Eli Lilly plans 2027 retatrutide filing after two obesity trial wins
Eli Lilly said retatrutide met goals in two late-stage studies, but the company now expects to seek approval in early 2027.
By Daniel Okafor · Business Editor
3 min read
Eli Lilly said Thursday that it plans to seek regulatory approval for retatrutide, its next-generation obesity injection, in the first quarter of 2027 after the drug succeeded in two more late-stage trials. The timing matters for the fast-growing weight-loss drug market because Lilly is positioning retatrutide as a follow-on to Zepbound and its newly launched pill, Foundayo, according to CNBC.
The company had previously indicated that it could submit the weekly treatment for approval as soon as this year, CNBC reported. In a statement to CNBC, Lilly said it needs additional time to collect and verify manufacturing and quality-control information required by regulators.
In the two phase 3 studies, Lilly said retatrutide produced substantial weight loss and improved a key blood-sugar measure in adults with obesity who also had either Type 2 diabetes or established cardiovascular disease. The company said the latest results add to earlier positive late-stage findings for the drug.
Trial results
In one study, adults with obesity and Type 2 diabetes who received retatrutide lost as much as 20.8% of their body weight on average after 80 weeks, Lilly said. CNBC reported that the reduction amounted to nearly 50 pounds, and noted that people in that patient group often have a harder time losing weight.
In a separate trial, adults with severe obesity and established cardiovascular disease lost as much as 22.6% of their body weight on average after 80 weeks, according to Lilly. CNBC reported that the average reduction was 55.8 pounds and that the study included patients with and without diabetes.
Lilly said retatrutide also lowered certain cardiovascular risk factors in the cardiovascular-disease trial. The company did not report a new safety signal in the results cited by CNBC, saying side effects were in line with previous retatrutide studies.
The most common side effects included diarrhea, nausea and constipation, according to Lilly. CNBC noted that those gastrointestinal side effects are also common across the broader GLP-1 class of drugs.
How the drug fits Lilly’s portfolio
Retatrutide targets three hormone pathways: GLP-1, GIP and glucagon, CNBC reported. Current treatments generally act on one or two of those targets, including tirzepatide, the active ingredient in Lilly’s Zepbound, which mimics GLP-1 and GIP.
Novo Nordisk’s Wegovy uses semaglutide, which mimics GLP-1, according to CNBC. Retatrutide’s three-target approach has led analysts and investors to watch whether it can produce stronger effects on appetite and fullness than existing medicines.
Kenneth Custer, president of Lilly Cardiometabolic Health, said in a company release that Lilly believes the data package can support global filings for retatrutide as a potential treatment for obesity, knee osteoarthritis pain and obstructive sleep apnea, according to CNBC.
CNBC reported that retatrutide now has positive results from five late-stage trials. TD Cowen analysts estimated in a January note cited by CNBC that the drug could generate $3.8 billion in sales in 2030.
The drug is part of Lilly’s effort to keep a leading position against Novo Nordisk in weight-loss and diabetes medicines, CNBC reported. Some analysts estimate that market could reach about $100 billion by the 2030s.
This story draws on original reporting from CNBC.