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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07830758). This is a study registration, not published results. Lead sponsor: Madrigal Pharmaceuticals, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis, Heart Failure With Preserved Ejection Fraction (HFPEF). Interventions: DRUG: Resmetirom; DRUG: Placebo. Primary outcome measures: Incidence of treatment-emergent adverse events (TEAEs) , From first dose through End of Study follow-up (28 days after last dose); Incidence of treatment-emergent serious adverse events (SAES) , From first dose through End of Study follow-up (28 days after last dose); Change from baseline in physical examination findings assessed by investigator physical examination , Baseline to Week 24; Change from baseline in body temperature , Baseline to Week 24; Change from baseline resting heart rate , Baseline to Week 24; Change from baseline in respiratory rate , Baseline to Week 24; Change from baseline in seated systolic blood pressure , Baseline to Week 24; Change from baseline in seated diastolic blood pressure , Baseline to Week 24; Change from baseline in PR interval on 12-lead ECG in milliseconds (ms) , Baseline to Week 24; Change from baseline in QRS interval on 12-lead ECG in milliseconds (ms) , Baseline to Week 24; Change from baseline in heart rate on 12-lead ECG in beats per minute (bpm) , Baseline to Week 24; Change from baseline in RR interval on 12-lead ECG in milliseconds (ms) , Baseline to Week 24; Change from baseline in QT interval on 12-lead ECG in milliseconds (ms) , Baseline to Week 24; Change from baseline in QT interval corrected using Bazett's formula (QTcB) in milliseconds (ms) , Baseline to Week 24; Change from baseline in QT interval corrected using Fridericia's formula (QTcF) in milliseconds (ms) , Baseline to Week 24; Number of participants with clinically significant abnormalities in hematology laboratory parameters , Baseline to Week 24; Number of participants with clinically significant abnormalities in blood chemistry laboratory parameters , Baseline to Week 24; Number of participants with clinically significant abnormalities in urinalysis parameters , Baseline to Week 24; Percent change from baseline in liver fat content measured by MRI-Proton Density Fat Fraction (MRI-PDFF) , Baseline to Week 24. Brief summary: This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). Participants are randomized 2:1 to resmetirom or placebo for 24 weeks.