A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
Condition: Nonalcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: IDN-6556; Placebo
Intervention description: 25 mg BID for 28 days; Placebo BID for 28 Days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NAFLD; NASH

Summary:

      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
    

Eligibility criteria:

        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