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HMG-CoA Reductase Inhibitor

Statins for Non-alcoholic Steatohepatitis (NASH) (STAT NASH Trial)

Phase 2
Recruiting
Led By Ayako Suzuki
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 ≤ 70 years
Fibrosis stage ≥ 2 as assessed by liver biopsy
Must not have
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)
Chronic pancreatitis or pancreatic insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 96 weeks

Summary

This trial will test whether or not a daily dose of atorvastatin (a type of statin) is effective in treating NASH and hepatic fibrosis, and whether it is safe. The results of this study will help design a larger study on the matter.

Who is the study for?
Adults aged 18-70 with a certain stage of liver scarring (fibrosis) and confirmed NASH, not on statins or other specific treatments for NASH. Participants must have had a recent liver biopsy showing definite NASH. They should not be heavy drinkers, have other serious health conditions, or be pregnant/breastfeeding. Women who can bear children must agree to use effective contraception.
What is being tested?
The trial is testing the safety and effectiveness of atorvastatin (Lipitor®), a cholesterol-lowering drug, in improving the condition of patients with Non-alcoholic Steatohepatitis (NASH). Some participants will receive atorvastatin while others will get a placebo to compare outcomes.
What are the potential side effects?
Atorvastatin may cause muscle pain or weakness, digestive issues like constipation or diarrhea, headache, increased blood sugar levels which could lead to diabetes risk over time, and possible liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My liver fibrosis stage is 2 or higher.
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I am not taking statin medication.
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My recent liver biopsy confirms I have NASH with a specific severity score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a liver condition, but it's not NASH or related to drugs, viruses, autoimmune issues, or genetic disorders.
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I have long-term pancreatitis or my pancreas does not work properly.
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I have Type 1 diabetes.
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I had weight loss surgery within the last 5 years.
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I am on a special liquid diet or receiving nutrition through my veins.
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I am a woman able to have children and agree to use birth control during and 1 month after the trial.
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I have a liver disease involving my blood vessels.
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I have had complications from liver cirrhosis, even if they are now under control.
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I have been diagnosed with cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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).
Secondary study objectives
Change in each component of NASH histologic features as measured by presence or ab presence or absence of features or their severity.
Change in fibrosis stage as measured by change in stage
NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069
3%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Atorvastatin TreatmentExperimental Treatment1 Intervention
Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks
Group II: Group 2: PlaceboPlacebo Group1 Intervention
Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive a placebo for 96 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,105 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
1,079 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,721 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
2,084 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Ayako SuzukiPrincipal InvestigatorDuke University
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
20 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04679376 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Group 2: Placebo, Group 1: Atorvastatin Treatment
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04679376 — Phase 2
Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04679376 — Phase 2
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