New FDA documents show Eli Lilly has been asked to evaluate liver and cardiovascular risks for its recently approved obesity pill Foundayo as part of ongoing trials, following approval conditions. The request targets unexpected serious heart-attack risk signals and liver injury signals, including elevated liver enzymes and liver-related discontinuations. The documents cite requirements tied to Lilly’s diabetes outcomes work, including the Achieve-4 study, with investigators due to wrap up this month and submit results to the FDA in July. Lilly said no hepatic safety signals have been observed across the Phase 3 program to date. The FDA’s move comes as competition intensifies in the oral GLP-1 market, with Novo Nordisk’s Wegovy already on the US market after earlier approval.