Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment


I'm Interested

Trial ID: NCT02548351


The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Official 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

Stanford Investigator(s)

Aijaz Ahmed, MD
Aijaz Ahmed, MD

Professor of Medicine (Gastroenterology and Hepatology)


Inclusion Criteria:

   1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than
   6 months before Day 1 defined by presence of all 3 key histological features of NASH
   according to NASH CRN criteria.

   2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring
   of fibrosis, or

   Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the
   following risk factors:

      - Obesity (BMI ≥30 kg/m2)

      - Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria

      - ALT >1.5× upper limit of normal (ULN).

   3. For subjects with a historical biopsy, is either not taking or is on stable doses of
   TZDs/glitazones or vitamin E for 6 months before Day 1.

   4. Stable body weight.

Exclusion Criteria:

   1. Model for End-stage Liver Disease (MELD) score >12

   2. ALT ≥10× ULN

   3. HbA1c >9.5%

   4. Total bilirubin >1.5 mg/dL

   5. Evidence of other known forms of known chronic liver disease such as alcoholic liver
   disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
   iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
   suspected hepatocellular carcinoma (HCC)

   6. History of liver transplant, or current placement on a liver transplant list

   7. Current or history of significant alcohol consumption

   8. Prior or planned ileal resection, or prior or planned bariatric surgery

   9. Histological presence of cirrhosis

10. History of biliary diversion

11. Known positivity for human immunodeficiency virus infection.

12. Acute cholecystitis or acute biliary obstruction.

13. BMI >45 kg/m2


drug: Obeticholic Acid

drug: Placebo

drug: Obeticholic Acid

drug: Placebo


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pranali Suryavanshi