Eli Lilly Initiates Phase 3 Clinical Trials of Tirzepatide and Retatrutide for MASLD

▎Armstrong

On September 10, 2025, Eli Lilly registered a Phase III clinical trial for Tirzepatide and Retatrutide in the treatment of MASLD on Clinicaltrials.gov.

This Phase III clinical trial plans to enroll 4,500 patients with MASLD and is expected to be preliminarily completed by 2030.

This Phase III clinical trial simultaneously explores the efficacy and safety of Tirzepatide and Retatrutide in treating MASLD.

The primary endpoint of this Phase III clinical trial is the MALO composite endpoint.

Summary

Eli Lilly has always been at the forefront of multi-target GLP-1 research and development. Tirzepatide is the world's first GLP-1/GIP dual-target agonist, and Retatrutide is the world's first GLP-1/GIP/GCG triple-target agonist. Retatrutide currently has several Phase III clinical trials ongoing, covering obesity and type 2 diabetes, with a new Phase III clinical trial for MASLD recently initiated. In addition, Retatrutide is also being explored for indications such as chronic kidney disease (CKD).