Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2032-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

NCT04031729

Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis

COMPLETED PHASE1/PHASE2

A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

NCT00668070

Non-Alcoholic Steatohepatitis

COMPLETED PHASE2

A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

NCT06836609

Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Dysfunction-Associated Steatohepatitis

RECRUITING PHASE1

A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

NCT05395481

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

ACTIVE_NOT_RECRUITING PHASE1

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

NCT06613698

Liver Diseases, Alcoholic

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Metabolic dysfunction-associated steatotic liver disease (MASLD) has become one of the most common chronic liver diseases, with an estimated prevalence exceeding 30% globally. MASLD can result in liver cirrhosis, hepatocellular carcinoma (HCC), and death, and it has become the leading cause of HCC waiting for liver transplantation in the U.S. Unfortunately, although several new drugs put forth in clinical trials have been shown to offer certain benefits towards improving MASLD, an effective medicine remains lacking. With the limitations in efficacy and safety issues, even though some medications maybe hopeful in the treatments for MASLD, more medical choices remain highly expected. Emerging laboratory evidence suggests that antiplatelet therapy, e.g., aspirin, can reduce the risk of MASLD progression; however, a well-designed clinical trial should be mandatory before its clinical use. A recently published 6-month, phase 2 randomized controlled trial (RCT) demonstrated that daily aspirin might improve MASLD, but several limitations of this study should be further investigated. Therefore, we aim to conduct a RCT to evaluate the long-term effect of low-dose aspirin therapy on MASLD. This phase 2, double-blind, randomized, placebo-controlled trial will recruit MASLD patients, who fulfill the inclusion and exclusion criteria of this study. Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo for 240 weeks. Participants will be follow-up at outpatient clinics every 12 weeks, and liver stiffness measurement (LSM) will be evaluated by using vibration-controlled transient elastography (VCTE). The surrogate primary endpoint is mean absolute change of VCTE-estimated liver stiffness at week 48. The clinical- outcome primary endpoint is MASLD-related outcomes (LSM progression \>= 5 kPa, liver decompensation, HCC development, cardiovascular events, and death) at week 240. The secondary endpoints include mean absolute changes of hepatic fat fraction measured by 1H-MR spectroscopy and liver function parameters and the cumulative incidence of bleeding events. Additionally, the study will explore associations between stool microbiota/ MASLD-related single nucleotide polymorphisms, such as PNPLA3, TM6SF2, MBOAT7 genes, and clinical outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Dysfunction Associated Steatotic Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This phase 2, double-blind, randomized, placebo-controlled trial will recruit MASLD patients, who fulfill the inclusion and exclusion criteria of this study, at Taichung Veterans General Hospital. Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo for 240 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.