Eli Lilly is wasting no time pursuing the next indication for its newly named obesity drug Foundayo, releasing new data on diabetes on Thursday that could also satisfy the FDA’s request for more safety information on oral GLP-1.
The results seen with Foundayo, also known as orforglipron, enabled Lilly’s late-stage Achieve-4 study to meet its primary endpoint. Specifically, the drug demonstrated non-inferiority to insulin glargine in adults with type 2 diabetes and obesity or overweight who are at high cardiovascular risk.
Professor Lilly said in a press release on April 16 that the risk of major cardiovascular events (MACE), such as cardiovascular death, heart attack, stroke, or hospitalization due to unstable and sudden chest paint, was 16% lower in the trial’s Foundayo cohort compared to the insulin group.
Meanwhile, Lilly said Foundayo has been shown to be superior to insulin glargine in improving blood sugar levels and weight loss in patients at one year, with benefits lasting throughout the 104 weeks of treatment.
With safety and efficacy successes in hand, the company said it plans to submit the drug to the FDA for an approval verdict for type 2 diabetes by the end of the second quarter and once again take advantage of the new Secretary’s National Priority Review Voucher Program.
Foundayo’s reduced MACE risk, which was the study’s primary non-inferiority goal, may help ease the FDA’s desire for additional safety information on the drug, as stated in Foundayo’s approval letter (PDF) issued earlier this month when it was greenlit for obesity.
In the letter, the regulators specifically asked Lilly to gather more data on the drug’s potential association with MACE and drug-induced liver injury, as well as further information on delayed gastric emptying associated with Foundayo and its potential effects in breastfeeding women.
The Agency selected the Achieve-4 study as the appropriate vehicle to provide the necessary MACE data.
Professor Lilly noted that although the trial did not control for multiplicity, the risk of all-cause mortality was also “significantly lower” in the Foundayo and insulin glargine groups. Additionally, the company said its study included a “thorough analysis of the potential for drug-induced liver injury” and that analysis confirmed “no safety signals for the liver, consistent with all previous studies in the ACHIEVE and ATTAIN programs.”
Lilly boasted that Achieve-4 is Foundayo’s “largest and longest-running study” in type 2 diabetes to date. The trial enrolled more than 2,700 patients from 15 countries.
“Through seven Phase 3 trials enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile,” Thomas Seck, MD, SVP of Product Development at Lilly Cardiometabolic Health, said in a statement Thursday.
He added: “ACHIEVE-4 adds a new dimension to that evidence of cardiovascular safety and the observed reduction in all-cause mortality risk in patients at high cardiovascular risk.”
Apart from the MACE risk reduction observed with Foundayo, Lilly Medicine also demonstrated clinically meaningful improvements from baseline in multiple cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and high-sensitivity C-reactive protein (hsCRP), a marker of inflammation.
Foundayo’s FDA agreement on April 1 officially opens a new front in the ongoing obesity and broader GLP-1 commercial contest between Lilly and Novo Nordisk. Until now, that competition has been between the company’s respective injectable drugs for diabetes and obesity. For Lily, these are Mounjaro and Zepbound, and for Novo, they are Ozempic and Wegovy.
Novo edged out Lilly with the approval of its oral weight-loss drug, Wigovy tablets, in late 2025, and subsequently launched it on January 5th, with impressive results so far.
Lilly hopes the fact that the tablets can be taken at any time of the day and without food or water restrictions will give Foundayo a convenience advantage over oral Wigovy, which must be taken on an empty stomach in the morning with up to 4 ounces of water rather than other liquids.
