Overview
- ACHIEVE-4, reported Thursday, found Foundayo noninferior to insulin glargine for major cardiovascular events in 2,749 adults with type 2 diabetes at high cardiovascular risk.
- Patients on the once-daily oral GLP-1 pill saw larger drops in HbA1c and greater weight loss at 52 weeks than those on insulin glargine.
- A preplanned analysis linked Foundayo to a 57% lower risk of death from any cause versus insulin glargine, and Lilly said this finding was not adjusted for multiple comparisons.
- Safety findings were consistent with the GLP-1 class, with nausea and other GI effects common, a 10.6% discontinuation rate, and no signs of drug‑induced liver injury in the trial.
- The FDA, which cleared Foundayo for weight management on April 1, is requiring post‑marketing studies including pediatric and pregnancy research, an ultrasound study of gastric emptying, and 15‑year thyroid monitoring as Lilly pursues a diabetes label.