Conditions: Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis (NASH)
Keywords: Farnesoid X Receptor FXR Nonalcoholic fatty liver disease Nonalcoholic steatohepatitis NAFLD NASH obeticholic acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 283
Healthy volunteers: no

Brief summary:
Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).

Detailed description:
To evaluate whether treatment with obeticholic acid, 25 mg daily for 72 weeks compared to treatment with placebo, improves the severity of nonalcoholic fatty liver disease (NAFLD) as determined from hepatic histology.

Arms:
arm 1: obeticholic acid arm 2: Placebo

Interventions: intervention 1: obeticholic acid intervention 2: placebo
Intervention descriptions: intervention 1: 25 mg daily for 72 weeks intervention 2: placebo capsule, 25 mg daily for 72 weeks

Protocol document: