Intercept - REGENERATE Trial for NASH - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn whether a medicine called obeticholic acid reduces fat and fibrosis (scarring of connective tissue) in the liver in people who have NASH (non-alcoholic steatohepatitis)
Nonalcoholic Fatty Liver Disease (NASH)
Who Can Participate in the Study?
Adults over 18 years of age who:
- Have nonalcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis
- Have not had major illness related to your heart and blood vessels within the past 12 months
- Are able to have a liver biopsy
What is Involved?
If you join the study, you will:
- Have study visits every 3 months for 18 months, then every 6 months
- Give blood samples, have an ultrasound, MRI (Magnetic Resonance Imaging), and other scans
- Have a liver biopsy
- Be randomized (like drawing numbers from a hat) to one of three groups:
-- Group A: Placebo (an inactive pill)
-- Group B: obeticholic acid 5mg by mouth daily
-- Group C: obeticholic acid 25mg by mouth daily
Neither you nor your doctor will know what you're taking
You'll be in the study up to 7 years depending on when you are enrolled.