Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

Phase 2 Completed 243 enrolled Mochida Pharmaceutical Company, Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

Timeline

Start: 2010-06
Primary completion: 2012-10
Completion: 2012-10

Publications

Sanyal AJ, Abdelmalek MF, Suzuki A, Cummings OW, Chojkier M; EPE-A Study Group. No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. Gastroenterology. 2014 Aug;147(2):377-84.e1. doi: 10.1053/j.gastro.2014.04.046. Epub 2014 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	icosapent ethyl	Small molecule	1800 mg	—
Subject	icosapent ethyl	Small molecule	2700 mg	—

Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

Summary

Timeline

Publications

Drugs

Indications