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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
HRI-MAIL-NIT
Study ID
NCT06986447
Status
Enrolling By Invitation

Conditions

  • MASLD
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Oct 25, 2025
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
1,689 participants (estimated)

Arms

  • Arm: MASLD (Cohort A)
    Patients with metabolic dysfunction-associated steatotic liver disease
  • Arm: MetALD (Cohort B)
    Patients with metabolic dysfunction-associated steatotic liver disease and increased alcohol intake

Primary Outcome Measure

Occurrence of major adverse liver outcomes (MALO) [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224-
Arizona Liver HealthPeoriaArizona85381-
Arizona Liver HealthTucsonArizona85712-
CRIOHWestlakeOhio44145-
Houston Research Institute - Dairy AshfordHoustonTexas77079-
Houston Research Institute - Medical CenterHoustonTexas77030-
Houston Research Institute - PasadenaPasadenaTexas77505-
Houston Research Institute - Sugar LandSugar LandTexas77478-

Find similar trials in Chandler, AZ

By research site
Arizona Liver Health· Chandler, AZArizona Liver Health· Peoria, AZArizona Liver Health· Tucson, AZCRIOH· Westlake, OHHouston Research Institute - Dairy Ashford· Houston, TXHouston Research Institute - Medical Center· Houston, TX

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