jetcityimage/iStock Editorial via Getty Images
Eli Lilly (NYSE:LLY) announced late Friday new data from a Phase 2 trial for its once-daily obesity therapy, orforglipron, indicating that the oral GLP-1 receptor agonist caused up to 14.7% weight reduction in adults.
The 36-week trial was designed to evaluate 12 mg, 24 mg, 36 mg, or 45 mg doses of orforglipron against placebo in those with obesity or overweight and at least one weight-related condition excluding type 2 diabetes.
For the primary endpoint at 26 weeks, orforglipron led to dose-dependent and statistically significant body weight reductions of 8.6%–12.6% across all doses, compared to 2.0% in placebo.
At week 36, the body weight reductions ranged from 9.4% to 14.7% for those in the orforglipron arm, compared to 2.3% in the placebo group. The trial participants recorded a mean body weight of 240 lb. (109 kg) at baseline.
Orforglipron’s safety profile was found to be consistent with those of other gut hormone-based treatments, with mild-to-moderate gastrointestinal side effects being the most commonly reported adverse events.
Additionally, Lilly (LLY) shared data for orforglipron from a Phase 2 trial designed to compare it against placebo and the company’s FDA-approved diabetes therapy, dulaglutide (Trulicity), in adults with type 2 diabetes.
Noting that the trial achieved both primary and secondary endpoints, LLY said that A1C, a biomarker of blood glucose level, indicated a mean reduction of up to 2.1% in those who took orforglipron at week 26. In comparison, the mean reduction in A1C approached 0.4% with placebo and 1.1% with dulaglutide.
Additionally, orforglipron caused weight reductions up to 10.1 kg compared to 2.2 kg and 3.9 kg for placebo and dulaglutide, respectively, in adults with type 2 diabetes.
Both sets of data were simultaneously published in medical journals and shared at a medical event conducted by the American Diabetes Association. Lilly’s (LLY) Phase 3 programs for orforglipron in obesity and type 2 diabetes are currently underway.
