Clinical Profile of Adults with Nonalcoholic Steatohepatitis (NASH) with and without Type 2 Diabetes Mellitus (T2DM).

Challenge

T2D is highly prevalent in NASH but the specific clinical profile differences between NASH patients with and without T2D—including disease severity, comorbidities, and laboratory parameters—had not been characterized in a large real-world US population, limiting the precision of T2D-based trial enrichment.

Solution

The TARGET-NASH cohort was used to compare clinical characteristics, disease severity markers, and metabolic profiles between adults with NASH and T2D versus NASH without T2D, providing a detailed real-world characterization of this high-risk subgroup.

Impact

Characterizing that T2D-associated NASH patients have significantly higher fibrosis burden and more metabolic comorbidities at enrollment provides the evidence base for designing T2D-enriched NASH trials and supports the regulatory argument for T2D subgroup analyses in metabolic MASH programs.