Lilly, with new data, to seek FDA approval of obesity drug retatrutide

An article from Obesity drugs Lilly, with new data, to seek FDA approval of obesity drug retatrutide The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health. Published July 23, 2026 By Kristin Jensen Share Copy link Email LinkedIn X/Twitter Facebook Print License Add us on Google Dive Brief: Eli Lilly on Thursday bolstered the case for its new experimental obesity medicine, announcing the success of two more Phase 3 trials and plans to seek approval of the drug next year. The Triumph-2 and Triumph-3 studies build on research released in May that found the drug, retatrutide, could help people lose 30% of their body weight after 104 weeks, reaching a level associated with bariatric surgery. The two new trials included overweight or obese patients who also had either type 2 diabetes or cardiovascular disease. The overall weight loss in the two studies was less than in the Triumph-1 study released in May, showing an average of 21% body weight loss after 80 weeks in the diabetes group and 23% loss in the cardiovascular disease cohort at the highest doses. Still, those results met expectations for patients with underlying conditions who often lose less weight, RBC Capital Markets analyst Trung Huynh wrote in a note to clients. Dive Insight: Lilly aims to be the first drugmaker to offer a new approach in the increasingly crowded obesity treatment market. Retatrutide is designed to super charge weight loss by activating three hormone receptors, GLP-1, GIP and glucagon. By contrast, Novo Nordisk’s Ozempic/Wegovy medicine works on GLP-1, and Lilly’s Mounjaro/Zepbound focuses on GLP-1 and GIP. The results have been impressing researchers and investors for years, and the promise of retatrutide has drawn extraordinary attention. Some patients have resorted to purchasing it on the black market, and when a published report from Stat News revealed that one 79-year-old patient got special access to the drug in April, lawmakers pressed U.S. officials to find out if that person was President Donald Trump. Lilly has seen great success with its market-leading injectable tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity. The drug recently became the best-selling medicine in the world and propelled Lilly to become the first pharmaceutical company worth more than $1 trillion. But retatrutide would enter a market with multiple effective options and that’s recently been shaken up by the arrival of oral alternatives, Novo’s Wegovy pill and Lilly’s Foundayo. Other companies including Pfizer, Kailera Therapeutics and Amgen are vying to improve on the class, too. And while retatrutide has shown powerful weight loss results, it also appears to come with more side effects, which, to some analysts, might limit its use to patients who have the most weight to lose. For the most part, patients who experienced side effects while taking retatrutide reported symptoms such as diarrhea, nausea, constipation and vomiting. But analysts are paying close attention to its impact on heart health. While Lilly’s studies weren’t designed to definitively prove whether retatrutide could lower the risk of heart attacks or strokes, investigators nonetheless tracked the drug’s impact on these kinds of outcomes. In the treament group in the Triumph-3 study, for instance, there were 27 “MACE-3” events — cardiovascular deaths, heart attacks or strokes — compared to 23 in the placebo group. Another measure, “MACE-5,” which includes all-cause death, heart attack, stroke, heart failure and instances of a kind of cardiovascular medical procedure, favored the treatment group over placebo in that study. In its press release, Lilly mentioned that these events occurred less frequently than it had expected. And the relatively small sample size and follow-up time makes it “difficult to draw solid conclusions at this point,” William Blair analyst Andy Hsieh said in a note to clients. One possibility is that the placebo group patients were using a weight-loss drug “off-record,” he wrote. Earlier this year, Lilly included retatrutide in a group of medicines that might be slated for regulatory submission by the end of 2026. But the company now says it’s set for a Food and Drug Administration application in the first quarter of next year. Lilly told CNBC it needed more time to gather manufacturing and quality-control data for the agency. Add us on Google Share Copy link Email LinkedIn X/Twitter Facebook Print License Filed Under: FDA, Clinical Trials