Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH

Part of paid clinical trials in La Jolla, California.

Sponsor
Madrigal Pharmaceuticals, Inc.
Study ID
NCT07335601
Phase
PHASE2
Status
Recruiting
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Conditions

  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Resmetirom — DRUG
    Randomized 80 or 100 mg
  • Placebo — DRUG
    Placebo

Study Details

A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.

Key Dates

Start date
Dec 29, 2025
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1
  • Active Comparator: Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2
  • Placebo Comparator: Arm 3: Placebo - Cohort 1
  • Placebo Comparator: Arm 4: Placebo - Cohort 2

Primary Outcome Measure

Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28 [ Time Frame: 28 weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037-
University of California Los Angeles Medical CenterLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of ColoradoAuroraColorado80045-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007
[email protected]
(202) 444-2000
Northwestern UniversityChicagoIllinois60208
Cheung, PI
[email protected]
312-694-1293
The University of Chicago MedicineChicagoIllinois60637-
Mayo ClinicRochesterMinnesota55905-
University of NebraskaOmahaNebraska68198-2000
[email protected]
402-559-4000
Northwell Health Inc, Center for Liver Disease and TransplantationManhassetNew York11030-
New York Presbyterian HospitalNew YorkNew York10065-
Vanderbilt University Medical Center (VUMC)NashvilleTennessee37212-
Dallas MethodistDallasTexas75203-
Houston Methodist HospitalHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAUniversity of California Los Angeles Medical Center· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Colorado· Aurora, COMedstar Georgetown University Hospital· Washington D.C., DCNorthwestern University· Chicago, IL

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