Eli Lilly and Company, the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced positive topline results from two pivotal phase 3 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.
In one of the studies, all three studied doses of retatrutide (4 mg, 9 mg, and 12 mg) delivered substantial weight loss and improved glycaemic control at 80 weeks in adults with type 2 diabetes and obesity or overweight. Participants taking retatrutide 4 mg, 9 mg, and 12 mg 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 the other study, both studied doses of retatrutide (9 mg and 12 mg) 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.
Detailed results from both studies will be presented at future medical meetings and published in peer-reviewed journals.
Eli Lilly and Company is completing the comprehensive Chemistry, Manufacturing, and Controls (CMC) data package required for a Biologics License Application (BLA) and plans to subsequently submit retatrutide in Q1 2027 for US approval.
