A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with nonalcoholic fatty liver disease to see if the medicine is effective and safe in the treatment of that disease.

Phase 1

Conditions: onalcoholic steatohepatitis
MedDRA version: 25.0Level: PTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-002560-16-DE

Lead Sponsor: Intercept Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2370

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 with a score of at least 1 for each
and a combined score of 4 or greater out of a possible 8 points 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, or 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Key Exclusion Criteria:
1. Model for End-stage Liver Disease (MELD) score >12
2. ALT =10x 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method