NCT04031729

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Aspirin in Adults With Nonalcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.
DRUG	Placebo oral tablet	Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Timeline

• Start date: 2019-09-12
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2019-07-24
• Last updated: 2024-05-24
• Results posted: 2024-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study