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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Change in Alanine Aminotransferase (ALT)
Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Time frame: Day 28/ET
Relative Percent Change in Alanine Aminotransferase (ALT)
Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Time frame: Baseline to Day 28/ET
Change in Aspartate Aminotransferase (AST)
Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.
Time frame: Day 28/ET
Levels of cCK18/M30
Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo
Time frame: Day 28/ET
Levels of Caspase 3/7 RLU
Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo
Time frame: Day 28/ET
Levels of flCK18/M65
Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo
Time frame: Day 28/ET
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Kansas City Research Institute
Kansas City, Missouri, United States
Mary Immaculate Hospital
Newport News, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States