Health TrialsbyHealthPanel

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

ConditionMASH - Metabolic Dysfunction-Associated Steatohepatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMadrigal Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF

Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF

Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.

MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.

Disqualifiers

Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.

Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.

FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa.

Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resmetirom

    Drug

    Randomized 80 or 100 mg

  • Placebo

    Drug

    Placebo

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1Active comparator 1 intervention
Group B: Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2Active comparator 1 intervention
Group C: Arm 3: Placebo - Cohort 1Placebo comparator 1 intervention
Group D: Arm 4: Placebo - Cohort 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28

To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.

Time frame
28 weeks

Secondary outcomes

1

To evaluate the safety and tolerability of once-daily, oral administration of MGL-3196/resmetirom versus matching placebo in patients who have undergone a liver transplant

Time frame
52 weeks
2

1.To determine the effect of MGL-3196/resmetirom versus matching placebo on liver stiffness as measured by FibroScan vibration controlled transient elastography (VCTE; kPa)

Absolute change and percent change from Baseline to Week 28 and Week 52 on FibroScan VCTE

Time frame
28 and 52 Weeks
3

2. To determine the effect of MGL-3196/resmetirom versus matching placebo on serum lipid parameters

Absolute and percent change from Baseline to Week 28 and Week 52 in LDL-C, lipoprotein A \[Lp(a)\] in patients with baseline Lp(a) \>10 nmol/L and triglycerides (TGs) in patients with baseline TGs \>150 mg/dL

Time frame
28 and 52 Weeks
4

3. To determine the effect of MGL-3196/resmetirom versus matching placebo on liver biochemistries

Absolute and percent change from baseline in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma glutamyl transferase (GGT), at Week 28 and Week 52

Time frame
28 and 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Madrigal Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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