Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Phase 1

Completed

• Conditions: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis
• Interventions: Drug: Placebo oral tablet; Drug: Aspirin 81 mg

• Registration Number: NCT04031729
• Lead Sponsor: Massachusetts General Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Study Start: 2019-09-12
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Results First Submitted: 2024-03-22
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Results First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	Placebo tablets
Aspirin	Aspirin 81 mg	Low-dose (81mg) aspirin tablets

Primary Outcome Measures

Name	Time	Method
Absolute Change in Intrahepatic Lipid Content, by 1H-MRS	6 months	Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS

Secondary Outcome Measures

Name	Time	Method
Relative Change in Intrahepatic Lipid Content	6 months	Relative percentage point change in intrahepatic lipid content

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States