Understanding Metabolic Dysfunction-Associated Steatohepatitis: Differences in Clinical and Demographic Characteristics Across Racial and Ethnic Groups.

Challenge

Racial and ethnic disparities in MASH presentation, clinical characteristics, and outcomes were understudied in large prospective real-world cohorts, limiting the ability of sponsors and regulators to evaluate trial generalizability and address health equity requirements in MASH drug development.

Solution

The TARGET-NASH cohort was stratified by race and ethnicity to characterize differences in clinical presentation, disease severity, comorbidities, and treatment patterns across Non-Hispanic White, Hispanic, Black, and other patient groups enrolled at academic and community sites across the US.

Impact

Generating real-world evidence on demographic differences in MASH presentation and outcomes supports sponsor commitments to diverse trial enrollment, informs subgroup analysis planning in regulatory submissions, and demonstrates the breadth of TARGET-NASH's population coverage.