Eli Lilly announces orforglipron met primary endpoint in ACHIEVE-1 study

Eli Lilly (LLY) and Company announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine. In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand. In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of less than7%, 66.0% achieved an A1C of less than or equal to6.5%, and 25.8% achieved less than5.7%, defined as a normal A1C value