Eli Lilly announced that its new obesity pill, which had received approval, was not inferior to a commonly used long-acting insulin in reducing the risk of serious heart issues in patients with type 2 diabetes and obesity.
The Pill, Foundayo, which Lilly plans to use to lose weight, was approved by the U.S. Food and Drug Administration earlier this month, boosting the competition between the two pharmaceutical giants Lilly and Danish competitor Novo Nordisk, whose own oral Wegovy has been available since January.
The late-stage study results also contribute to the obesity drug’s potential in diabetes, which will enhance Lilly’s standing in the multi-billion-dollar market, with drugmakers competing to develop more convenient oral forms as an alternative to injectables.
Lilly stated that it would request the United States to approve Foundayo for type 2 diabetes under the Commissioner in the National Priority Review Voucher, which is designed to expedite FDA reviews of drugs that are considered of high priority to the health or even national security. It will file an application by the second quarter, the company added.
The trial of 2,700 patients, who were at increased cardiovascular risk, showed that Foundayo lowered the risk of heart attack, stroke or cardiovascular death by 16%, when compared with those on insulin glargine. The drug reduced the mortality rate of any cause by 57%.
Foundayo also contributed to the bettering of the A1C levels of patients – the average level of sugar in the blood over the last few months – and their body weight at 52 weeks.
Insulin glargine (Lantus by Sanofi and Basaglar by Lilly) is a long-acting, synthetic insulin, to be used in managing the blood sugar of patients with type 1 and type 2 diabetes. The FDA had requested Lilly to conduct more post-marketing studies and provide more data regarding the liver injury of Foundayo.
Lilly reported that the trial involved an examination of possible liver damage as well, and there were no liver safety concerns, as was previously reported. All this data should help to dispel any worries that Foundayo is exposed to any special liver safety risks compared to competitors such as oral Wegovy, according to RBC Capital Markets analyst Trung Huynh.
Lilly Study Highlights Cardiovascular Benefits
According to a late-stage clinical trial conducted by Lilly, Foundayo reduced the combined risk of heart attack, stroke, and cardiovascular death by approximately 16% compared to standard insulin therapy.
The study involved over 2,700 high-risk patients with type 2 diabetes and obesity, making it one of the most comprehensive evaluations of an oral GLP-1 therapy by Lilly.
These findings position Lilly’s Foundayo as a competitive alternative to injectable treatments, especially for patients seeking convenient oral options.
The therapy works by mimicking incretin hormones that regulate blood sugar and appetite. By enhancing insulin secretion while reducing glucagon levels, it helps maintain stable glucose control. At the same time, it slows gastric emptying, which contributes to weight loss and improved metabolic balance.
These combined effects are particularly important because cardiovascular risk is closely tied to metabolic health. By addressing multiple pathways at once, the treatment provides a more comprehensive approach to reducing long-term complications.
Patient Adherence and Real-World Benefits
One of the most significant advantages of an oral therapy is improved patient adherence. Many individuals are reluctant to start or continue injectable treatments, which can lead to inconsistent use and suboptimal outcomes.
A once-daily tablet simplifies treatment routines and may lead to better long-term compliance. In real-world settings, this convenience could translate into fewer hospitalizations and reduced healthcare costs.
Comparison With Existing Therapies
Current standard treatments for cardiometabolic conditions often require a combination of medications, including injectables. While effective, these regimens can be complex and burdensome for patients.
