Eli Lilly reports Foundayo met primary objective in Phase 3 ACHIEVE-4 study

Eli Lilly (LLY) and Company announced topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo, compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries. In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events, including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. In addition, Foundayo showed superior improvements in A1C and body weight at 52 weeks vs. insulin glargine, which persisted through 104 weeks of therapy. While not controlled for multiplicity, the risk of all-cause death was significantly lower for Foundayo vs. insulin glargine. “Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile,” said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. “ACHIEVE-4 adds a new dimension to that evidence – cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes.” In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain was 16% lower for Foundayo vs. insulin glargine, meeting the prespecified criteria for demonstrating non-inferiority. The risk of all-cause death was 57% lower with Foundayo vs. insulin glargine. Foundayo also showed clinically meaningful improvements from baseline across several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP. The overall safety and tolerability profile of Foundayo in ACHIEVE-4 was generally consistent with previous trials and with the GLP-1 class. The most common adverse events for patients taking Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of patients taking Foundayo discontinued treatment due to adverse events. ACHIEVE-4 included a thorough analysis of potential drug-induced liver injury, and these analyses confirmed there was no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs. Lilly will submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of the second quarter under the Commissioner’s National Priority Review Voucher.