The purpose of this research study is to determine whether the study drug, atorvastatin (Lipitor®), is safe and effective in improving the features of NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
40 mg daily administered orally in tablet or capsule form
Administered daily orally in tablet or capsule form, contains no active medicine
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
Change in NASH as measured by improvement in NAS score Improvement in NAS score (≥ 2 points) with no worsening in fibrosis stage (≥1 point) OR improvement in fibrosis with no worsening of NASH (change in the NAS score of ≤ 0 points).
One overall score of NASH improvement will be derived from improvement in NAS score OR no worsening in fibrosis.
Time frame: Baseline, 96 weeks
NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....
Histological change from NASH to No NASH
Time frame: Baseline, 96 weeks
Change in fibrosis stage as measured by change in stage
Ordinal variable
Time frame: Baseline, 96 weeks
Change in each component of NASH histologic features as measured by presence or ab presence or absence of features or their severity.
Existing features may improve in severity or disappear as an indication of improvement of NASH.
Time frame: Baseline, 96 weeks
Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations
Time frame: Baseline, 96 weeks
Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan®)
Time frame: Baseline, 96 weeks
Change in capture attention parameter (CAP) score (with Fibroscan®)
Time frame: Baseline, 96 weeks
Serum creatine phosphokinase (CPK) as measured by serum concentration
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Time frame: Baseline, 96 weeks
Change in serum lipids as measured by serum concentration
Time frame: Baseline, 96 weeks