People with Type 2 diabetes who took the highest dose of Eli Lilly’s experimental drug retatrutide lost an average of nearly 50 pounds, the company said.
In a late-stage study, participants taking a 12-milligram dose for 80 weeks lost an average of 49.6 pounds, or nearly 21% of their body weight, Lilly said. Participants with a body mass index of 35 or higher lost an average of nearly 61 pounds on that dose.
What Did the Retatrutide Study Find?
Participants taking the two lower doses lost an average of 12.7% and 19.1% of their body weight, respectively. The medication also lowered A1C, a measure of blood sugar, Lilly said. Common side effects included diarrhea, nausea, constipation, decreased appetite and vomiting.
The findings were published Sept. 29 in The Lancet. The results follow earlier studies of retatrutide, which some experts say produced weight loss comparable to bariatric surgery.
Lilly already sells the weight-loss drug Zepbound and the Type 2 diabetes medication Mounjaro. The company expects to seek Food and Drug Administration approval for retatrutide before the end of March 2027.
On Sept. 30, Lilly also reported results for another experimental weight-loss drug, EloraTZP. In a mid-stage trial of 367 adults with Type 2 diabetes and obesity or overweight, people who took a high-dose combination of EloraTZP and Zepbound lost up to 54 pounds, or more than 23% of their body weight, Lilly said.
How Is Retatrutide Different?
Existing weight-loss drugs such as Wegovy, commonly called GLP-1s, mimic glucagon-like peptide-1, a hormone that helps regulate metabolism. Retatrutide acts on three gut hormone receptors: GIP, GLP-1 and glucagon.
Lilly said it plans to seek FDA approval for retatrutide as a biologic medication. It also plans to present details about the drug’s potential as a treatment for obstructive sleep apnea at a future medical meeting and in a peer-reviewed journal.
Why Is Lilly Seeking Biologic Status?
Drug-pricing experts say classifying retatrutide as a biologic rather than a small-molecule drug could give it a longer period without direct competition. Biologic drugs can have 12 years of exclusivity before a biosimilar competitor can be approved, compared with a five-year window for many small-molecule drugs.
“Biologics get a lot of additional protections that small molecule drugs don’t get. They get longer exclusivity guaranteed by the FDA,” said Dr. Benjamin Rome, a Harvard Medical School professor and drug-pricing expert.
One potential advantage for Lilly is that prices have not fallen as much with biosimilars as they have with generic competition, Rome said.
Lilly has also sued compounding pharmacies, medical spas and others it says illegally marketed counterfeit versions of retatrutide. The company filed six such lawsuits in August.
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