Eli Lilly said its oral obesity drug Foundayo met the main goal of a cardiovascular outcomes study in people with diabetes, showing no greater risk of heart attacks and other cardiovascular events than long-acting insulin. The company also reported no greater liver harm, with it hinting at possible reductions in death risk that will require confirmation. Separately, newly disclosed FDA documents show regulators asked Lilly to evaluate liver risk and unexpected serious cardiovascular events in ongoing trials as a condition of approval. The request centers on safety monitoring in the Achieve-4 outcomes trial and submission timelines in coming months. Lilly’s diabetes filing strategy is designed to extend the commercial battle with Novo Nordisk’s GLP-1 franchise. Together, the efficacy readout and the FDA’s liver-focused follow-up indicate that “cardiometabolic benefit” is no longer the only hurdle—ongoing safety evidence will shape labeling and uptake in both obesity and diabetes.