BEIJING, Nov. 27, 2025 — Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) has announced the commencement of GRADUAL-3, its third extensive phase 3 clinical investigation involving the glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection. This study targets adults affected by obesity or who are overweight. During this trial, bofanglutide injection will be administered subcutaneously once every four weeks (monthly) to assess its potential for sustaining achieved weight loss and enhancing long-term patient adherence.
This phase 3 trial (Chinadrugtrials.org.cn: CTR20254659) aims to determine the effectiveness and safety of once-monthly bofanglutide injection on body weight following 24 weeks of continuous treatment. Professor Linong Ji of Peking University People’s Hospital is serving as the lead principal investigator for the study. The primary outcomes measured are the absolute and percentage change from baseline in body weight at Week 24.
Previously, Gan & Lee conducted two phase 3 clinical studies (GRADUAL-1 and GRADUAL-2) with bofanglutide injection for managing weight in adults with obesity or who are overweight. Notably, the GRADUAL-2 study marks the first instance globally where a GLP-1 RA has undergone a head-to-head, parallel-group comparison with semaglutide 2.4 mg (Wegovy®) in Chinese adults experiencing obesity or being overweight, irrespective of type 2 diabetes. These investigations are designed to thoroughly assess and corroborate the efficacy and safety of bofanglutide injection in individuals with obesity or who are overweight, alongside its comprehensive impact on metabolic markers and cardiovascular risk factors. The GRADUAL-3 clinical study is set to further explore the capability of once-monthly bofanglutide injection to maintain initial weight reduction and improve consistent long-term use. By reducing the frequency of injections and offering a more convenient treatment schedule, GRADUAL-3 is anticipated to bolster sustained adherence to treatment and tackle significant issues associated with GLP-1 RA therapy, such as weight regain and diminishing weight-loss efficacy over time.
GRADUAL Clinical Development Program
The GRADUAL clinical development initiative for bofanglutide injection is structured to thoroughly evaluate its effectiveness and safety in adults who are overweight or obese. Three large-scale phase 3 clinical trials are currently underway in China, projecting a total enrollment exceeding 1,000 participants.
- GRADUAL-1 is a 52-week, phase 3 clinical investigation enrolling approximately 630 Chinese adults with obesity or who are overweight, who have not achieved sufficient weight loss through diet and exercise. It evaluates the weight-loss efficacy and safety of bofanglutide injection.
- GRADUAL-2 is a 52-week, phase 3 clinical investigation in roughly 471 Chinese adults with obesity or who are overweight, who have not achieved sufficient weight loss through diet and exercise, with or without type 2 diabetes. This study assesses the weight-loss efficacy and safety of bofanglutide injection versus Wegovy ® (semaglutide 2.4 mg, for weight management).
- GRADUAL-3 is a 24-week, phase 3 clinical investigation designed to examine the efficacy and safety of once-monthly bofanglutide injection in sustaining weight-loss effects.
Bofanglutide injection
Bofanglutide injection (research code: GZR18) is an innovative GLP-1 RA developed by Gan & Lee Pharmaceuticals. Its current clinical development efforts concentrate on two primary indications: obesity/overweight and type 2 diabetes. Clinical studies have shown bofanglutide injection to deliver notable weight-loss and glucose-lowering benefits, in addition to comprehensive metabolic advantages. The overall safety and tolerability profile of bofanglutide aligns with that of commercially available GLP-1 RAs. Presently, the global advancement of bofanglutide has progressed to the phase 3 stage.
Forward-looking statements
Forward-looking declarations are based on our current expectations and assumptions as of the statement date. Actual outcomes may differ significantly from those expressed in these forward-looking statements due to various influencing factors, and we cannot guarantee that such results will be realized in the future. We assume no obligation to update or revise any forward-looking statements, whether due to new information, future occurrences, or otherwise.
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