The REGENERATE Study

Condition: Nonalcoholic Steatohepatitis

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Evidence of NASH based on a liver biopsy obtained no more than 6 months before Day 1 of the study
  • Evidence of Stage 2 or 3 fibrosis or evidence of Stage 1a or 1b fibrosis if accompanied by specific risk factor(s). Note: the study is no longer accepting patients with Stage 1 fibrosis, only Stage 2 or 3.

Key Exclusion Criteria

  • Current or history of significant alcohol consumption for a period of more than 3 consecutive months within one year before screening 
  • Prior or planned (during the study period) ileal resection, or prior or planned bariatric surgery 
  • Other forms of known chronic liver disease

Full Study Name

A Phase III, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis (IRB no. 41188)

Summary

The purpose of this study is to evaluate an investigational drug called obeticholic acid (also known as OCA) and its effect on nonalcoholic steatohepatitis (NASH). OCA is a modified version of a natural compound made in the liver called bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function. Researchers aim to determine the safety and effectiveness of OCA in delaying or preventing specific medical conditions or health-related issues that can occur in patients with NASH and who have evidence of liver fibrosis (damaged and scarred liver tissue). Patients will be randomly assigned to receive OCA or a placebo (inactive substance).

Phase

Phase III

Principal Investigator

Mazen Noureddin, MD

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