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Eli Lilly’s Foundayo Meets Cardiovascular Safety Endpoint in Type 2 Diabetes Trial

Eli Lilly reported Phase 3 ACHIEVE-4 results showing Foundayo (orforglipron) met its primary endpoint of cardiovascular non-inferiority versus insulin glargine in adults with type 2 diabetes. MACE-4 risk fell 16% versus glargine, with prespecified analyses showing 53% lower cardiovascular death risk and 57% lower all-cause death risk. At 52 weeks, Foundayo reduced A1C by 1.6% and weight by 8.8%, while the glargine group gained 1.7% body weight.

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AI take

The significance here is not the glycemic or weight advantage — oral GLP-1s were already expected to compete on that front — but the cardiovascular and mortality data, which is the evidentiary bar payers and guidelines typically demand before a diabetes therapy displaces entrenched injectable insulin. A non-inferiority endpoint met with a favourable MACE-4 separation, plus markedly lower cardiovascular and all-cause death signals in prespecified analyses, shifts the commercial conversation from convenience toward outcomes. Whether these prespecified mortality findings hold up under fuller scrutiny, and how regulators and payers treat an oral option against established injectables, is the open question.

Generated by AI for reference only.

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