Eli Lilly’s Foundayo has had a busy few weeks. The FDA approved the weight-loss pill on April 1, and now new clinical trial data is giving investors even more to think about.
A late-stage trial of more than 2,700 adults found that patients taking Foundayo had a 16% lower risk of heart attack, stroke, or cardiovascular death compared to those on insulin glargine — a standard long-acting insulin used for type 1 and type 2 diabetes.
The drug also cut the risk of death from any cause by 57%. That’s a number that tends to get people’s attention.
Eli Lilly and Company, LLY
The trial focused on adults who had type 2 diabetes and were obese, with elevated cardiovascular risk. Foundayo also improved A1C levels — a measure of average blood sugar over several months — and reduced body weight at 52 weeks. Patients on insulin glargine, meanwhile, actually gained weight.
Lilly said the trial met its main goals and the company will now seek FDA approval of Foundayo for the treatment of type 2 diabetes, using the Commissioner’s National Priority Review Voucher to speed up the process. The application is expected before the end of Q2 2026.
One hurdle the drug has faced is the FDA’s request for more data on potential liver injury. The latest trial included an analysis on that front and found no liver safety concerns — a result consistent with earlier studies.
RBC Capital Markets analyst Trung Huynh said the data should allay fears that Foundayo faces unique liver safety risks compared to competitors like Novo Nordisk’s oral Wegovy, which has been on the market since January.
That’s a meaningful development. Novo Nordisk entered the oral obesity market first, and any lingering safety questions about Foundayo could have weighed on its commercial potential.
The cardiovascular results add to an already expanding profile for the drug. Earlier trials found potential benefits in areas ranging from high blood pressure to alcohol addiction.
Peak annual sales for Foundayo are projected to reach $36 billion, according to Wall Street estimates.
LLY stock gained 0.86% on the day the data was released. The stock carries a consensus Strong Buy rating from 19 Wall Street analysts — 16 Buy, 2 Hold, and 1 Sell — with an average price target of $1,247.38, implying roughly 31.5% upside from current levels.
The diabetes application is expected to be submitted by end of Q2 2026.
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