Eli Lilly reported positive cardiovascular safety results for its oral obesity and diabetes medicine Foundayo (orforglipron), meeting the main goal of a heart safety trial in a phase III program in adults with diabetes and obesity or overweight at increased cardiovascular risk. Lilly said the risk of major adverse cardiovascular events with Foundayo was non-inferior to insulin glargine. The company also reported no greater liver harm signal versus insulin in the post-marketing requirement testing and noted additional exploratory indications, including a potential reduction in all-cause death that would require further confirmation. Lilly said it will seek FDA approval for Foundayo in type 2 diabetes by the end of the second quarter and plans to leverage a national priority review voucher. The update directly affects Lilly’s timing and competitive positioning against other oral incretin strategies and strengthens the evidence package used for regulatory discussions around expanding the product’s label.