Trial Profile

Phase II trial of obeticholic acid in patients with non-alcoholic steatohepatitis in Japan.

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 16 Feb 2018

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At a glance

Drugs Obeticholic acid (Primary)
Indications Non-alcoholic steatohepatitis
Focus Therapeutic Use
Sponsors Sumitomo Dainippon Pharma

Most Recent Events

28 Oct 2015 Primary endpoint "Histologic improvement defined as at least a two point improvement in NAFLD activity score (NAS) with no worsening of fibrosis" has been met for the 40 mg dose of obeticholic acid, according to an Intercept Pharmaceuticals media release.
28 Oct 2015 Results published in an Intercept media release.
28 Mar 2014 New trial record

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