Foundayo obesity pill matches insulin in heart study

Eli Lilly reported that its weight‑loss pill Foundayo performed at least as well as an older insulin at preventing major cardiovascular events in a late‑stage trial of patients with diabetes and obesity; the FDA has asked Lilly to submit the trial data by July as part of a safety review.

Eli Lilly said its new weight‑loss pill Foundayo performed at least as well as an older insulin at preventing heart attacks, strokes and other major cardiovascular events. The late‑stage trial compared Foundayo to Lilly's insulin and followed patients for about two years. The study focused on people who had both diabetes and obesity and who were at increased cardiovascular risk. The result comes after the US Food and Drug Administration asked Lilly for more safety data and required the company to submit the trial data by July. Lilly said the trial included a thorough liver analysis and found no sign the pill is unsafe. Key findings: - Lilly reported Foundayo was at least as effective as an older insulin at preventing major cardiovascular events in the trial. - The late‑stage study compared Foundayo to Lilly's insulin and followed participants for about two years. - The trial population included people with both diabetes and obesity who were at increased cardiovascular risk. - The FDA requested additional safety data and set a deadline for Lilly to submit the trial data by July. - Lilly said the trial included a detailed liver analysis and found no liver safety signal. - The FDA cleared Foundayo about two weeks earlier under an expedited program, and Lilly shares fell about 1.9% after the agency's request for more data. Summary: Lilly said the trial results should help alleviate concerns about Foundayo's effects on patients' hearts. The drug received FDA clearance under an expedited program two weeks ago. The next procedural step is Lilly's submission of the requested trial data to the FDA by July.