Eli Lilly reported positive cardiovascular safety results for Foundayo (orforglipron) in a Phase III outcomes trial in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. In Achieve-4, the pill met the trial’s primary “non-inferior” major adverse cardiovascular events (MACE) endpoint versus insulin glargine. Lilly also said no greater risk of liver injury was observed versus insulin, fulfilling a post-marketing requirement tied to the FDA’s obesity approval pathway. The company plans to seek FDA authorization in type 2 diabetes by the end of the second quarter, leveraging a national priority review voucher. The readout matters because it expands the opportunity for oral incretin-based competition beyond injectable GLP-1 therapies, while meeting a key regulator hurdle for chronic cardiovascular risk reduction. It also increases pressure on competitors as payers and prescribers evaluate oral options for broader metabolic indications.