drugset / Trial / NCT04031729

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

NCT04031729 ↗

Phase 1/2 Completed 80 enrolled Massachusetts General Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2019-09-12
Primary completion
2023-02-23
Completion
2023-02-23

Outcome

Met primary endpoint

paper mean absolute change in hepatic fat content by MRS was -6.6% with aspirin vs 3.6% with placebo (difference, -10.2% [95% CI, -27.7% to -2.6%]; P = .009). PMID 38502074 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg —