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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non Alcoholic Steatohepatitis (NASH)

In brief

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.

Key facts

Study ID

NCT02548351

Run by

Intercept Pharmaceuticals

People needed

2477

Starts

2015-09-22

Expected to finish

2023-09-15

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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).
• 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.
• Stable body weight.

You may not qualify if…

• Model for End-stage Liver Disease (MELD) score >12
• ALT ≥10× ULN
• HbA1c >9.5%
• Total bilirubin >1.5 mg/dL
• 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)
• History of liver transplant, or current placement on a liver transplant list
• Current or history of significant alcohol consumption
• Prior or planned ileal resection, or prior or planned bariatric surgery
• Histological presence of cirrhosis
• History of biliary diversion
• Known positivity for human immunodeficiency virus infection.
• Acute cholecystitis or acute biliary obstruction.
• BMI >45 kg/m2

Where it is running

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• Institute for Liver Health DBA Arizona Liver Health — Chandler, Arizona, United States
• Arizona Liver Health - Glendale — Glendale, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Arizona Liver Clinic - Tucson — Tucson, Arizona, United States
• Liver Wellness Center — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• GW Research Inc. — Chula Vista, California, United States
• Precision Research Institute — Chula Vista, California, United States
• Southern California Research Center — Coronado, California, United States
• Citrus Valley Gastroenterology — Covina, California, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• UCSF Fresno, Clinical Research Center — Fresno, California, United States
• Fresno Clinical Research Center — Fresno, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of California, San Diego — La Jolla, California, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• National Research Institute, Wilshire — Los Angeles, California, United States
• Gastrointestinal Biosciences — Los Angeles, California, United States
• Veteran Affairs Great Los Angeles Healthcare System — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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