Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of chronic liver disease worldwide and a significant public health issue. MASLD may progress to liver cirrhosis and/or hepatocellular carcinoma. Although previous evidence suggests that aspirin has antisteatotic and antifibrotic effects on the liver, a randomized controlled trial assessing long-term efficacy and safety of aspirin in MASLD patients has yet to be conducted. This study aims to conduct a randomized controlled trial to evaluate the efficacy of aspirin in treating MASLD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Disqualifiers
Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men)
Glycated hemoglobin (HbA1c) level ≥ 9.0%
Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc.
Liver decompensation (Child-Pugh class B or C)
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin 81 mg Enteric Coated Tab - 1 tablet
DrugParticipants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Placebo
DrugParticipants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Aspirin armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean absolute change of VCTE-estimated LSM
The surrogate primary endpoint is mean absolute change of VCTE-estimated LSM (kPa).
Time frame
Week 482
Cumulative incidence of MASLD-related clinical outcomes
The clinical-outcome primary endpoint is the cumulative incidence (%) of any MASLD-related adverse outcomes, including LSM progression \>= 5 kPa, liver decompensation, HCC development, cardiovascular events, and death.
Time frame
Week 240Secondary outcomes
1
Mean percentage change of VCTE-estimated LSM
Mean percentage change of LSM measured by VCTE (%)
Time frame
Week 48, Week 2402
Changes in hepatic fat fraction
Mean change of hepatic fat fraction measured by MRS (%)
Time frame
Week 48, Week 2403
Mean absolute changes of serum AST/ ALT
Mean absolute changes of serum AST, ALT (U/L)
Time frame
Week 48, Week 2404
Mean percentage changes of serum AST/ ALT
Mean percentage changes of serum AST/ ALT (%)
Time frame
Week 48, Week 240Sponsors and contacts
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Source ClinicalTrials.gov