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.
- Trial ID:
- Paul J. Pockros, M.D.
- 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.