A Study of the Use of a New Drug in People with Non-Alcoholic Steatohepatitis (NASH) or Non-Alcoholic Fatty Liver Disease (NAFLD)

Overview

About this study

The purpose of this study is to assess a new drug to decrease liver fat in subjects with Non-Alcoholic Steatohepatitis or Non-Alcoholic Fatty Liver Disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age: 21-75 years old.
  • Body Mass Index (BMI) >19kg/m2.
  • Subjects with biopsy/MRE proven NASH [MRS liver fat ≥ 5%.
  • Total bilirubin (TB) must be < 1.5 x ULN and INR must be < 1.3 at baseline screening.
  • Hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females.
  • Subjects with previous biopsy proven and/or MRE proven NASH will be included.
  • Subjects with NAFLD and MRE shows F0 or greater fibrosis.
  • Subjects with history suggestive of NAFLD/NASH per recent guidelines published by Loomba et al (66).
  • Glucose tolerance status will be determined by OGTT.
  • TSH and CPK will be within normal limits (WNL) at screening.
  • Thyroid medications, statins and antihypertensive medications that are metabolically neutral (e.g., low dose thiazides) will be permitted.
  • Subjects with type 2 diabetes who are on stable doses of medications (except pioglitazone) to control hyperglycemia and have baseline HbA1c of 10% or lower.
  • No chronic medical condition including hepatic disease, stroke, Alzheimer’s disease, alcoholism or  increased alcohol consumption over the ADA guidelines or any disorder that may potentially impact the outcome measures.
  • Drugs potentially associated with non-alcoholic fatty liver disease (NAFLD) such as amiodarone, methotrexate, perhexiline, estrogens, tamoxifen, nifedipine, diltiazem, choloroquine and other hepatotoxic agents will need to be reviewed if used for more than 2 consecutive weeks in the 2 years preceding the screen visit.
  • Additionally, if subjects are taking drugs such Vit E, Ursodeoxycholic acid, Gemfibrozil, anti TNF therapies and probiotics will be allowed if on stable doses in the preceding 2 weeks and continued throughout the study. However as with all concomitant medication usage the study doctors will review on case by case basis prior to inclusion in trial. The final decision for enrollment will be based on the clinical judgement, discretion of the study doctors.

Exclusion Criteria:

  • Subjects taking TZD’s, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum and Valeriana officinalis.
  • Medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates, and anticoagulants.
  • Subjects with anemia, and symptoms suggestive of undiagnosed illness, overt hepatic disease, stroke, Alzheimer's disease, autoimmune hepatitis, alcoholism or increased alcohol consumption over the ADA guidelines.
  • Any disorder that may potentially impact the outcome measures.
  • Pregnant women and children.
  • Subjects planning weight loss or in any weight loss program.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

A.J. Vinaya Simha, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Kelly Dunagan R.N.

(507) 422-6696

Dunagan.Kelly@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20167651

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