The company previously indicated it could seek FDA approval for the triple-hormone drug as early as this year
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Eli Lilly $LLY said Thursday it plans to file for regulatory approval of its next-generation weight loss drug retatrutide in the first quarter of 2027, pushing back a timeline the company had previously indicated could come before the end of this year.
Lilly attributed the postponement to the additional time required to assemble and validate manufacturing and quality-control data that regulators must review before the company can submit an application, according to CNBC.
Lilly made the announcement alongside results from two additional Phase 3 trials showing retatrutide delivered significant weight loss in adults with obesity and two serious complications: type 2 diabetes and established cardiovascular disease.
In the TRIUMPH-2 trial, adults with obesity or overweight and type 2 diabetes taking the 12 mg dose lost an average of 20.8% of their body weight, or roughly 50 pounds, at 80 weeks. Participants on the lower 4 mg and 9 mg doses lost an average of 12.7% and 19.1%, respectively. All three doses also reduced A1C, a key measure of blood sugar control, by up to an average of 1.6 percentage points, the company said.
In the TRIUMPH-3 trial, adults with severe obesity and established cardiovascular disease lost up to an average of 22.6% of their body weight, or about 56 pounds, at 80 weeks on the 12 mg dose. Retatrutide also reduced triglycerides, non-HDL cholesterol, systolic blood pressure, and a marker of inflammation in those patients, Lilly said.
Across both trials, the side-effect profile matched what had been seen in prior retatrutide research, with gastrointestinal complaints — chiefly diarrhea, nausea, and constipation — topping the list, as is typical for GLP-1 medications, the company said.
Kenneth Custer, president of Lilly Cardiometabolic Health, said the accumulated evidence positions Lilly to pursue global regulatory filings for retatrutide covering obesity, knee osteoarthritis pain, and obstructive sleep apnea.
Thursday's results bring the total number of positive late-stage trials for retatrutide to five. Earlier this month full Phase 3 data presented at the American Diabetes Association conference showed participants on the highest dose losing an average of 28.3% of their body weight over 80 weeks, with Lilly Chief Scientific and Product Officer Dan Skovronsky describing that level of weight loss as previously the exclusive territory of bariatric surgery.
Where Zepbound's active ingredient acts on GLP-1 and GIP and Wegovy's targets only GLP-1, retatrutide is engineered to engage all three pathways — GLP-1, GIP, and glucagon simultaneously. Lilly is positioning the drug as the next pillar of its obesity portfolio alongside Zepbound and Foundayo, its recently launched weight loss pill.
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