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

• 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.

• Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or

• Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:

⁃ Obesity (BMI ≥30 kg/m2)

⁃ Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria

⁃ ALT \>1.5× upper limit of normal (ULN).

• For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.

• Stable body weight.