RECRUITING

Statins for the Treatment of NASH

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2023-01-25

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04679376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Christopher Kigongo

CONTACT

507-266-1998

Kigongo.Christopher@mayo.edu

Amy Olofson

CONTACT

507-538-6547

Olofson.Amy@mayo.edu

Principal Investigator

Manal Abdelmalek, MD, MPH

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Manal Abdelmalek, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-25

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-01-25

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

NASH - Nonalcoholic Steatohepatitis