Eli Lilly disclosed that its Phase 3 ACHIEVE‑4 trial for the oral GLP‑1 drug Foundayo (orforglipron) met its primary endpoint by demonstrating non‑inferiority to insulin glargine for major adverse cardiovascular events (MACE‑4). The 2,749‑patient, 15‑country study reported a hazard ratio of 0.84 (95 % CI 0.59–1.20), translating to a 16 % lower risk of MACE‑4 and a 57 % lower risk of all‑cause death, with no new liver safety signals.
Foundayo received FDA approval for obesity on April 1 2026, and Lilly plans to submit a diabetes indication by the end of the second quarter of 2026. The cardiovascular safety data address long‑standing concerns about GLP‑1 therapies and position Foundayo as a strong candidate for a broader indication that could capture a larger share of the growing diabetes market.
The trial’s results give Lilly a competitive advantage over Novo Nordisk’s oral Wegovy, which was approved in December 2025 and has faced scrutiny over cardiovascular outcomes. While Wegovy achieved 16–17 % weight loss versus placebo, Foundayo’s average weight loss of 11 % is lower, but its superior cardiovascular safety profile and oral convenience—no food or water restrictions—could make it a preferred option for patients and payers.
The findings strengthen Lilly’s cardiometabolic portfolio and could accelerate adoption and revenue growth. By demonstrating a significant reduction in all‑cause mortality, Foundayo differentiates itself from other GLP‑1 agents and supports Lilly’s strategy to expand its presence in both obesity and diabetes markets.
The trial also confirms that Foundayo’s small‑molecule design delivers a robust safety profile, with no new liver signals observed across 2,749 participants. This safety assurance, combined with the drug’s oral administration, positions Lilly to capitalize on the growing demand for convenient, effective cardiometabolic therapies.
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