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

NCT06986447 | Enrolling By Invitation DMC

• 1 other identifier: MAIL-NIT
• Study Type: observational
• Target: 1,689
• Locations: 1 country
• Sites: 8

Brief 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 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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis); MetALD; Metabolic Dysfunction-Associated Steatotic Liver Disease; MASLD

Keywords

MASLD; MetALD; Non-invasive testing

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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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
• 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
• Any of the following diseases or procedures within 24 weeks prior to baseline:

Sponsors & Collaborators

• HRI-MAIL-NIT: lead

Study Sites (8)

Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health

Peoria, Arizona, 85381, United States

Location

Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

CRIOH

Westlake, Ohio, 44145, United States

Location

Houston Research Institute - Medical Center

Houston, Texas, 77030, United States

Location

Houston Research Institute - Dairy Ashford

Houston, Texas, 77079, United States

Location

Houston Research Institute - Pasadena

Pasadena, Texas, 77505, United States

Location

Houston Research Institute - Sugar Land

Sugar Land, Texas, 77478, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum and plasma samples

Study Officials

• Mazen Noureddin, MD, MHSc

  Houston Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (8)