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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Jun 2016

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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