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Return to Activity: Assessing the Data for Novel Nonalcoholic Steatohepatitis Therapies

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Assessing the Data for Novel Nonalcoholic Steatohepatitis Therapies

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
What is the mechanism of action of obeticholic acid?

GLP-1 inhibitor

FXR agonist

THRβ selective agonist

PPAR agonist
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%

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