Statins for the Treatment of NASH

NCT04679376 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-007824
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....

  Baseline, 96 weeks

• Change in fibrosis stage as measured by change in stage

  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.

  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

Study Arms (2)

Group 1: Atorvastatin Treatment

EXPERIMENTAL

Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks

Drug: Atorvastatin

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

Drug: Placebo

Interventions

Atorvastatin DRUG

40 mg daily administered orally in tablet or capsule form

Also known as: Lipitor

Group 1: Atorvastatin Treatment

Placebo DRUG

Administered daily orally in tablet or capsule form, contains no active medicine

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite NASH on a liver biopsy obtained ≤ 90 days prior to randomization with a NAFLD activity score (NAS) of ≥ 4 with at least 1 in each component of the NAS according to NASH CRN grading52
• Fibrosis stage ≥ 2 as assessed by liver biopsy
• Not currently on statin therapy
• Provision of written informed consent
• Agree to use of effective contraceptive measures if female of child bearing potential.

You may not qualify if:

• The presence of any of the following will exclude a subject from study enrollment: Any chronic liver disease other than NASH (i.e., drug-induced, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, A1AT deficiency, Wilsons disease)
• Cirrhosis, as assessed clinically or histologically
• Presence of vascular liver disease
• BMI ≤ 25 kg/m2
• Excessive alcohol use (\> 20 g/day) within the past 2 years
• AST or ALT \> 250 U/L.
• Type 1 diabetes mellitus
• Bariatric surgery in the past 5 years.
• Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
• Inadequate venous access
• HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or HCV RNA positive.
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Any history of complications of cirrhosis (i.e. ascites, hepatic encephalopathy, or portal hypertensive bleeding), even if absent or optimized with medical management at time of screening
• Concurrent conditions: a) Inflammatory bowel disease, b) Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of screening, c) Ongoing infectious, immune mediated disease within previously 1 years, d) Any malignant disease (other than basal cell carcinoma of the skin) within previous 5 years, e) Prior solid organ transplant, f) Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Manal Abdelmalek, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)