Eli Lilly reported positive top-line results from a cardiovascular outcomes trial of Foundayo (orforglipron), meeting the study’s heart safety objective versus insulin glargine in adults with type 2 diabetes and obesity or overweight. Lilly said the trial demonstrated non-inferiority for major adverse cardiovascular events (MACE), with similar cardiovascular risks between Foundayo and insulin. The company also reported no greater risk of liver harm compared with insulin, addressing specific post-approval requirements. Lilly indicated it will submit Foundayo to the FDA as a treatment for type 2 diabetes by the end of the second quarter, using a national priority review voucher. Regulatory action in diabetes would broaden the commercial arena beyond obesity. Separately, analysis circulating in the dataset points to an additional finding of reduced all-cause mortality versus insulin, though Lilly framed it as a signal needing further confirmation.