This clinical trial is for men and women who have been diagnosed with compensated cirrhosis as a result of non-alcoholic steatohepatitis (NASH). NASH is the result of too much fat within the liver, resulting in injury and death to individual liver cells; the presence of injury like this is followed by progressive formation (laying down) of liver fibrosis (scar tissue); the result of this is increased liver stiffness. As more fibrosis is formed in the liver, the outcome is cirrhosis. Compensated cirrhosis means the liver has become very scarred but can still perform many important bodily functions.
This study is being conducted to find out how safe and effective the investigational drug Obeticholic acid (OCA) may be in improving compensated cirrhosis caused by NASH.
OCA (the brand name is Ocaliva) has been approved in several regions in North America (including the United States and Canada) and Europe for the treatment of another form of chronic liver disease called Primary Biliary Cholangitis (PBC). However, OCA has not been not been approved by the United States of America Food and Drug Administration (FDA) to treat cirrhosis as the result of NASH but it is permitted to be used in this research study.
This study has two parts:
Part 1 is called the Double‐Blind study drug administration period because neither the participant nor the study doctor will know what study group the participant was assigned to. Individuals will be randomly assigned (like flipping a coin) to one of the following three study drug groups:
Part 2 is called the Open‐Label Extension period because all participants will receive the study drug (OCA) during this part and no one will receive placebo.
In Part 1, participants will be asked to come back to the clinic 9 times (for the Day 1, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, and Month 12 Visits). In Part 2, participants will be asked to come back to the clinic 8 times (for the Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, and Month 12 visits).
Participation in both Part 1 and Part 2 may last up to approximately 2 years. Participants will be compensated for their time.