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Aspirin 81 mg for Nonalcoholic Fatty Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nonalcoholic Fatty Liver Disease+1 MoreAspirin 81 mg - Drug
Eligibility
18 - 69
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether or not aspirin can help reduce the amount of fat in the liver for people with nonalcoholic fatty liver disease, a condition that affects 30% of adults in the US.

Eligible Conditions
  • Nonalcoholic Fatty Liver Disease
  • Non-Alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Aspirin 81 mg
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OA-235i (4-30 mg)
1
Intervention/ Drug

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6 months

6 months
Concentrations of circulating bioactive lipid mediators
Percent intrahepatic lipid content, quantified by 1H-MRS

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Aspirin 81 mg
1
OA-235i (4-30 mg)
1
Intervention/ Drug

Side Effects for

Aspirin >300 mg
4%Nose bleeds
2%MI
2%TIA
This histogram enumerates side effects from a completed 2011 Phase 2 & 3 trial (NCT01586975) in the Aspirin >300 mg ARM group. Side effects include: Nose bleeds with 4%, MI with 2%, TIA with 2%.

Trial Design

2 Treatment Groups

Aspirin
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Aspirin 81 mg · Has Placebo Group · Phase 1 & 2

Aspirin
Drug
Experimental Group · 1 Intervention: Aspirin 81 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,128 Total Patients Enrolled
Tracey G Simon, MD, MPHPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18 - 69 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are aged 18 to 69 years.

Who else is applying?

What state do they live in?
Massachusetts33.3%
Connecticut33.3%
Arkansas33.3%
How old are they?
65+66.7%
18 - 6533.3%
What site did they apply to?
Massachusetts General Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria33.3%
Did not meet criteria66.7%
References

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