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Lilly’s Oral GLP-1 Orforglipron Beats Farxiga and Placebo in Two Phase 3 Diabetes Trials

The company targets an obesity filing this year with diabetes submissions planned for 2026.

Overview

  • Topline results from ACHIEVE-2 and ACHIEVE-5 showed significant A1C reductions and weight loss in adults with type 2 diabetes, meeting all primary and key secondary endpoints at 40 weeks.
  • In ACHIEVE-2, orforglipron reduced A1C by up to about 1.7 percentage points versus roughly 0.8 points with dapagliflozin (Farxiga) in patients inadequately controlled on metformin.
  • In ACHIEVE-5, orforglipron lowered A1C by up to about 2.1 percentage points versus roughly 0.8 points with placebo in patients on titrated insulin glargine, with or without metformin and/or an SGLT2 inhibitor.
  • Lilly reported improvements in cardiovascular risk factors and a safety profile consistent with prior studies, with mostly mild-to-moderate gastrointestinal events, discontinuation rates in line with earlier data, and no hepatic safety signal observed.
  • Detailed data will be presented at a future medical meeting, and the final registration study, ACHIEVE-4, is expected to read out in the first quarter of 2026.