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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Atorvastatin Treatment | Experimental | Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks |
|
| Group 2: Placebo | Placebo Comparator | Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive a placebo for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 40 mg daily administered orally in tablet or capsule form |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH)..... | Histological change from NASH to No NASH | Baseline, 96 weeks |
| Change in fibrosis stage as measured by change in stage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manal Abdelmalek, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States | ||
| Duke University Medical Center |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2025 | Jan 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Administered daily orally in tablet or capsule form, contains no active medicine |
|
Ordinal variable
| 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. | Baseline, 96 weeks |
| Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations | Baseline, 96 weeks |
| Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan®) | Baseline, 96 weeks |
| Change in capture attention parameter (CAP) score (with Fibroscan®) | Baseline, 96 weeks |
| Serum creatine phosphokinase (CPK) as measured by serum concentration | Baseline, 96 weeks |
| Change in serum lipids as measured by serum concentration | Baseline, 96 weeks |
| Durham |
| North Carolina |
| 27710 |
| United States |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |