Eli Lilly's Foundayo Cuts Death Risk 57% and Matches Insulin in Trial
Eli Lilly's ACHIEVE-4 trial showed its obesity pill Foundayo achieved matching insulin glargine efficacy in preventing major cardiovascular events over two years in 2,700 high-risk type 2 diabetes patients. The trial also reported a 16% reduction in major adverse events and 57% drop in all-cause mortality, supporting a Q2 label expansion filing.
1. ACHIEVE-4 Trial Efficacy
Foundayo matched insulin glargine in preventing major cardiovascular events including heart attacks and strokes over approximately two years in more than 2,700 high-risk type 2 diabetes and obesity patients, demonstrating non-inferiority in key endpoints.
2. Survival Benefits and Safety Profile
The study showed a 16% lower risk of major adverse cardiovascular events and a 57% reduction in all-cause death compared to insulin glargine, while 11% of participants discontinued treatment due to side effects consistent with earlier trials.
3. Regulatory Strategy and Market Positioning
Following FDA approval with a post-marketing requirement for cardiovascular data, Lilly plans a Q2 submission for label expansion under accelerated review, aiming to broaden Foundayo’s use into diabetes and strengthen its competitive stance against injectable GLP-1 therapies.