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<p>Resmetirom (Rezdiffra<sup>®</sup>), a selective thyroid hormone receptor (THR)-β agonist, represents a promising treatment option for patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH). It is the first FDA-approved treatment for MASH/NASH, granted under accelerated approval for use in conjunction with diet and exercise in adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). In the pivotal phase 3 MAESTRO-NASH trial, once-daily oral resmetirom was superior to placebo in achieving the histologic primary endpoints of resolution of NASH with no worsening of fibrosis, and fibrosis improvement by ≥ 1&#xa0;stage with no worsening of disease severity as measured by NAS. Treatment with resmetirom was also associated with statistically significant and clinically meaningful improvements in health-related quality of life (HRQoL). Resmetirom was generally well tolerated. The most common adverse events were gastrointestinal in nature, and most were of mild to moderate severity.</p>

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Resmetirom in metabolic dysfunction-associated steatohepatitis: a profile of its use

  • 期刊论文

  • 发表日期：

    2025年8月6日

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  • Hannah A. Blair

摘要

Resmetirom (Rezdiffra®), a selective thyroid hormone receptor (THR)-β agonist, represents a promising treatment option for patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH). It is the first FDA-approved treatment for MASH/NASH, granted under accelerated approval for use in conjunction with diet and exercise in adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). In the pivotal phase 3 MAESTRO-NASH trial, once-daily oral resmetirom was superior to placebo in achieving the histologic primary endpoints of resolution of NASH with no worsening of fibrosis, and fibrosis improvement by ≥ 1 stage with no worsening of disease severity as measured by NAS. Treatment with resmetirom was also associated with statistically significant and clinically meaningful improvements in health-related quality of life (HRQoL). Resmetirom was generally well tolerated. The most common adverse events were gastrointestinal in nature, and most were of mild to moderate severity.