INDIANAPOLIS (dpa-AFX) - Thursday, Eli Lilly and Company (LLY) announced positive topline results from pivotal Phase 3 trials - TRIUMPH-2 and TRIUMPH-3, evaluating the efficacy and safety of retatrutide.
In TRIUMPH-2, participants with type 2 diabetes and obesity or overweight received retatrutide 4 mg, 9 mg, 12 mg, or placebo. Meanwhile, participants with severe obesity and established cardiovascular disease in TRIUMPH-3 received retatrutide 9 mg, 12 mg, or placebo.
In both studies, retatrutide met the primary endpoint. Participants in TRIUMPH-2 lost up to an average of 49.6 lbs and showed improvement in glycemic control at 80 weeks, whereas participants in TRIUMPH-3 lost up to an average of 55.8 lbs alongside A1C reductions of up to an average of 1.6 percent during the same period.
Additionally, retatrutide demonstrated meaningful reduction in certain cardiovascular risk factors, such as triglycerides, non-HDL cholesterol, waist circumference, and high-sensitivity C-reactive protein in TRIUMPH-3.
The company expects to use these positive findings to support global submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea.
Lilly plans to submit a Biologics License Application for retatrutide to FDA in the first quarter of 2027.
In the pre-market hours, LLY is trading at $1,157.51, down 0.48 percent on the New York Stock Exchange.
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