Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Official Title
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Aspirin in Adults With Nonalcoholic Fatty Liver Disease

Conditions
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Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: Aspirin 81 mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 to 70 years NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit. Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit. Exclusion Criteria: Liver fibrosis stage > 3 Current aspirin use Contraindications to aspirin use Contraindications to magnetic resonance imaging (MRI) Pregnancy or desire to become pregnant Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Low-dose (81mg) aspirin tablets | Drug: Aspirin 81 mg<br>* Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.<br>|
| Placebo Comparator: Placebo<br>Placebo tablets | Drug: Placebo oral tablet<br>* Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent intrahepatic lipid content, quantified by 1H-MRS |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of circulating bioactive lipid mediators |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Liver Disease, Anti-inflammatory