Lilly's Foundayo obesity pill reduces cardiovascular risk in late-stage trial

A late-stage trial of more than 2,700 adults found Foundayo lowered the risk of major cardiovascular events by 16% and all-cause death by 57% versus insulin glargine; Lilly plans to submit a U.S. approval application by the end of the second quarter.

Eli Lilly reported results from a long late-stage trial of its newly approved obesity pill, Foundayo, in adults with type 2 diabetes and obesity. The company said the study met its main goal by showing comparable or improved cardiovascular outcomes versus insulin glargine. The trial enrolled more than 2,700 adults. Lilly also reported differences in blood sugar and weight changes between the two groups after one year. Key trial findings: - The study included more than 2,700 adults with type 2 diabetes and obesity. - Patients taking Foundayo had a 16% lower risk of heart attack, stroke or cardiovascular death compared with those on insulin glargine, as reported by Lilly. - Patients on Foundayo had a 57% lower risk of death from any cause compared with the insulin glargine group, according to the company. - After one year, patients taking Foundayo showed larger reductions in blood sugar and weight, while those on insulin glargine gained weight, per Lilly's announcement. - Lilly said it will seek U.S. approval of Foundayo for type 2 diabetes using a Commissioner's National Priority Review Voucher and expects to submit an application by the end of the second quarter. Summary: The trial results reported by Lilly show lower rates of major cardiovascular events and all-cause mortality in the Foundayo group compared with insulin glargine, along with greater reductions in blood sugar and weight over one year. Lilly has announced plans to pursue U.S. regulatory approval and to submit an application by the end of the second quarter.