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
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
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Inclusion Criteria:
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:
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.
Exclusion Criteria:
Wyoming, Michigan 49519, United States
Buffalo, New York 14203, United States
Chapel Hill, North Carolina 27599-7584, United States
Huntersville, North Carolina 28078, United States
Hershey, Pennsylvania 17033, United States
Greenville, South Carolina 29605, United States
Houston, Texas 77030, United States
Richmond, Virginia 23298, United States
Heidelberg, Baden-Wurttemberg 69120, Germany
Leipzig, Saxony 04103, Germany
Katowice, 40-752, Poland
Manchester, M13 9WL, United Kingdom