Eli Lilly’s oral obesity drug Foundayo (orforglipron) cleared an important cardiovascular safety milestone in people with diabetes, meeting the main goal of non-inferiority to insulin glargine for major adverse cardiovascular events (MACE). Lilly said the pill was also not associated with greater risk of liver harm versus insulin, fulfilling an FDA post-marketing requirement. Separately, FDA documents show the agency is requiring Lilly to continue evaluating liver safety as a condition of approval. The regulator’s letter asks Lilly to analyze unexpected liver-enzyme elevations and liver-related serious events in ongoing trials, alongside further cardiovascular safety reporting tied to Achieve-4. Together, the updates extend Foundayo’s clinical path beyond weight loss into broader risk management—an area that could influence uptake as the oral GLP-1 competitive field intensifies.