A New Paradigm for Long-Term Weight Management: Once-Monthly Bofanglutide Maintenance Therapy Delivers Positive Results in Weight Control and Maintenance Over 24 Weeks -- Gan & Lee Pharmaceuticals' GRADUAL-3 Study Meets Its Primary Endpoint
BEIJING and BRIDGEWATER, Mass., Nov. 4, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Stock Code: 603087. SH) announced positive topline results from GRADUAL-3, a Phase III clinical study evaluating once-monthly administration of its independently developed glucagon-like peptide-1 receptor agonist (GLP-1 RA), bofanglutide injection, in Chinese participants with obesity or overweight.
GRADUAL-3 is the first completed Phase IIIb sequential study globally to evaluate the maintenance of weight-loss efficacy with once-monthly administration using a randomized controlled trial (RCT) design. The study was designed to evaluate the efficacy and safety of transitioning patients from an intensive treatment regimen of bofanglutide administered once every two weeks for 52 consecutive weeks to a once-monthly regimen for weight maintenance.
GRADUAL-3 is a Phase IIIb maintenance study based on the GRADUAL-1 trial. Participants with obesity or overweight who completed 52 weeks of treatment with bofanglutide administered once every two weeks in GRADUAL-1 and met the eligibility criteria were enrolled. Participants were randomized, according to their last administered dose (24 mg or 48 mg), to receive either bofanglutide or placebo once monthly for 24 weeks.
The primary endpoint was the percentage change in body weight from baseline after 24 weeks of treatment.
After 24 weeks of treatment, the mean percentage changes in body weight from baseline were 0.41% and -0.12% in the bofanglutide 24 mg and 48 mg once-monthly groups, respectively, compared with 8.52% in the placebo group (both P<0.0001).
These results demonstrate that, following substantial weight loss achieved with 52 weeks of bofanglutide administered once every two weeks, transitioning to once-monthly administration can effectively prevent weight regain following discontinuation of the intensive treatment regimen and maintain previously achieved weight-loss benefits. This study provides a new therapeutic paradigm for the long-term weight management of individuals with obesity or overweight.
In addition, once-monthly bofanglutide treatment maintained improvements in cardiometabolic parameters, including waist circumference, blood pressure, and lipid levels.
Bofanglutide demonstrated a favorable safety and tolerability profile across all dose groups, with no new safety signals identified. The most common adverse events during treatment were gastrointestinal adverse events in nature, most of which were mild to moderate in severity and transient.
Detailed results from GRADUAL-3 are planned for presentation at future scientific conferences and publication in international peer-reviewed journals.
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