Eli Lilly said its investigational triple agonist retatrutide met the primary endpoint in two additional Phase 3 obesity trials, delivering substantial weight loss and improved glycemic control in adults with obesity and related complications. The company plans to submit a Biologics License Application to the FDA in the first quarter of 2027.
In TRIUMPH-2, adults with obesity or overweight and type 2 diabetes lost as much as an average of 49.6 pounds, or 20.8%, at 80 weeks on the highest dose studied, while also seeing A1C reductions of up to an average of 1.6%. Lilly said the trial population had increased difficulty losing weight, making the results especially notable.
In TRIUMPH-3, adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes, lost as much as an average of 55.8 pounds, or 22.6%, at 80 weeks. The company also said retatrutide reduced several cardiovascular risk factors, including triglycerides, non-HDL cholesterol, systolic blood pressure, waist circumference and high-sensitivity C-reactive protein.
Lilly said retatrutide is a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist. Company executives said the new data add to five positive Phase 3 studies and support broader global submissions for obesity, knee osteoarthritis pain and obstructive sleep apnea.
The most common adverse events in both studies were gastrointestinal, including diarrhea, nausea, constipation, decreased appetite and vomiting. Lilly said the events were generally mild to moderate and most resolved during treatment. Detailed results will be presented at future medical meetings and published in peer-reviewed journals.
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