The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
Eli Lilly’s newly approved oral obesity drug Foundayo has already run into a speedbump after the FDA detected safety risks affecting the heart and liver—signals that the regulator found serious enough to necessitate a postmarketing clinical trial.
“We have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess” these risks, the agency wrote in its approval letter for Foundayo, issued April 1. The FDA in particular zeroed in on “retained gastric contents” as well as “unexpected” cases of major adverse cardiovascular events and drug-induced liver injury (DILI).
Lilly is already running the Phase 3 ACHIEVE-4 trial of daily Foundayo in patients with type 2 diabetes who are obese or overweight and are at heightened cardiovascular risk. The FDA in its letter asked that the study also assess DILI. ACHIEVE-4’s estimated completion date was last month, and the agency expects a final report by July.
Aside from the cardiovascular and liver assessments, the FDA in its letter asked Lilly to conduct a slew of other postmarketing studies directed at other safety outcomes, including Foundayo’s impact on pregnancy and child development and potential risks of thyroid cancer.
BioSpace has reached out to Lilly for its statement on the matter.
While the FDA classified these signals as “serious,” analysts at BMO Capital Markets told investors in a note on Tuesday that the agency’s requests “appear manageable.” Asking Lilly to run several postmarketing trials is “notable,” the firm conceded, but “we do not expect these studies to have any meaningful impact on the competitive positioning” of Foundayo.
“We view this as a reflection of conservatism from FDA,” BMO analysts continued, framing the requested trials as a positive for Foundayo. “Over time, successful completion of these studies would further de-risk the asset and continue to support broad confidence in oral, small molecule incretin therapies.”
The FDA signed off on Foundayo on April 1, restarting the heated rivalry between Lilly and Novo Nordisk, this time in the oral arena. The Danish drugmaker was first to the field with its Wegovy pill, which the regulator approved late last year, but many analysts expect Foundayo to put up a considerable challenge.
For starters, Foundayo is a small-molecule drug, which is easier and faster to produce that the peptide Wegovy, potentially giving Lilly a step up in supply chain over Novo. The manufacturing advantage “could be potentially influential in the fight for the oral obesity market,” BMO’s Evan Seigerman told BioSpace in August 2025.
Lilly looks poised to press this advantage. Even before Foundayo’s approval, the pharma had prepared a stockpile of the drug worth $1.5 billion, ready for launch. Investors are now turning their focus to the pharma’s first-quarter earnings call on April 30 for updates on how the drug is rolling out, BMO said on Tuesday.