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Intercept - REGENERATE Study of Obeticholic Acid 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)

What is the Condition Being Studied?

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

Age Group
Adults

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.

Study Details

Full Title
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
Principal Investigator
Protocol Number
IRB:PRO00063168
NCT:NCT02548351
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698