Characteristics of adult MASH patients and factors associated with MASH-relevant clinical endpoints in a real-world US cohort

Beyond understanding population-level disease progression, sponsors and investigators needed to identify which specific patient characteristics—demographic, clinical, geographic, and treatment-related—predict progression to clinically meaningful composite endpoints across MASH severity strata.

A companion to the disease progression poster, this analysis used Fine-Gray multivariable hazard models on the same TARGET-NASH population to identify predictors of MASH-relevant composite endpoints within each disease severity subgroup, providing actionable enrichment criteria.

Identifying that academic site care, high FIB-4, T2D, and CYP3A inhibitor use predict composite endpoints across disease severity strata provides sponsors with evidence-based criteria for stratifying enrollment in MASH outcome trials and designing risk-adaptive study designs.

Predictive enrichment factor identification for MASH outcome trial design, Clinical endpoint predictor profiling across MASH severity strata, Real-world evidence base for adaptive trial design and patient stratification in MASH