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Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT02548351•Intercept Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (346)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Key Dates

Start Date

September 22, 2015

Primary Completion Date

September 15, 2023

Completion Date

September 15, 2023

Last Updated

October 1, 2024

Enrollment

2,477

ACTUAL participants

Conditions

Non Alcoholic Steatohepatitis (NASH)

Interventions

Obeticholic Acid

DRUG

Placebo

DRUG

A Phase 2b Study of Icosabutate in Fatty Liver Disease

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Non Alcoholic Steatohepatitis (NASH)

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UNKNOWNPHASE2

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NCT04880187

Non Alcoholic Steatohepatitis (NASH)

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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