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Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes

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  • The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D uncontrolled on titrated insulin glargine ± metformin/SGLT2i for 40wks., respectively
  • ACHIEVE-2 showed reduced A1C (1EP) at Wk. 40 across both efficacy (-1.3, -1.7, -1.7% vs -0.8%) & treatment-regimen estimands (-1.2, -1.5, -1.6% vs -0.8%). ACHIEVE-5 also lowered A1C (1EP) at Wk. 40 [(-1.5, -2.1, -1.9% vs -0.8%) & (-1.6, -1.9, -1.8% vs -0.8%)]; both trials met their 2EPs
  • Also, Lilly plans global T2D submissions for orforglipron in 2026, obesity submission by year-end, with ACHIEVE-4 data expected in Q1’26

Ref: Eli Lilly | Image: Eli Lilly| Press Release

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