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OpenTrials
Completed

NCT Number: NCT04031729

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

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).

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Key information

Conditions

Nonalcoholic Fatty Liver Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 81 mg

Drug

Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.

Placebo oral tablet

Drug

Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Primary outcomes

  1. Absolute Change in Intrahepatic Lipid Content, by 1H-MRS

    Time frame: 6 months

    Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS

Secondary outcomes

  1. Relative Change in Intrahepatic Lipid Content

    Time frame: 6 months

    Relative percentage point change in intrahepatic lipid content

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Aspirin in Adults With Nonalcoholic Fatty Liver Disease

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2019
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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