Eli Lilly Foundayo Results

Eli Lilly said April 16 that its diabetes pill Foundayo met the main safety goal in a late-stage trial against insulin glargine. (investor.lilly.com) In ACHIEVE-4, Lilly said Foundayo, also called orforglipron, was tested in more than 2,700 adults across 15 countries with type 2 diabetes, obesity or overweight, and elevated cardiovascular risk. The study followed patients for up to 104 weeks, making it Lilly’s longest Foundayo trial in diabetes so far. (investor.lilly.com) The company said the pill showed a 16% lower risk of major cardiovascular events than insulin glargine on the broader MACE-4 measure, with a hazard ratio of 0.84, meeting the preset noninferiority bar rather than proving superiority. Lilly also reported a 23% lower risk on the narrower MACE-3 measure and a 57% lower risk of all-cause death in a preplanned analysis. (investor.lilly.com) Foundayo is a glucagon-like peptide-1, or GLP-1, pill, a class of medicines that lowers blood sugar and appetite by mimicking a gut hormone. Unlike the older oral GLP-1 Rybelsus, the Food and Drug Administration said Foundayo can be taken once daily without food or water restrictions. (fda.gov) That convenience is central to Lilly’s pitch because the FDA approved Foundayo on April 1 for obesity and overweight with at least one related condition, but not yet for type 2 diabetes. Lilly said after the ACHIEVE-4 readout that it plans to submit Foundayo for the diabetes indication to the FDA by the end of the second quarter. (investor.lilly.com, investor.lilly.com) The FDA’s April 1 approval moved unusually fast under the agency’s Commissioner’s National Priority Voucher pilot. The agency said it cleared Foundayo 50 days after filing and 294 days ahead of the original January 20, 2027 target date. (fda.gov) Lilly has been building the diabetes case for more than a year. In April 2025, the company said an earlier phase 3 trial, ACHIEVE-1, lowered A1C by 1.3% to 1.6% and cut weight by as much as 16 pounds at the highest dose, with a safety profile Lilly said matched injectable GLP-1 drugs. (investor.lilly.com) The new results also address a question hanging over the launch after reports this month that FDA reviewers had asked Lilly for more safety information on several “unexpected serious” events tied to the obesity filing. Fierce Pharma reported April 15 that Lilly was collecting more data while keeping its diabetes submission on track; two days later, Lilly said ACHIEVE-4 reaffirmed the drug’s cardiovascular and overall safety profile. (fiercepharma.com, investor.lilly.com) For Lilly, the next step is no longer whether Foundayo can reach the market in pill form; that happened on April 1. The next test is whether regulators will let the company add type 2 diabetes to the label after a trial designed to show the pill can protect the heart at least as well as a standard insulin comparator. (fda.gov, investor.lilly.com)