Phase 2 N=80 Randomized Quadruple-blind Treatment

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver · Nonalcoholic Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT04031729 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

May 2024

Primary outcome: Primary: Absolute Change in Intrahepatic Lipid Content, by 1H-MRS — -6.6; 3.6 Mean absolute percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aspirin 81 mg (Drug); Placebo oral tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change in Intrahepatic Lipid Content, by 1H-MRS	-6.6; 3.6	—
SECONDARY Relative Change in Intrahepatic Lipid Content	-8.8; 30.0	—

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).

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

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Data sourced from ClinicalTrials.gov (NCT04031729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.