Clinical Profile of Nonalcoholic Fatty Liver Disease in Adults with Type 2 Diabetes Mellitus.

Challenge

Adults with T2D represent a large and clinically important NAFLD subgroup, but the real-world clinical profile—including disease severity, comorbidities, and treatment patterns—of adults with NAFLD and concurrent T2D had not been systematically characterized at scale.

Solution

The TARGET-NASH cohort was used to compare clinical characteristics, disease severity distribution, and medication use between NAFLD patients with and without T2D, characterizing the T2D-NAFLD co-morbidity profile in a large real-world US population.

Impact

Characterizing that NAFLD patients with T2D have higher fibrosis burden and more advanced disease at enrollment provides the evidence base for T2D-based enrichment in NAFLD trials and supports the regulatory rationale for subgroup analyses in metabolic drug development for MASH.