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Metabolic Dysfunction-Associated Steatotic Liver DiseaseMAIL-NITNCT06986447

Assessment of Non-Invasive Testing in Major Liver-Related Outcomes

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by HRI-MAIL-NIT at 8 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a general clinical research protocol to study the clinical evaluation, investigation and long-term follow up of patients who have Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and MetALD (MASLD and increased alcohol intake), and to assess the usefulness and accuracy of non-invasive testing… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
1,689 participants
Where
8 sitesUnited States
Study dates
25 Oct 2025to Jun 2029
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants in this study will be recruited solely from the clinical practices of the participating sites.

Who may be able to join

  • -
  • Adults, 18-80, male or female.
  • Cohort A (MASH): Evidence of MASH (metabolic dysfunction-associated steatohepatitis) with fibrosis stage 3 or higher based on MRE stiffness of >3.63 kPa or liver biopsy.
  • Cohort B (MetALD): Evidence of MetALD/ALD as defined by the AASLD nomenclature criteria and evidence of liver stiffness of 12 kPa or higher on VCTE.
  • Willingness to participate in the study. Exclusion criteria
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  • Involvement in the planning and/or conduct of the study (including sponsors, clinic staff, and vendors)
  • Participation in another clinical study with intake of an investigational product during the last 60 days prior to Baseline
  • Participation in a large multinational observational cohort (local registry and biobank are allowed) Target disease exclusions
  • History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to baseline (For Cohort A only).
  • MELD score ≥12, as determined at baseline, due to liver disease.
  • Evidence of current, chronic liver diseases at the time of baseline:
  • Primary biliary cholangitis b. Primary sclerosing cholangitis c. Chronic hepatitis B or D d. Hepatitis C, as defined by the presence of hepatitis C virus antibody (anti-HCV) with detected circulating ribonucleic acid (RNA) within two years prior to Screening, or during Screening Period.
  • HCV eradication by antiviral treatment less than three years prior to Screening.
  • History or evidence of current active autoimmune hepatitis g. History or evidence of Wilson's disease h. History or evidence of alpha-1-antitrypsin deficiency i. Evidence of genetic hemochromatosis (hereditary, primary) j. Evidence of drug-induced liver disease k. Known bile duct obstruction. l. Suspected or proven hepatocarcinoma, or metastatic tumor in the liver
  • Evidence of hepatic impairment or decompensation within 3 months prior to baseline, as defined by any of the following parameters:
  • History of ascites, or hepatic encephalopathy b. History of variceal bleeding c. Serum albumin < 3.5 g/dL, except as explained by non-hepatic causes. d. International Normalized Ratio (INR) ≥ 1.3, except for participants under anticoagulant treatment.
  • o NOTE: INR may be repeated once to reassess eligibility e. Total bilirubin (TBL) ≥ 1.5 ULN
  • o NOTE: Patients with Gilbert's Syndrome are eligible with a total bilirubin above 1.5 × ULN if reticulocyte count is within normal limits (typically 0.5% to 2.5%), hemoglobin is within normal limits (typically 13.5 to 17.5 g/dL for men or 12.0 to 15.5 g/dL for women), and direct bilirubin is <20% of total bilirubin f. Platelet count < 110,000/mm3
  • Prior history of medium or large varices
  • Bariatric surgery of any kind within 2 years prior to the baseline visit Medical History and Concurrent Disease Exclusions Cardiovascular diseases
  • Any of the following diseases or procedures within 24 weeks prior to baseline:
  • Myocardial infarction (MI)
  • Cardiac revascularization surgery (coronary artery bypass graft / percutaneous transluminal coronary angioplasty (CABG / PTCA))
  • Unstable angina
  • Transient ischemic attack, stroke or cerebrovascular disease Hematological and oncological diseases
  • Active malignancy with a complete remission date within 2 years prior to the baseline visit (except for treated basal cell carcinoma or treated squamous cell carcinoma of the skin or resected carcinoma of the cervix) Other exclusion conditions
  • Immunocompromised participants such as participants that underwent organ transplantation or are diagnosed with human immunodeficiency virus (HIV) or participants with ongoing chemotherapy for stable malignant disease (such as a PD-1 inhibitor)
  • Any other known serious disease (such as major infection, clinically significant gastrointestinal disorder, major autoimmune disease) or other disease which in the Investigator's opinion would exclude the participant from the study.
  • Mental handicap, limited capacity of recognition, inability to follow the study procedures as evaluated by the Investigator, or any history of clinically important emotional and/or psychiatric illness.
  • Use of non-permitted concomitant medication within 8 weeks prior to the initial baseline visit (A transient intake < 4 weeks may be allowed after approval of the Medical Monitor)
  • Vitamin E >400 units per day. Participants on stable vitamin E therapy (same doses) for the last 12 weeks prior to baseline are eligible but the therapy should be maintained at stable dose throughout the study
  • Pioglitazone >15 mg per day. Participants on stable pioglitazone therapy (same doses) for the last 12 weeks prior to baseline are eligible but the therapy should be maintained at stable dose throughout the study
  • GLP1-RA, SGLT2-I unless on stable doses for the last 12 weeks prior to baseline
  • Amiodarone within 12 months of enrollment
  • Methotrexate within 12 months of enrollment
  • Chronic use (> 2 consecutive weeks) of corticosteroids with a systemic effect at doses ≥ 5 mg/day of oral prednisone (or equivalent)
  • Tamoxifen within 12 months of enrollment
  • Estrogens at doses greater than those used for hormone replacement or contraception
  • Anabolic steroids except testosterone replacement
  • Valproic acid
  • Any other medications known to affect liver function/steatosis at the Investigator's discretion (including vitamins, herbal and dietary supplements)
  • Contraindications to MRI, including:
  • Participants with incompatible pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field
  • History of extreme claustrophobia
  • The participant cannot fit inside the magnetic resonance scanner cavity

Who cannot join

  • -

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites

  • Arizona Liver Health

    Chandler, Arizona, 85224

  • Houston Research Institute - Medical Center

    Houston, Texas, 77030

  • Houston Research Institute - Dairy Ashford

    Houston, Texas, 77079

  • Houston Research Institute - Pasadena

    Pasadena, Texas, 77505

  • Arizona Liver Health

    Peoria, Arizona, 85381

  • Houston Research Institute - Sugar Land

    Sugar Land, Texas, 77478

  • Arizona Liver Health

    Tucson, Arizona, 85712

  • CRIOH

    Westlake, Ohio, 44145

Other trials in United States

About this study

Official title: MASH/MetALD Consortium for the Assessment of Non-Invasive Testing in Monitoring Interventions, Treatment Response, and Major Liver-Related Outcomes

This is a general clinical research protocol to study the clinical evaluation, investigation and long-term follow up of patients who have Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and MetALD (MASLD and increased alcohol intake), and to assess the usefulness and accuracy of non-invasive testing such as MRI and Fibroscan in tracking the progression of disease. The protocol is designed to follow the natural history, pathogenesis, interventions, treatment response, comorbidities, major liver related outcomes, and major cardiac events in patients with MASLD and MetALD, especially those with significant and advanced fibrosis. Data will be collected to help further the understanding of non-invasive testing with the hopes of lessening the need for liver biopsies in phase 3 clinical trials of MASLD and in clinical practice. Additionally, the study will aim to define the natural history of MetALD, an area that is poorly understood.

Keywords
MASLD, MetALD, Non-invasive testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06986447
Study groupRoleWhat they receive
MASLD (Cohort A)Patients with metabolic dysfunction-associated steatotic liver disease
MetALD (Cohort B)Patients with metabolic dysfunction-associated steatotic liver disease and increased alcohol intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of major adverse liver outcomes (MALO)

    Variceal bleeding, hepatic encephalopathy, ascites, progression from MELD 13 to 15, liver transplant, death attributable to liver disease, progression to large varices

    Measured: 2 years

Secondary outcomes (1)

  1. Major adverse cardiovascular events (MACE)

    Fatal or non-fatal MI, fatal or non-fatal stroke, death attributable to cardiovascular disease

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start25 Oct 2025
  3. Primary completionFeb 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,689 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06986447
Sponsor's protocol ID
MAIL-NIT
Acronym
MAIL-NIT
Status last verified
Mar 2026
First submitted
15 May 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by HRI-MAIL-NIT at 8 sites in United States.

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 46 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of major adverse liver outcomes (MALO) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06986447.

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 27 Mar 2026.

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