Gan & Lee Reports Positive Phase III Data for Insulin and Weight Loss Drugs

Gan & Lee Pharmaceuticals has reached key milestones in its metabolic disease pipeline, as its once-weekly insulin candidate Ludefen and the weight loss injection bofanglutide both hit primary endpoints in late-stage clinical trials across China and the United States.

The company’s SUPER-3 trial, involving 596 adults with type 2 diabetes, showed that weekly Insulin Ludefen (GZR4) achieved superior HbA1c reduction compared to once-daily insulin glargine. Participants using the experimental insulin saw a 1.58% reduction in HbA1c levels over 26 weeks, compared to 1.41% in the control group. Notably, the Ludefen cohort reported no severe hypoglycemic events, whereas the glargine group experienced three incidents, suggesting a favorable safety profile for the ultra-long-acting treatment.

Simultaneously, the GRADUAL-1 study in China demonstrated significant efficacy for bofanglutide. Adults with obesity receiving 48 mg doses achieved a 18.54% mean body weight reduction after 52 weeks, far outpacing the 1.11% reduction in the placebo group. A parallel U.S. Phase 2 study further validated these findings, with the 48 mg dosage yielding 15.18% weight loss over 36 weeks. Gan & Lee plans to present comprehensive data from these trials at upcoming scientific conferences as it continues its global development program.