resmetirom
resmetirom: developed by 1 company · 5 clinical trials tracked.
resmetirom evidence translation
What we can confirm
5 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
Development Pipeline (2)
| Company | Phase |
|---|---|
| MADRIGAL PHARMACEUTICALS, INC. (MDGL) Treatment of adults with noncirrhotic MASH with moderate to … | Approved |
| MADRIGAL PHARMACEUTICALS, INC. (MDGL) MASH - Metabolic Dysfunction-Associated Steatohepatitis; MAS… | Phase 3 |
Clinical Trials (5)
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
Who is developing resmetirom?
resmetirom is being developed by MADRIGAL PHARMACEUTICALS, INC..
How many clinical trials involve resmetirom?
BioSniper tracks 5 clinical trials involving resmetirom.