Study of Resmetirom in Children and Adolescents With MASH

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Madrigal Pharmaceuticals, Inc.
Study ID
NCT07763015
Phase
PHASE2
Status
Recruiting
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Conditions

  • MASH
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Resmetirom — DRUG
    Resmetirom (MGL-3196) : Oral resmetirom administered once daily. Participants receive one of several protocol-defined dose levels assigned according to the sequential multiple ascending-dose study design. Dose escalation proceeds following review of available safety, pharmacokinetic, and pharmacodynamic data.

Study Details

This study will evaluate the safety, pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the drug), and pharmacodynamics (how the drug affects the body) of resmetirom in children and adolescents with metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis. Participants will receive oral resmetirom once daily for approximately 14 days at one of several dose levels. The information from this study will help determine appropriate dosing and further evaluate the safety and biological effects of resmetirom in pediatric participants with MASH.

Key Dates

First listed
Aug 13, 2026
Start date
Aug 1, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
61 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adolescent Dose-Escalation Cohort 1
    Adolescents participants 12 to 17 years of age receive the first planned dose level of oral resmetirom once daily for approximately 14 days
  • Experimental: Adolescent Dose-Escalation Cohort 2
    Adolescent participants 12 to 17 years of age receive the second planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Adolescent Dose-Escalation Cohort 3
    Adolescent participants 12 to 17 years of age receive the third planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Adolescent Dose-Escalation Cohort 4
    Adolescent participants 12 to 17 years of age receive the fourth planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Adolescent Dose-Escalation Cohort 5
    Adolescent participants 12 to 17 years of age receive the fifth planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Child Dose-Escalation Cohort 6
    Children participants 6 to 11 years of age receive the first planned dose level of oral resmetirom once daily for approximately 14 days.
  • Experimental: Child Dose-Escalation Cohort 7
    Children participants 6 to 11 years of age receive the second planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Child Dose-Escalation Cohort 8
    Children participants 6 to 11 years of age receive the third planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.
  • Experimental: Child Dose-Escalation Cohort 9
    Children participants 6 to 11 years of age receive the fourth planned dose level of oral resmetirom once daily for approximately 14 days following review of safety and PK data.

Primary Outcome Measure

Safety and tolerability of multiple ascending doses of resmetirom [ Time Frame: Baseline through approximately Day 21 (or the protocol-defined safety follow-up period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for Children at IU HealthIndianapolisIndiana46402-

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By research site
Riley Hospital for Children at IU Health· Indianapolis, IN

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