Lilly’s Foundayo earns non-inferiority and cardiometabolic gains in ACHIEVE-4, fueling FDA submission
In ACHIEVE-4, the largest/longest Phase 3 trial of Foundayo (orforglipron) vs insulin glargine in adults with type 2 diabetes at high CV risk, Foundayo met non-inferiority for MACE-4 and showed 16% lower risk for MACE-4 and 23% lower risk for MACE-3; a pre-planned analysis also showed 57% lower risk of all-cause death. The study (2,700+ participants across 15 countries) demonstrated sustained A1C and body-weight improvements through 104 weeks. Lilly intends to submit Foundayo to the FDA for type 2 diabetes by end of Q2.