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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 96 weeks
Awards & highlights

STAT NASH Trial 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.Check my eligibility
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.See study design
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.

STAT NASH Trial Eligibility Criteria

Inclusion Criteria

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

STAT NASH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in capture attention parameter (CAP) score (with Fibroscan®)
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
+5 more

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

STAT NASH 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
3,209 Previous Clinical Trials
3,767,080 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
1,079 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,436 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
2,694 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are making up this research trial?

"Currently, this investigation is not looking to recruit any more patients. It was first posted on December 1st 2022 and the details were last updated around October 21st 2022. For those wanting alternative trials, there are 234 ongoing studies for NASH sufferers and 70 clinical tests accepting participants who need a daily 40 mg dose of Atorvastatin."

Answered by AI

Has the Food and Drug Administration approved a daily dosage of Atorvastatin at forty milligrams?

"The safety of a daily dosage of 40mg Atorvastatin has been assessed as 2 on the 1-3 scale due to available evidence supporting its safe use, but not yet for efficacy."

Answered by AI

What are the qualifications for suitable candidates to join this medical trial?

"This medical trial is recruiting 70 individuals with a diagnosis of NASH, between the ages 18 and 70. Individuals must have also been diagnosed with NAFLD activity score (NAS) ≥ 4 within 90 days prior to randomization and not be taking statin therapy. For female participants of child-bearing age, effective contraception measures are required during the study period."

Answered by AI

Are recruitment efforts ongoing for this research initiative?

"Unfortunately, no new participants are being sought at this time. The trial was first posted on December 1st 2022 and most recently updated October 21st 2022. If you're searching for alternative medical studies, 234 trials recruiting patients with NASH are in progress as well as 70 Atorvastatin (40 mg daily) clinical trials currently active."

Answered by AI

Could you provide details regarding any other research initiatives involving a dosage of Atorvastatin (40 mg daily)?

"First studied in 2005, atorvastatin (40 mg daily) has been subject to 18706 completed trials. Presently, 70 clinical studies are being conducted with a major focus on Durham, North carolina."

Answered by AI

Is this investigation a pioneering venture?

"Ever since 2005, Atorvastatin (40 mg daily) has been extensively investigated. Merck Sharp & Dohme LLC launched the inaugural trial in that year which tested 80 participants. Following a successful Phase 4 approval of the drug, there are currently 70 ongoing studies for it across 28 nations and 162 cities."

Answered by AI

Is this exploration accommodating individuals more than 45 years old?

"In accordance with the study's inclusion criteria, participants must be between the ages of 18 and 70."

Answered by AI

What medical conditions is a daily dose of Atorvastatin (40 mg) typically prescribed for?

"Atorvastatin, which is normally taken in a dosage of 40mg per day, has been found to be particularly effective at managing lipidemias. This medication can also ameliorate postoperative thromboembolism and reduce anginal pain or transient ischemic attack symptoms."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Statins for the Treatment of NASH
Manal F. Abdelmalek 2023. "Statins for the Treatment of NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04679376.
All > Fatty Liver Disease > Lipitor
~22 spots leftby Dec 2024
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