Once-monthly bofanglutide maintained weight loss over 24 weeks in topline phase 3 results

1. Once-monthly bofanglutide maintained body weight after 52 weeks of treatment every 2 weeks, with mean changes of 0.41% and −0.12% versus 8.52% with placebo; both P<0.0001.

2. Gan & Lee reported that gastrointestinal adverse events were the most common, generally mild to moderate and transient, with no new safety signals identified.

Evidence Rating Level: 2 (Good)

2MM Brief: Gan & Lee Pharmaceuticals reported topline results from GRADUAL-3, a study of once-monthly bofanglutide for weight maintenance in Chinese adults with obesity or overweight. Participants who completed 52 weeks of bofanglutide treatment administered every 2 weeks in GRADUAL-1 and met eligibility criteria were randomized according to their last administered dose to receive bofanglutide or placebo once monthly for 24 weeks. The study evaluated 24-mg and 48-mg bofanglutide groups, and its primary endpoint was the percentage change in body weight from baseline after 24 weeks. Mean percentage changes in body weight were 0.41% in the 24-mg group and −0.12% in the 48-mg group, compared with 8.52% in the placebo group; both comparisons had P<0.0001. Gan & Lee also reported that once-monthly bofanglutide maintained improvements in waist circumference, blood pressure, and lipid levels. The company described the safety and tolerability profile as favorable across dose groups and reported no new safety signals. Gastrointestinal adverse events were the most common events during treatment and were generally mild to moderate and transient. The results are topline findings from a phase 3b maintenance study and have not been peer reviewed; detailed results are planned for presentation at future scientific conferences and publication in international peer-reviewed journals. The source did not report the number of participants, confidence intervals, or additional statistical results. In this study, transitioning from intensive every-2-week treatment to once-monthly bofanglutide was associated with maintenance of previously achieved weight loss over 24 weeks, although the findings require assessment in the planned full publication.

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