NCT02605616

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

A Randomized, Double-Blinded, Placebo-controlled Phase IIa Study to Assess the Efficacy and Safety of a Novel AstraZeneca Compound in Subjects With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

We propose to evaluate hepatic fat and hepatic fibrosis using magnetic resonance elastography (MRE) liver (pre vs. post). We will also establish glucose tolerance status by our established labeled oral glucose tolerance test (OGTT) (6,6 ²H2 glucose). Following baseline evaluation subjects with biopsy/MRE proven NASH will be randomized to one of two groups and treated either with active drug (AZ compound) or placebo for 12 weeks (plus or minus 1 week). Subjects with history suggestive of non-alcoholic fatty liver disease (NAFLD) or NASH will be invited to participate. If they meet criteria following initial screening they will be included in the study. OGTT, liver MRE will be repeated. Liver enzymes \[aspartate aminotransferase (AST), alanine aminotransferase (ALT),alkaline phosphatase (ALP)\] as well as other safety tests \[creatine phosphokinase (CPK), thyroid stimulating hormone (TSH), international normalized ratio (INR),total bilirubin\] will be measured before, monthly during therapy and at one month following therapy. Furthermore, we will also do the subgroup analysis in NASH/NAFLD subjects with and without diabetes to see the effect of the drug.

Conditions

• Non-alcoholic Fatty Liver Disease (NAFLD)
• Non-alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	AZ compound	AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).
OTHER	Placebo	Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2015-11-16
• Last updated: 2024-03-01
• Results posted: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study