A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Summary

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Timeline

Start

2021-08-04

Primary completion

2022-10-19

Completion

2022-10-19

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Efinopegdutide: 72.7 (66.8 to 78.7) Percent Reduction NCT04944992 ↗

registry analysis (superiority test); Efinopegdutide vs Semaglutide; p <0.0001; Difference in least squared means 30.4 (90% CI 22.1 to 38.7); Mixed Models Analysis NCT04944992 ↗

Publications

• Results Romero-Gomez M, Lawitz E, Shankar RR, Chaudhri E, Liu J, Lam RLH, Kaufman KD, Engel SS; MK-6024 P001 Study Group. A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. J Hepatol. 2023 Oct;79(4):888-897. doi: 10.1016/j.jhep.2023.05.013. Epub 2023 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efinopegdutide	Protein / enzyme biologic	10 mg	Subcutaneous
Comparator	Semaglutide	Peptide	1 mg	Subcutaneous

Indications