Aspirin treatment for liver disease related to metabolic dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Health profile of MASLD in Kazakhstan and real-world use of Ursosan in Almaty

  This study tests how MASLD appears in adults in Kazakhstan and how Ursosan is used in real-world care for a subgroup in Almaty.

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• Endohepatology-based reclassification of treatment indication in high-risk MASLD

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• ALN-CIDEB in adults with MASLD to see if it helps the liver

  This study tests whether ALN-CIDEB can help adults with MASLD and its liver damage compared to placebo.

  Recruiting at 4 sites Phase 3 Regeneron Pharmaceuticals · Miami, Florida and 3 other locations · NCT07854782

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

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  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Taiwan green propolis for MASLD and lipid/metabolic issues

  This study tests whether Taiwan green propolis capsules can improve blood lipids and body fat in adults with MASLD compared to a placebo over 12 weeks.

  Recruiting Taipei Medical University · Dalin · NCT07692438

• Secukinumab retention in adults with plaque psoriasis and MASLD in Spain

  This study tests how long people with plaque psoriasis and MASLD stay on secukinumab in real-world Spain, using EMR data from several hospitals.

  Recruiting at 9 sites Novartis · Badalona, Barcelona and 8 other locations · NCT07683065

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.