Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD

Summary

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)

Timeline

Start

2016-12-20

Primary completion

2019-01-02

Completion

2019-03-04

Outcome

Missed primary endpoint

paper Primary end points of changes in alanine aminotransferase and liver stiffness did not improve at week 16. PMID 32779505 ↗

paper While epeleuton did not meet its primary end points on alanine aminotransferase or liver stiffness PMID 32779505 ↗

Publications

• Climax J, Newsome PN, Hamza M, Weissbach M, Coughlan D, Sattar N, McGuire DK, Bhatt DL. Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers. J Am Heart Assoc. 2020 Aug 18;9(16):e016334. doi: 10.1161/JAHA.119.016334. Epub 2020 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epeleuton	Unknown	1000 mg	Oral
Subject	Epeleuton	Unknown	2000 mg	Oral

Indications