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

Enrolling by invitation

Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), MetALD

In brief

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.

Key facts

Study ID

NCT06986447

Run by

HRI-MAIL-NIT

People needed

1689

Starts

2025-10-25

Expected to finish

2029-06-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• 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:
• a. 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.
• e. HCV eradication by antiviral treatment less than three years prior to Screening.
• f. 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:
• a. 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

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• Arizona Liver Health — Peoria, Arizona, United States
• Arizona Liver Health — Tucson, Arizona, United States
• CRIOH — Westlake, Ohio, United States
• Houston Research Institute - Medical Center — Houston, Texas, United States
• Houston Research Institute - Dairy Ashford — Houston, Texas, United States
• Houston Research Institute - Pasadena — Pasadena, Texas, United States
• Houston Research Institute - Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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