Aspirin treatment for liver disease related to metabolic dysfunction
Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
This study is testing if taking low-dose aspirin every day can help people with liver disease caused by metabolic issues feel better and slow down the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 1 site (Taichung, Taiwan) |
| Trial ID | NCT06935994 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term efficacy and safety of low-dose aspirin in patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will be randomly assigned to receive either daily low-dose aspirin or a placebo for 240 weeks. The study is designed as a double-blind, placebo-controlled trial to ensure unbiased results. The goal is to determine if aspirin can effectively reduce the progression of MASLD, which is a significant cause of chronic liver disease worldwide.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with MASLD and meet specific cardiometabolic criteria.
Not a fit: Patients with significant liver disease complications, such as cirrhosis or active peptic ulcer disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients suffering from MASLD, potentially reducing the risk of disease progression.
How similar studies have performed: Previous studies have suggested potential benefits of aspirin in treating MASLD, but this specific long-term randomized controlled trial is novel and has not been conducted before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or older 2. Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria Exclusion Criteria: 1. Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men) 2. Glycated hemoglobin (HbA1c) level ≥ 9.0% 3. Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc. 4. Liver decompensation (Child-Pugh class B or C) 5. Liver cirrhosis with significant portal hypertension (platelet count \< 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices) 6. High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening 7. Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening 8. FIB-4 index \< 1.3 at screening 9. Indicated for any anti-platelet therapy, such as history of cardiovascular events 10. History of aspirin allergy 11. History of bleeding disorders, such as hemophilia 12. Pregnancy or breast feeding 13. Severe renal impairment, which is defined as eGFR \< 30 mL/min/1.73 m² 14. Any malignancies
Where this trial is running
Taichung, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Teng-Yu Lee, MD, MBA, PhD
- Email: tylee@vghtc.gov.tw
- Phone: +886423592525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.