Clinical Trial: Phase 3 Trial of Resmetirom Versus Placebo in Metabolic Dysfunction-Associated Steatohepatitis-Reanalysis of Fibrosis Stage 2-3 Subset.
Maria Mironova, Krishna Padmanabhan, David Schneider et al.
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In 30 seconds
This phase 3 randomized controlled trial analyzed the efficacy of resmetirom in patients with metabolic dysfunction-associated steatohepatitis (MASH) and F2 or F3 fibrosis. Among 917 patients, MASH resolution was achieved in 29.9% of those receiving 100 mg of resmetirom compared to 9.5% in the placebo group (p < 0.0001).
Key findings
- MASH resolution was achieved in 29.9% of the 100-mg resmetirom group versus 9.5% in placebo (p < 0.0001).
- Fibrosis improvement occurred in 28.9% of the 100-mg resmetirom group compared to 17.3% in placebo (p < 0.01).
- Low-density lipoprotein cholesterol decreased by 13.7% in the 100-mg resmetirom group, while it increased by 2.3% in placebo (p < 0.0001).
Why it matters
The findings support the use of resmetirom in treating MASH in patients with significant fibrosis, highlighting its potential to improve liver histology and metabolic parameters.