A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

Summary

The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

Timeline

Start

2019-11-19

Primary completion

2023-12-11

Completion

2024-01-10

Outcome

Met primary endpoint

registry analysis (superiority test); 5 mg Tirzepatide vs Placebo; p <0.001; Odds Ratio (OR) 7.45 (95% CI 2.27 to 24.44); Regression, Logistic NCT04166773 ↗

registry analysis (superiority test); 10 mg Tirzepatide vs Placebo; p <0.001; Odds Ratio (OR) 11.86 (95% CI 3.59 to 39.11); Regression, Logistic NCT04166773 ↗

registry analysis (superiority test); 15 mg Tirzepatide vs Placebo; p <0.001; Odds Ratio (OR) 19.63 (95% CI 5.73 to 67.25); Regression, Logistic NCT04166773 ↗

Publications

• Loomba R, Hartman ML, Lawitz EJ, Vuppalanchi R, Boursier J, Bugianesi E, Yoneda M, Behling C, Cummings OW, Tang Y, Brouwers B, Robins DA, Nikooie A, Bunck MC, Haupt A, Sanyal AJ; SYNERGY-NASH Investigators. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. N Engl J Med. 2024 Jul 25;391(4):299-310. doi: 10.1056/NEJMoa2401943. Epub 2024 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tirzepatide	Peptide	5 mg	Subcutaneous
Subject	Tirzepatide	Peptide	10 mg	Subcutaneous
Subject	Tirzepatide	Peptide	15 mg	Subcutaneous

Indications