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Study of Resmetirom in Children and Adolescents With MASH

StatusRecruiting
PhasePhase 2
Started2026-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
notable
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-08→confirmed 2026-08-01
Study sitesdetails revised at 1 of 1 site
2026-08-10
minor
Original filing
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.
Trial Details
NCT Number NCT07763015
Lead Sponsor Madrigal Pharmaceuticals, Inc.
Conditions MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 61 participants
Start Date 2026-08-01
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-11