Foundayo ACHIEVE-4: MACE-4 non-inferiority met vs insulin glargine, not significant

Lilly reported detailed ACHIEVE-4 results for Foundayo on September 30, 2026, showing the oral GLP-1 met non-inferiority against insulin glargine on major adverse cardiovascular events. The point estimates favored Foundayo but the confidence intervals include no difference, and the all-cause death result was a non-multiplicity-adjusted pre-planned analysis. The data support the cardiovascular safety profile needed for the type 2 diabetes filing.

• MACE-4 hazard ratio 0.84 (95% CI 0.59-1.20); non-inferiority met
• MACE-3 hazard ratio 0.77 (95% CI 0.52-1.13); not statistically significant
• All-cause death hazard ratio 0.43 (95% CI 0.25-0.75), pre-planned and not multiplicity-adjusted
• 2,749 participants; 10.6% of Foundayo patients discontinued for adverse events