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

NCT02605616

TerminatedPhase 2

Sponsor: University of Alabama at Birmingham

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)

Interventions: AZ compound, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 21 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age: 21-75
* Body Mass Index (BMI) \>19 kg/m\^2
* Subjects with biopsy/MRE proven NASH \[MRE liver fat ≥ 5%, with elevated liver enzymes ALT \<5x upper limit normal (ULN)\].
* 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.

Locations (1)

Charlottesville, Virginia, United States