatment regimen by reducing the frequency of injections. This shift is anticipated to improve patient adherence, which has been a notable challenge in GLP-1 RA therapy. By addressing issues such as weight regain and the durability of weight-loss efficacy, the GRADUAL-3 study aims to provide vital insights into long-term treatment strategies.
Developed by Gan & Lee, bofanglutide has shown promising results in previous clinical trials, demonstrating both weight-loss and glucose-lowering effects. With a safety profile comparable to existing GLP-1 RAs, the drug is under advanced development in the phase 3 stage, focusing on both obesity and type 2 diabetes treatment indications.
As Gan & Lee Pharmaceuticals continues to push the boundaries of obesity management, the results from the GRADUAL-3 study will be crucial in determining the future of once-monthly GLP-1 RA therapies and their role in promoting sustainable weight loss and improved health outcomes for individuals battling obesity.
