This clinical trial is for men and women who have been diagnosed with NonAlcoholic Steatohepatitis (NASH) and liver fibrosis (damaged/scarred liver tissue). Due to NASH, the liver is swollen and damaged because of a buildup of fat in the liver.
This study will seek to find out how safe and effective the investigational drug, Obeticholic acid (OCA), may be in delaying specific medical conditions or health related issues that can occur in individuals with NASH and evidence of liver fibrosis.
An investigational drug (also called a study drug) is one that has not been approved for sale by the FDA but is permitted to be used in this research study.
If eligible for this study, individuals will be randomly (like flipping a coin) to one of the following three study drug groups:
Subjects will be asked to come back to the clinic 8 times (for Month 0 [Day 1] Visit, Month 1 Visit, Month 3 Visit, and then every 3 months) for the first 18 months and then 2 times per year (every 6 months) for each additional year the subject is in the study. This study will last about six years.
Study participants will be compensated for their time.