Investigational Drug for the treatment of Nonalcoholic Steatohepatitis (NASH)
Paul J. Pockros, M.D.
This study is evaluating how safe and effective the investigational drug Obeticholic Acid (OCA) may be in delaying or preventing medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis. Participation will last up to 6 years and requires up to 8 office visits within the first 2 years and then once a year thereafter.
Be 18 years or over
Have been diagnosed with NASH with fibrosis by liver biopsy
Have a stable body weight for at least 3 months
Have had bariatric surgery
Have type 1 diabetes, cirrhosis, known heart failure, or uncontrolled high blood pressure
Have unstable diabetes Type 2
Be pregnant or planning a pregnancy
Be unwilling to use birth control if able to get pregnant
Patients will be randomized to receive 10mg of OCA, 25mg of OCA, or a matching placebo once a day for the duration of the study, in conjunction with local standard of care.