A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.

Timeline

Start

2017-12-27

Primary completion

2019-04-03

Completion

2020-06-30

Outcome

Missed primary endpoint

paper There was no significant difference between the groups in the primary endpoint (-5.3% vs -4.2%; treatment difference -1.0%, P = 0.85). PMID 34528723 ↗

Publications

• Tanigawa R, Loomba R, Eguchi Y, Takahashi H, Suganami H, Tanahashi M, Belous A, Nakajima A. Post Hoc Analysis of a Phase 2 Randomized Trial of Pemafibrate in Metabolic Dysfunction-associated Steatotic Liver Disease: Associations With Platelet Count, Liver Stiffness, and Spleen Volume. J Clin Exp Hepatol. 2026 Jul-Aug;16(4):103525. doi: 10.1016/j.jceh.2026.103525. Epub 2026 Mar 3.
• Nakajima A, Eguchi Y, Yoneda M, Imajo K, Tamaki N, Suganami H, Nojima T, Tanigawa R, Iizuka M, Iida Y, Loomba R. Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMalpha), versus placebo in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2021 Nov;54(10):1263-1277. doi: 10.1111/apt.16596. Epub 2021 Sep 16.
• Fruchart JC, Hermans MP, Fruchart-Najib J, Kodama T. Selective Peroxisome Proliferator-Activated Receptor Alpha Modulators (SPPARMalpha) in the Metabolic Syndrome: Is Pemafibrate Light at the End of the Tunnel? Curr Atheroscler Rep. 2021 Jan 3;23(1):3. doi: 10.1007/s11883-020-00897-x.

Drugs

Indications