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# Lilly’s Retatrutide Hits Endpoint in 2 Trials
- URL: https://www.fdaweb.com/lillys-retatrutide-hits-endpoint-in-2-trials/
- Published: 2026-07-23T12:00:00.000Z
- Updated: 2026-09-14T13:43:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161504

Lilly says its investigational first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist retatrutide met its primary endpoint in the Class 3 TRIUMPH-2 and TRIUMPH-3 studies, delivering substantial weight loss in adults with obesity complicated by type 2 diabetes and established cardiovascular disease. The company [says](https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional?ref=fdaweb.com) it plans to submit a BLA to FDA for retatrutide in the first quarter of 2027.

Lilly will present detailed results of the two trials at future medical meetings and will publish them in peer-reviewed journals, the statement says. The company says it is completing the comprehensive Chemistry, Manufacturing, and Controls data package that is needed for a BLA submission.

Retatrutide is described as an investigational, once-weekly, triple hormone receptor agonist. Lilly says retatrutide is a single molecule that activates the body’s receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. The company says it is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, including type 2 diabetes, knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease.