Eli Lilly aims for 2027 filing for obesity drug retatrutide
The drugmaker said two more late-stage trials showed weight loss and blood sugar benefits in adults with obesity and major complications.
By Frankie Delgado · News Reporter
3 min read
Eli Lilly now plans to seek approval for retatrutide, its experimental weekly obesity shot, in the first quarter of 2027 after the drug succeeded in two additional late-stage studies, the company said Thursday.
The timing is later than Lilly had previously signaled. The drugmaker had said it could submit the treatment for approval as early as this year, but told CNBC it needs more time to collect and verify manufacturing and quality-control information required by regulators.
Retatrutide is being watched closely because Lilly says the medicine works differently from today’s leading weight-loss treatments. In the latest phase three trials, the company said the drug produced weight loss and improved a key blood sugar measure in adults with obesity who also had Type 2 diabetes or established cardiovascular disease.
Kenneth Custer, president of Lilly Cardiometabolic Health, said in a company release that Lilly believes the results give it the data needed to pursue global approval for retatrutide as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea.
What the trials showed
In one late-stage trial involving adults with obesity and Type 2 diabetes, patients taking retatrutide lost as much as 20.8% of their body weight on average after 80 weeks, according to Lilly. The company said that amounted to nearly 50 pounds.
In a separate trial of adults with severe obesity and established cardiovascular disease, with or without diabetes, patients on the drug lost up to 22.6% of their body weight on average after 80 weeks, Lilly said. The company put that figure at 55.8 pounds.
Lilly also said retatrutide meaningfully lowered certain cardiovascular risk factors in the cardiovascular disease study. The company did not report unexpected safety signals in the summary released Thursday.
The side effects Lilly identified were in line with earlier retatrutide studies and with the broader GLP-1 drug class. The company said the most common side effects included diarrhea, nausea and constipation.
A three-pronged shot
Retatrutide has been nicknamed a “triple G” drug because it targets three hormone pathways: GLP-1, GIP and glucagon. Lilly says that approach appears to have stronger effects on appetite and feelings of fullness than existing drugs that target one or two of those pathways.
Lilly’s Zepbound contains tirzepatide, which mimics GLP-1 and GIP. Novo Nordisk’s Wegovy contains semaglutide, which mimics GLP-1.
The new results bring retatrutide to five positive late-stage trials, according to Lilly. The company is positioning the drug as a major part of its obesity business alongside Zepbound and its newly launched pill, Foundayo.
Wall Street is already sizing up the possible payday. TD Cowen analysts estimated in a January note cited by CNBC that retatrutide could generate $3.8 billion in sales in 2030.
The stakes are high for Lilly as it competes with Novo Nordisk in the fast-growing market for weight-loss and diabetes drugs. CNBC reported that some analysts estimate the category could reach about $100 billion by the 2030s.
This story draws on original reporting from CNBC.