Status:
RECRUITING
Statins for the Treatment of NASH
Lead Sponsor:
Mayo Clinic
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04679376
Start Date
January 25 2023
End Date
December 1 2026
Last Update
February 5 2025
Active Locations (2)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
2
Duke University Medical Center
Durham, North Carolina, United States, 27710