Phase III trials confirm benefits of Lilly’s triple agonist retatrutide
Eli Lilly has announced positive topline results from TRIUMPH-2 and TRIUMPH-3, two pivotal Phase III trials evaluating retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist.
In both studies, retatrutide met the primary endpoint, delivering substantial weight loss in adults with obesity and some of its most serious complications: type 2 diabetes and established cardiovascular disease.
“Across five positive Phase III studies, retatrutide has shown powerful efficacy, and we believe it could be an important future tool in the management of cardiometabolic health,” said Dr Kenneth Custer, Executive Vice President and President, Lilly Cardiometabolic Health. “With the positive results from TRIUMPH-2 and TRIUMPH-3, we now have the clinical data package to support global submissions for retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnoea. We look forward to working with regulators as they evaluate this first-of-its-kind medicine.”
In TRIUMPH-2, retatrutide (4mg, 9mg, and 12mg) delivered substantial weight loss and improved glycaemic control at 80 weeks in adults with type 2 diabetes and obesity or overweight. Participants lost an average of 29.8 lbs (12.7%), 45.4 lbs (19.1%), and 49.6 lbs (20.8%), respectively, alongside A1C reductions of up to an average of 1.6%.
In TRIUMPH-3, retatrutide (9mg and 12mg) delivered substantial weight loss in adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes. Participants lost up to an average of 55.8 lbs (22.6%) at 80 weeks.
In the study, major adverse cardiovascular events (MACE) occurred less frequently than anticipated in both retatrutide and placebo arms.
In TRIUMPH-3, retatrutide meaningfully reduced certain cardiovascular risk factors, with the highest dose delivering average reductions of 37.0% in triglycerides, 16.5% in non-HDL cholesterol, 9.3mmHg in systolic blood pressure, 7.5 in (19cm) in waist circumference, and 51.2% in high-sensitivity C-reactive protein (hsCRP).