Metabolic Dysfunction Associated Steatotic Liver DiseasePhase 2NCT06935994
Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
A Phase 2 study testing Aspirin 81 mg Enteric Coated Tab - 1 tablet in people with Metabolic Dysfunction Associated Steatotic Liver Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction Associated Steatotic Liver Disease
- What is being tested?
- Aspirin 81 mg Enteric Coated Tab - 1 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2025to 31 Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Teng-Yu Lee, MD, MBA, PhD, 0423592525 ext. 3301, tylee@vghtc.gov.tw
About this study
Official title: Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Aspirin 81 mg Enteric Coated Tab - 1 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mg Enteric Coated Tab - 1 tabletDrug
Also called Un-impede E.F.C.
Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
PlaceboDrug
Also called Placebo Tablet
Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
| Study group | Role | What they receive |
|---|---|---|
| Aspirin arm | Active comparator | Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute change of VCTE-estimated LSM
The surrogate primary endpoint is mean absolute change of VCTE-estimated LSM (kPa).
Measured: 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.
Measured: Week 240
Secondary outcomes (4)
Mean percentage change of VCTE-estimated LSM
Mean percentage change of LSM measured by VCTE (%)
Measured: Week 48, Week 240
Changes in hepatic fat fraction
Mean change of hepatic fat fraction measured by MRS (%)
Measured: Week 48, Week 240
Mean absolute changes of serum AST/ ALT
Mean absolute changes of serum AST, ALT (U/L)
Measured: Week 48, Week 240
Mean percentage changes of serum AST/ ALT
Mean percentage changes of serum AST/ ALT (%)
Measured: Week 48, Week 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start5 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teng-Yu Lee, MD, MBA, PhD, Study chair, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935994
- Sponsor's protocol ID
- CF24404A
- Status last verified
- May 2025
- First submitted
- 6 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06935994
- Acronym / sponsor ID
- CF24404A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aspirin arm | Active comparator | Drug: Aspirin 81 mg Enteric Coated Tab - 1 tabletParticipants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo |
| Placebo arm | Placebo comparator | Drug: PlaceboParticipants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81 mg Enteric Coated Tab - 1 tabletAlso: Un-impede E.F.C.Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo | Drug | Aspirin arm |
| PlaceboAlso: Placebo TabletParticipants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo | Drug | Placebo arm |
Primary outcome
Mean absolute change of VCTE-estimated LSM
Time frame: Week 48
The surrogate primary endpoint is mean absolute change of VCTE-estimated LSM (kPa).
Cumulative incidence of MASLD-related clinical outcomes
Time frame: Week 240
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.
4 secondary outcomes
Mean percentage change of VCTE-estimated LSM
Time frame: Week 48, Week 240
Changes in hepatic fat fraction
Time frame: Week 48, Week 240
Mean absolute changes of serum AST/ ALT
Time frame: Week 48, Week 240
Mean percentage changes of serum AST/ ALT
Time frame: Week 48, Week 240
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teng-Yu Lee, MD, MBA, PhD study chair
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 81 mg Enteric Coated Tab - 1 tablet in people with Metabolic Dysfunction Associated Steatotic Liver Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teng-Yu Lee, MD, MBA, PhD (+886423592525 ext. 3301, tylee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute change of VCTE-estimated LSM (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.