Eli Lilly said its oral GLP-1 receptor agonist Foundayo (orforglipron) met the primary goal of a cardiovascular outcomes safety test in people with diabetes and obesity, showing no greater risk of major adverse cardiovascular events versus insulin glargine. Lilly also reported no added liver-harm risk versus insulin, fulfilling an FDA post-approval requirement. In a separate disclosure, the FDA asked Lilly to continue evaluating liver safety in ongoing trials, including to analyze unexpected liver-enzyme elevations that meet prespecified criteria and to submit requested data for “unexpected serious risk” outcomes. Lilly is preparing a diabetes submission using a National Priority Review Voucher. The twin moves—heart safety clearance plus follow-on liver-risk evidence—shape how quickly Foundayo can broaden beyond weight loss into diabetes, where Lilly expects renewed competitive pressure on GLP-1 franchises.