A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

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Detailed Description

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This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

Conditions

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Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IDN-6556

IDN-6556 capsules, 25 mg BID

Group Type EXPERIMENTAL

IDN-6556

Intervention Type DRUG

25 mg BID for 28 days

Placebo

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo BID for 28 Days

Interventions

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IDN-6556

25 mg BID for 28 days

Intervention Type DRUG

Placebo

Placebo BID for 28 Days

Intervention Type OTHER

Other Intervention Names

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emricasan PF-03491390

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
* Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
* Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
* alpha-fetoprotein (AFP) ≤ 100 ng/mL
* Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10\^9/L, and a white blood cell count ≥ 3.0 x 10\^9/L
* If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study

Exclusion Criteria

* Known infection with HIV, HCV, or HBV
* Decompensated or severe liver disease as evidenced by one or more of the following:

1. Confirmed cirrhosis or suspicion of cirrhosis
2. Esophageal varices
3. Ascites
4. Suspicion of portal hypertension
5. Hospitalization for liver disease within 60 days of screening
6. Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN
* Inflammatory bowel disease
* Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
* Hepatocellular carcinoma (HCC) at entry into the study
* History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
* Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
* History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No