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Nonsteroidal Anti-inflammatory Drug

Aspirin 81 mg for Non-alcoholic Fatty Liver Disease

Phase 1 & 2
Waitlist Available
Led By Tracey G Simon, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing whether aspirin can help reduce fat in the liver for adults with Nonalcoholic Fatty Liver Disease (NAFLD). NAFLD can lead to serious liver problems, and current treatments are limited. Aspirin might work by reducing inflammation and affecting fat storage in the liver. Recent studies have found new uses for aspirin in treating NAFLD, but human studies are still limited.

Eligible Conditions
  • Fatty Liver Disease
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change in Intrahepatic Lipid Content, by 1H-MRS
Secondary study objectives
Relative Change in Intrahepatic Lipid Content

Side effects data

From 2011 Phase 2 & 3 trial • 93 Patients • NCT01586975
6%
Nose bleeds
3%
GI bleeding
3%
Clinical Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin 81 mg
Aspirin >300 mg
Clopidogrel 75 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
Low-dose (81mg) aspirin tablets
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 81 mg
2019
Completed Phase 4
~1070

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,231 Total Patients Enrolled
15 Trials studying Non-alcoholic Fatty Liver Disease
776 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Tracey G Simon, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
~13 spots leftby Nov 2025
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