Resmetirom (THR-beta, Non-incretin Benchmark)
MARKETED
CONTEXT BENCHMARK (NON-incretin). Resmetirom (Rezdiffra, Madrigal) is the FIRST FDA-approved MASH drug, approved on the MAESTRO-NASH histological co-primaries....
Harrison SA, Bedossa P et al. MAESTRO-NASH. N Engl J Med 2024;390:497-509.
Source
Full findingCONTEXT BENCHMARK (NON-incretin). Resmetirom (Rezdiffra, Madrigal) is the FIRST FDA-approved MASH drug, approved on the MAESTRO-NASH histological co-primaries. Included as the regulatory/efficacy benchmark against which incretin MASH efficacy is read, NOT as a class finding. Like ESSENCE it gained accelerated approval on histological SURROGATES; hard-outcome confirmation has not yet read out. Cross-trial comparison with ESSENCE is informal only (different populations, no head-to-head).
PopulationMAESTRO-NASH (NCT03900429), phase 3, 3 arms (80/100 mg/placebo), n=966 primary-analysis. Biopsy NASH fibrosis F1B/F2/F3; F4/CIRRHOSIS EXCLUDED. 52 wk.
Fundingindustry - Madrigal Pharmaceuticals
Scope limitssurrogate/exploratory endpoint
Comparatorsplacebo; resmetirom 80 mg; resmetirom 100 mg