This white paper examines the challenges of recruiting patients with metabolic dysfunction-associated steatohepatitis (MASH) and compensated cirrhosis (F4 MASH) into clinical trials. Using de-identified data from the TriNetX database of 179 million U.S. adults, IQVIA estimates disease prevalence while accounting for significant underdiagnosis. It also evaluates how common eligibility criteria—including decompensated cirrhosis, other liver diseases, alcohol use disorder, and GLP-1 or SGLT2 therapy—reduce the eligible patient pool. The paper recommends earlier diagnosis, risk-based patient identification, improved provider awareness, and targeted recruitment strategies to strengthen enrollment, improve trial planning, and accelerate the development of new therapies for advanced MASH.

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