Eli Lilly and Co. (NYSE:LLY) on Thursday reported topline results from two pivotal Phase 3 trials for its investigational triple-hormone agonist, retatrutide.
The studies demonstrated significant weight reduction in adult patients managing obesity alongside severe complications, including type 2 diabetes and established cardiovascular disease.
In May, Eli Lilly said the TRIUMPH-1 trial of retatrutide showed patients losing as much as 28.3% of body weight after 80 weeks of treatment.
Significant Weight Loss Across Trials
The pharmaceutical developer, known for treatments like Zepbound and Foundayo, is testing retatrutide as a once-weekly medication that uniquely targets three distinct hormone receptors: GIP, GLP-1, and glucagon.
Both the TRIUMPH-2 and TRIUMPH-3 trials met their primary endpoints.
In the TRIUMPH-2 study, which involved adults with type 2 diabetes and obesity or excess weight, the medication improved glycemic control while driving major weight loss.
Over 80 weeks, participants on the 4 mg, 9 mg, and 12 mg doses dropped an average of 29.8 pounds, 45.4 pounds, and 49.6 pounds, respectively. The treatment also reduced A1C levels by up to an average of 1.6%.
Cardiovascular Benefits And Regulatory Outlook
The TRIUMPH-3 trial focused on individuals with severe obesity and pre-existing cardiovascular conditions.
After 80 weeks, subjects on the 9 mg and 12 mg doses recorded average weight drops of up to 55.8 pounds, or 22.6%.
Furthermore, retatrutide effectively lowered key cardiovascular risk factors.
The highest dose slashed triglycerides by 37% and systolic blood pressure by 9.3 mmHg, while also significantly reducing waist circumference and high-sensitivity C-reactive protein.
Regarding cardiovascular safety, major adverse events occurred less frequently than projected in both the medication and placebo groups.
Eli Lilly is actively preparing its required manufacturing data for a Biologics License Application. U.S. regulatory submission for retatrutide is targeted for the first quarter of 2027.
LLY Price Action: Eli Lilly shares were down 1.03% at $1151.00 during premarket trading on Thursday, according to Benzinga Pro data.
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