Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic; University of Virginia
• Collaborator: AstraZeneca

Criteria

Inclusion Criteria:

• Age: 21-75

• Body Mass Index (BMI) >19 kg/m^2

• Subjects with biopsy/MRE proven NASH [MRS liver fat ≥ 5%, with elevated liver enzymes ALT <5x upper limit normal (ULN)].

• Subjects with NAFLD and MRE shows F0 or greater fibrosis

• Subjects with history suggestive of NAFLD/NASH

• Total bilirubin must be < 1.5 x ULN and INR must be < 1.3 at baseline screening.

• TSH and CPK will be within normal limits (WNL) at screening.

• 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.

• Hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females.

Exclusion Criteria:

• 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 American Diabetes Association (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.

• Subjects taking TZD's, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum and Valeriana officinalis.