Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT06935994 | Recruiting Phase 2 DMC

• 1 other identifier: CF24404A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (2)

• Mean absolute change of VCTE-estimated LSM

  The surrogate primary endpoint is mean absolute change of VCTE-estimated LSM (kPa).

  Week 48

• 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.

  Week 240

Secondary Outcomes (4)

• Mean percentage change of VCTE-estimated LSM

  Week 48, Week 240

• Changes in hepatic fat fraction

  Week 48, Week 240

• Mean absolute changes of serum AST/ ALT

  Week 48, Week 240

• Mean percentage changes of serum AST/ ALT

  Week 48, Week 240

Study Arms (2)

Aspirin arm

ACTIVE COMPARATOR

Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo

Drug: Aspirin 81 mg Enteric Coated Tab - 1 tablet

Placebo arm

PLACEBO COMPARATOR

Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo

Drug: Placebo

Interventions

Aspirin 81 mg Enteric Coated Tab - 1 tablet DRUG

Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo

Also known as: Un-impede E.F.C.

Aspirin arm

Placebo DRUG

Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo

Also known as: Placebo Tablet

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria

You may not qualify if:

• 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)
• Liver cirrhosis with significant portal hypertension (platelet count \< 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices)
• High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening
• Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening
• FIB-4 index \< 1.3 at screening
• Indicated for any anti-platelet therapy, such as history of cardiovascular events
• History of aspirin allergy
• History of bleeding disorders, such as hemophilia
• Pregnancy or breast feeding
• Severe renal impairment, which is defined as eGFR \< 30 mL/min/1.73 m²
• Any malignancies

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Teng-Yu Lee, MD, MBA, PhD

  Taichung Veterans General Hospital

  STUDY CHAIR

Central Study Contacts

Teng-Yu Lee, MD, MBA, PhD

CONTACT

+886423592525; tylee@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 20, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)