Lilly's Foundayo matches insulin
Lilly reported that its oral obesity pill Foundayo (orforglipron) was non‑inferior to long‑acting insulin glargine for reducing major cardiovascular events in people with type 2 diabetes and obesity in the ACHIEVE‑4 trial. (reuters.com) Reuters and Clinical Trials Arena reported the FDA still requires post‑marketing studies to monitor “unexpected serious” risks despite ACHIEVE‑4 addressing several safety questions. (clinicaltrialsarena.com)
Eli Lilly said on April 16 that Foundayo, its once-daily obesity pill, matched insulin glargine on cardiovascular safety in a late-stage diabetes trial. (investor.lilly.com) The Phase 3 ACHIEVE-4 study enrolled 2,749 adults across 15 countries with type 2 diabetes and obesity or overweight plus elevated cardiovascular risk, and compared oral orforglipron with long-acting insulin glargine over about two years. (clinicaltrials.gov; investor.lilly.com) A cardiovascular safety trial asks a basic question before anything else: does a new drug raise the odds of heart attack, stroke or cardiovascular death. Lilly said ACHIEVE-4 met that bar, with a hazard ratio of 0.84 and an upper confidence-limit below the trial’s non-inferiority threshold of 1.8. (investor.lilly.com) Lilly also said Foundayo beat insulin glargine on blood-sugar control and weight at 52 weeks, with benefits that persisted through 104 weeks. In a pre-planned analysis, the company reported a 57% lower risk of all-cause death, though it said that result was not controlled for multiplicity. (investor.lilly.com) The result matters for a simple reason: Foundayo is a pill in a market dominated by injectable diabetes and obesity drugs. Lilly said the tablet has no food or water restrictions, a detail the company is using to argue for easier day-to-day use than injections. (investor.lilly.com) It also arrives days after the Food and Drug Administration approved Foundayo for chronic weight management in adults with obesity, or overweight plus at least one weight-related condition. The approval letter is dated April 10, 2026. (accessdata.fda.gov) That approval did not end the safety review. The Food and Drug Administration told Lilly to run postmarketing studies on “unexpected serious” risks, including cardiovascular events, drug-induced liver injury, and medullary thyroid carcinoma, according to the approval letter and reporting on it. (accessdata.fda.gov; clinicaltrialsarena.com) Clinical Trials Arena reported the agency also wants follow-up in pregnant patients and in children ages 6 to under 12, plus a 15-year effort to gather more data on thyroid cancer incidence. Lilly’s medical information page said those requirements were part of the approval process for a newly approved medicine. (clinicaltrialsarena.com; medical.lilly.com) Lilly said the ACHIEVE-4 data will support a U.S. filing for type 2 diabetes by the end of the second quarter of 2026. The next test is whether regulators treat the trial as enough to widen Foundayo’s label while the longer safety studies continue in the background. (investor.lilly.com; clinicaltrialsarena.com)
