Summary

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• Resmetirom (Rezdiffra) is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
• The information was derived from two randomized controlled trials.
• In a Phase 3 trial, resmetirom showed superior outcomes compared to placebo in NASH resolution and fibrosis improvement, achieving significant reductions in LDL-C levels as well.
• Safety data revealed that while diarrhea and nausea were more common among those taking resmetirom, serious adverse events occurred at similar rates across all groups (~11-13%).
• Another Phase 3 trial demonstrated high but comparable incidence rates of treatment-emergent adverse events between resmetirom and placebo groups; however, significant improvements were noted in secondary endpoints like hepatic fat reduction.
• Population types included adults diagnosed or presumed to have NASH; specific subgroup details such as age ranges or comorbidities were not provided.