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Assessing the Data for Novel Nonalcoholic Steatohepatitis Therapies

  1. The FDA accepts 1 of 2 endpoints for phase 3 registration trials in NASH.
    What are the endpoints?
    Fibrosis improvement, with no worsening of NASH and relative fat reduction in the liver
    NASH resolution, with no worsening of fibrosis and reduction in liver enzymes
    Reduction in liver enzymes and relative fat reduction in the liver
    Fibrosis improvement with no worsening of NASH, and NASH resolution with no worsening of fibrosis
  2. What is the mechanism of action of obeticholic acid?
    GLP-1 inhibitor
    FXR agonist
    THRβ selective agonist​
    PPAR agonist
  3. In the MAESTRO-NASH trial, approximately what percentage of patients receiving any dose of resmetirom showed NASH resolution with ≥ 2-point reduction in NAS and no worsening fibrosis?
    1% to 10%
    11% to 20%
    21% to 30%
    31% to 40%