Clinical Research Details

Clinical Research

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis

Study Description

The purpose of this study is to find out if OCA may be safe and effective in delaying specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis.

Subjects will be randomized to 1 of 2 study drug doses or placebo.

Inclusion/Exclusion Criteria

Inclusion Criteria:

  1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis,:


Exclusion Criteria:

  1. Evidence of other known forms of known chronic liver disease
  2. History of liver transplant, or current placement on a liver transplant list
  3. Current or history of significant alcohol consumption
  4. Prior or planned ileal resection, or prior or planned bariatric surgery
  5. Histological presence of cirrhosis
  6. History of biliary diversion
  7. Known positivity for human immunodeficiency virus infection.