NCT06935994 Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
| NCT ID | NCT06935994 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Metabolic Dysfunction Associated Steatotic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-05-05 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Teng-Yu Lee, MD, MBA, PhD
STUDY CHAIR
Taichung Veterans General Hospital
Frequently Asked Questions
Who can join the NCT06935994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metabolic Dysfunction Associated Steatotic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06935994 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06935994 currently recruiting?
Yes, NCT06935994 is actively recruiting participants. Contact the research team at tylee@vghtc.gov.tw for enrollment information.
Where is the NCT06935994 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06935994 clinical trial?
NCT06935994 is sponsored by Taichung Veterans General Hospital. The principal investigator is Teng-Yu Lee, MD, MBA, PhD at Taichung Veterans General Hospital. The trial plans to enroll 120 participants.