ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries.

In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine.

In addition, Foundayo showed superior improvements in A1C and body weight at 52 weeks vs. insulin glargine, which persisted through 104 weeks of therapy, read a statement issued by Eli Lilly and Company.

While not controlled for multiplicity, the risk of all-cause death was significantly lower for Foundayo vs. insulin glargine.

"Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "ACHIEVE-4 adds a new dimension to that evidence — cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes."

In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain was 16% lower for Foundayo vs. insulin glargine (hazard ratio: 0.84; 95.0% CI: 0.59 to 1.20), meeting the prespecified criteria for demonstrating non-inferiority (upper limit of 95.0% CI of the hazard ratio < 1.8).

The risk of all-cause death was 57% lower with Foundayo vs. insulin glargine (hazard ratio: 0.43; 95.0% CI: 0.25 to 0.75; nominal p = 0.002).

Foundayo also showed clinically meaningful improvements from baseline across several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP.