Gan & Lee Pharmaceuticals has officially commenced its third large-scale phase 3 clinical study, known as GRADUAL-3, to evaluate the efficacy of the glucagon-like peptide-1 receptor agonist (GLP-1 RA), bofanglutide (research code: GZR18). This study focuses on adults struggling with obesity or being overweight and aims to assess the potential of a once-monthly subcutaneous injection to sustain weight loss and enhance long-term treatment adherence.
The GRADUAL-3 study, registered under Chinadrugtrials.org.cn as CTR20254659, will investigate the safety and effectiveness of administering bofanglutide injection once every four weeks over a 24-week period. The primary endpoints include measuring changes in body weight and the percentage change from baseline at Week 24. The principal investigator leading this effort is Professor Linong Ji from Peking University People’s Hospital.
This initiative follows two previous phase 3 studies, GRADUAL-1 and GRADUAL-2, which evaluated the effectiveness of bofanglutide in managing weight among adults who have not achieved significant weight loss through diet and exercise. Notably, the GRADUAL-2 study marked a significant milestone as it was the first global head-to-head comparison of bofanglutide with semaglutide 2.4 mg, known as Wegovy®, in Chinese adults.
The GRADUAL clinical development program encompasses three large-scale phase 3 studies in China, with a total enrollment target exceeding 1,000 participants. GRADUAL-1 and GRADUAL-2 each last 52 weeks and aim to comprehensively assess the weight-loss efficacy and safety of bofanglutide injection. GRADUAL-1 involves approximately 630 participants, while GRADUAL-2 includes around 471 participants, some of whom may have type 2 diabetes.
Bofanglutide, a novel GLP-1 RA, has shown promising results in clinical trials, demonstrating significant weight loss and glucose management capabilities. The drug’s safety and tolerability profile aligns closely with other marketed GLP-1 RAs, indicating a favorable risk-benefit balance for patients.
The introduction of a once-monthly dosing regimen is expected to improve treatment adherence, addressing common challenges associated with GLP-1 RA therapies, such as weight regain and the durability of weight-loss effects. By reducing the frequency of injections, Gan & Lee Pharmaceuticals aims to offer a more convenient option for individuals seeking effective long-term weight management solutions.
As the GRADUAL-3 study progresses, the company remains committed to advancing the understanding of bofanglutide’s impact on weight management and its potential to improve overall health outcomes for individuals with obesity. With the global development of bofanglutide now at the phase 3 stage, further insights into its efficacy and safety are anticipated in the coming months.
According to the company, all forward-looking statements regarding the study and its outcomes are based on current expectations and assumptions. Actual results may differ due to various factors, and Gan & Lee Pharmaceuticals does not undertake any obligation to update these statements.
