Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine

Core Insights - Eli Lilly's orforglipron, an investigational oral GLP-1 receptor agonist, demonstrated significant efficacy in lowering A1C levels and promoting weight loss in adults with type 2 diabetes during the Phase 3 ACHIEVE-1 trial [1][2][3] Efficacy and Safety - Orforglipron achieved an average A1C reduction of 1.3% to 1.6% from a baseline of 8.0% after 40 weeks, with 76.2% of participants reaching the ADA target A1C of <7% [2][4] - The trial showed that participants on the highest dose of orforglipron lost an average of 16.0 lbs (7.9%) [2][4] - The safety profile of orforglipron was consistent with the established GLP-1 class, with gastrointestinal-related adverse events being the most common [1][9] Study Design and Results - The ACHIEVE-1 trial was a 40-week, randomized, double-blind, placebo-controlled study involving 559 participants across multiple countries [12][13] - All doses of orforglipron (3 mg, 12 mg, 36 mg) met the primary endpoint of superior A1C reduction compared to placebo [1][4] - Improvements in A1C were observed as early as four weeks into the treatment [3][9] Future Developments - Eli Lilly plans to share topline results from additional trials (ACHIEVE-2 and ACHIEVE-3) later this year, which will compare orforglipron with other diabetes medications [10] - The company aims to submit orforglipron for regulatory approval for weight management by the end of this year and for type 2 diabetes treatment in 2026 [10][11]