Back to resultsAspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Primary Purpose
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Fatty Liver focused on measuring Aspirin, Liver Disease, Anti-inflammatory
Eligibility Criteria
Inclusion Criteria:
- Ages 18 to 69 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 2 (F2), 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 > 2
- Current aspirin use
- Contraindications to aspirin use
- Contraindications to magnetic resonance imaging (MRI)
- Pregnancy or desire to become pregnant
- Breastfeeding
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aspirin
Placebo
Arm Description
Low-dose (81mg) aspirin tablets
Placebo tablets
Outcomes
Primary Outcome Measures
Percent intrahepatic lipid content, quantified by 1H-MRS
Secondary Outcome Measures
Concentrations of circulating bioactive lipid mediators
Full Information
NCT ID
NCT04031729
First Posted
July 22, 2019
Last Updated
August 8, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04031729
Brief Title
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Official Title
Aspirin in Adults With Nonalcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Keywords
Aspirin, Liver Disease, Anti-inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Low-dose (81mg) aspirin tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Intervention Description
Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Primary Outcome Measure Information:
Title
Percent intrahepatic lipid content, quantified by 1H-MRS
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Concentrations of circulating bioactive lipid mediators
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey G Simon, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
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