Foundayo Demonstrates Cardiovascular Safety and Sustained Metabolic Benefits in Lilly’s ACHIEVE-4 Trial

Eli Lilly reported that its Phase 3 ACHIEVE-4 trial found the oral GLP‑1 receptor agonist Foundayo (orforglipron) to be cardiovasculary safe and to produce lasting reductions in HbA1c, body weight, and other cardiometabolic markers in adults with type 2 diabetes who also have obesity or overweight.

Individuals with type 2 diabetes are at heightened risk for cardiovascular events, so effective glucose control and cardiovascular protection are key therapeutic objectives.

The ACHIEVE-4 trial was designed to assess whether Foundayo could deliver metabolic improvements without compromising cardiovascular safety.

Representing the largest and longest evaluation of Foundayo in type 2 diabetes to date, ACHIEVE‑4 compared the drug against titrated insulin glargine in patients with type 2 diabetes, obesity or overweight, and elevated cardiovascular risk.

Lilly stated that the trial achieved its primary endpoint, showing non‑inferiority for major adverse cardiovascular events. Participants receiving Foundayo had a 16% reduction in the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina (MACE‑4) and a 23% reduction in MACE‑3 (cardiovascular death, heart attack, or stroke) versus those on insulin glargine.

Pre‑specified analyses revealed a 53% decrease in cardiovascular mortality and a 57% reduction in all‑cause mortality for Foundayo‑treated patients relative to insulin glargine.

The company further noted durable declines in HbA1c and body weight, along with favorable shifts in multiple cardiometabolic risk indicators, underscoring Foundayo’s potential utility for type 2 diabetes patients who carry heightened cardiovascular risk.

Foundayo is a once‑daily oral GLP‑1 receptor agonist that can be taken without regard to meals or water intake. Lilly suggests that the ease of an oral formulation could expand access to GLP‑1 therapy for patients who prefer to avoid injections.

Having secured U.S. approval for chronic weight management in April 2026, Foundayo produced $98 million in revenue during Q2 2026 and continues to be investigated for type 2 diabetes and additional cardiometabolic indications.

The ACHIEVE‑4 results were unveiled at the EASD 2026 conference in Milan, Italy, and concurrently published in The Lancet. Lilly is advancing Foundayo throughout its wider cardiometabolic development pipeline.

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