resmetirom
resmetirom: sourced relationships with 1 company · 7 clinical trials tracked.
resmetirom evidence translation
What we can confirm
7 tracked trials
What it means
What to watch
Prepared research question
How could resmetirom → MDGL affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| MADRIGAL PHARMACEUTICALS, INC. (MDGL) | Phase 4 |
| MADRIGAL PHARMACEUTICALS, INC. (MDGL) NASH; MASH - Metabolic Dysfunction-Associated Steatohepatiti… | Phase 4 |
Clinical Trial Registry Records (7)
A Phase 4, Open-label, Multi-group Study of Rezdiffra® in Combination With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and Moderate to Advanced (F2-F3) Fibrosis, Administered According to Their Approved Labeling
Primary endpoint: Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
A Phase 1b, Multi-Center, Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Hepatic Pharmacodynamics of Resmetirom in Patients With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Heart Failure With Preserved Ejection Fraction (HFpEF)
Primary endpoint: Incidence of treatment-emergent adverse events (TEAEs)
A Phase 2a, Multicenter, Open-label, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Resmetirom in Pediatric Subjects Ages 6-17 Years With MASH With Fibrosis Stage F1-F3
Primary endpoint: Safety and tolerability of multiple ascending doses of resmetirom
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies
Primary endpoint: Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants
Primary endpoint: Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH-OUTCOMES)
Primary endpoint: Incidence Of adjudicated Composite Clinical Outcome event
A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
Primary endpoint: The effect of once daily, oral administration of resmetirom on the incidence of adverse events.
Frequently asked questions
Which companies have sourced relationships with resmetirom?
resmetirom has dated SEC/FDA relationship records for MADRIGAL PHARMACEUTICALS, INC..
How many clinical trials involve resmetirom?
BioSniper tracks 7 clinical trials involving resmetirom.