Beijing – November 04, 2026 -- Gan & Lee Pharmaceuticals (Stock Code: 603087.SH) reported that once-monthly bofanglutide met the primary endpoint of its Phase IIIb GRADUAL-3 study, holding body weight near baseline over 24 weeks while the placebo group changed by 8.52%.
Both monthly dose groups beat placebo at P0.0001
Mean body-weight changes from baseline were 0.41% in the 24 mg once-monthly group and -0.12% in the 48 mg group, against 8.52% for placebo. Both comparisons reached P0.0001. The primary endpoint was the percentage change in body weight from baseline after 24 weeks.
Trial tests a step-down from biweekly to monthly dosing
Gan & Lee describes GRADUAL-3 as the first completed Phase IIIb sequential study worldwide to test weight-loss maintenance with once-monthly dosing in a randomized controlled design. The trial enrolled Chinese participants with obesity or overweight who had completed 52 weeks of biweekly bofanglutide in the GRADUAL-1 trial and met eligibility criteria.
Participants were randomized by their last dose (24 mg or 48 mg) to receive either bofanglutide or placebo once monthly for 24 weeks.
Cardiometabolic gains held, with no new safety signals
Monthly treatment maintained improvements in waist circumference, blood pressure and lipid levels. Bofanglutide showed a favorable safety and tolerability profile across all dose groups, and no new safety signals were identified. The most common adverse events were gastrointestinal, mostly mild to moderate and transient.
The company says the data show that moving to monthly dosing after intensive treatment can prevent weight regain and preserve earlier weight-loss benefits. Detailed results are planned for presentation at future scientific conferences and publication in international peer-reviewed journals.