Eli Lilly’s oral obesity drug Foundayo (orforglipron) cleared key cardiovascular safety scrutiny in the Phase 3 Achieve-4 trial in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. Lilly reported that the trial met its primary endpoint of non-inferiority for major adverse cardiovascular events versus insulin glargine. Separately, newly disclosed FDA follow-up requests require Lilly to evaluate liver-safety signals in Achieve-4 and to submit related analyses. The agency’s stipulation centers on unexpected elevated liver enzymes and related discontinuations, alongside cardiovascular risk assessment tied to the ongoing outcomes work. Together, the updates sharpen attention on how quickly Foundayo can expand beyond obesity into diabetes and how regulators may frame comparative safety evidence as the oral GLP-1 field intensifies competition.