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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with NASH (Intercept 747-303)

Clinical Trial Details

This clinical trial is for men and women who have been diagnosed with NonAlcoholic Steatohepatitis (NASH) and liver fibrosis (damaged/scarred liver tissue). Due to NASH, the liver is swollen and damaged because of a buildup of fat in the liver.

This study will seek to find out how safe and effective the investigational drug, Obeticholic acid (OCA), may be in delaying specific medical conditions or health related issues that can occur in individuals with NASH and evidence of liver fibrosis.

An investigational drug (also called a study drug) is one that has not been approved for sale by the FDA but is permitted to be used in this research study.

If eligible for this study, individuals will be randomly (like flipping a coin) to one of the following three study drug groups:

  • Group A:  Placebo, a “sugar (dummy pill)”  that contains no real study drug
  • Group B:  OCA 10 mg
  • Group C:  OCA 25 mg

Subjects will be asked to come back to the clinic 8 times (for Month 0 [Day 1] Visit, Month 1 Visit, Month 3 Visit, and then every 3 months) for the first 18 months and then 2 times per year (every 6 months) for each additional year the subject is in the study. This study will last about six years.

Study participants will be compensated for their time.

Key Eligibility: 
  • Men and women who are 18 years of age and older
  • Must be diagnosed with NASH and liver scarring
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1511016774

Sponsor:

Intercept 747-303

Status

Open to Enrollment

Age Group

Adult

Sponsor