NASH - Nonalcoholic SteatohepatitisPhase 2STAT NASHNCT04679376
Statins for the Treatment of NASH
A Phase 2 study testing Atorvastatin in people with NASH - Nonalcoholic Steatohepatitis, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Concurrent medications including: a) Anti-NASH therapy(s) initiated after the liver biopsy diagnosing NASH. Anti-NASH therapies include S-adenosyl methionine (SAMe), milk thistle, and vitamin E at dose of ≥ 400 IU/day; b) Antidiabetic mediation which may impact NASH histology started in the past 12 months including thiazolidinediones (glitazones), dipeptidyl peptidase 4 inhibitors (gliptins) or glucagon-like peptide 1 analogs; c) Immune modulatory agents including systemic steroids, methotrexate, anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab).
- Self-reported or known marijuana or illicit drug use 30 days before the screening
- The following laboratory abnormalities within 90 days of screening: a) HbA1C > 9.0%, b) Neutrophil count < 1.0 x 109/L, c) Platelets < 100 109/L, d) Hemoglobin < 10 g/dl, e) Albumin < 3.5 g, f) Prolonged international normalized ratio (INR), g) Any elevation of bilirubin above normal (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction), h) Serum creatinine > 1.5 mg/dl, i) Creatinine clearance ≤ 50 ml/minute calculated by Crockroft-Gault or creatinine > 1.5x upper limit of normal
- Pregnancy or breastfeeding.
- Women, of childbearing age, who are not willing to practice effective contraception (i.e., barrier, oral contraceptives, or past medical history of hysterectomy) for the 48-week duration of the trial and for 1 month after the first administration of the drug.
- Participation in an investigational drug study within past 3 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Statins in Adult Patients With Non-Alcoholic Steatohepatitis (NASH)
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
- Being tested
- Atorvastatin, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
40 mg daily administered orally in tablet or capsule form
PlaceboDrug
Administered daily orally in tablet or capsule form, contains no active medicine
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Atorvastatin Treatment | Experimental | Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 96 weeks
Secondary outcomes (8)
NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....
Histological change from NASH to No NASH
Measured: Baseline, 96 weeks
Change in fibrosis stage as measured by change in stage
Ordinal variable
Measured: 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.
Measured: Baseline, 96 weeks
Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations
Measured: Baseline, 96 weeks
Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan®)
Measured: Baseline, 96 weeks
Change in capture attention parameter (CAP) score (with Fibroscan®)
Measured: Baseline, 96 weeks
Serum creatine phosphokinase (CPK) as measured by serum concentration
Measured: Baseline, 96 weeks
Change in serum lipids as measured by serum concentration
Measured: Baseline, 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start25 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal F. Abdelmalek, Mayo Clinic
- Investigators
- Manal Abdelmalek, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679376
- Sponsor's protocol ID
- 22-007824
- Acronym
- STAT NASH
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Statins in Adult Patients With Non-Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT04679376
- Acronym / sponsor ID
- STAT NASH / 22-007824
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Atorvastatin Treatment | Experimental | Drug: AtorvastatinSubjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks |
| Group 2: Placebo | Placebo comparator | Drug: PlaceboSubjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive a placebo for 96 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor40 mg daily administered orally in tablet or capsule form | Drug | Group 1: Atorvastatin Treatment |
| PlaceboAdministered daily orally in tablet or capsule form, contains no active medicine | Drug | Group 2: Placebo |
Primary outcome
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).
Time frame: Baseline, 96 weeks
One overall score of NASH improvement will be derived from improvement in NAS score OR no worsening in fibrosis.
8 secondary outcomes
NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....
Time frame: Baseline, 96 weeks
Change in fibrosis stage as measured by change in stage
Time frame: 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.
Time frame: Baseline, 96 weeks
Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations
Time frame: Baseline, 96 weeks
Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan®)
Time frame: Baseline, 96 weeks
Change in capture attention parameter (CAP) score (with Fibroscan®)
Time frame: Baseline, 96 weeks
Serum creatine phosphokinase (CPK) as measured by serum concentration
Time frame: Baseline, 96 weeks
Change in serum lipids as measured by serum concentration
Time frame: Baseline, 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Abdelmalek, MD, MPH principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with NASH - Nonalcoholic Steatohepatitis, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Baseline, 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.