Who is eligible for clinical trial NCT04679376?

Participants must meet protocol criteria for NASH - Nonalcoholic Steatohepatitis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04679376 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-16

Statins for the Treatment of NASH (NCT04679376)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (22 items).

Location: Mayo Clinic Minnesota — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Mayo Clinic Minnesota — Rochester, Minnesota
Duke University Medical Center — Durham, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗