Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis.
Stephen A HarrisonVlad RatziuQuentin Mark AnsteeMazen NoureddinArun J SanyalJörn Markus SchattenbergPierre BedossaMustafa R BashirDavid SchneiderRebecca TaubMeena BansalKris V KowdleyZobair M YounossiRohit LoombaPublished in: Alimentary pharmacology & therapeutics (2023)
The MAESTRO clinical programme was designed in conjunction with regulatory authorities to support approval of resmetirom for treatment of NASH. The surrogate endpoints, based on week 52 liver biopsy, serum biomarkers and imaging, are confirmed by long-term clinical liver-related outcomes in MAESTRO-NASH (month 54) and MAESTRO-NASH-OUTCOMES (time to event).