Recruitment of Minority Patients in Metabolic Dysfunction-Associated Steatotic Liver Disease Clinical Trials.

Abstract

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the second leading indication for liver transplant in the United States, but the prevalence is unevenly distributed across ethnic groups with 22.3% of Hispanic patients affected. This study aimed to assess racial and ethnic diversity among MASLD clinical trials. We performed a meta-analysis of 91 randomized controlled trials (RCTs) of MASLD therapies in the US and Canada, and multinational RCTS involving the US from 2005 to 2024. 78 studies (85.7%) reported racial data and only 56 (61.5%) included ethnicity data. Meta-analysis revealed a pooled prevalence of 78.8% (95% CI 72.9 - 84.6, I² = 97.0%) in White patients, 6.2% (95% CI 4.1 - 8.3, I² = 94.1%) in Asian patients, 2.5% (95% CI 1.6 - 3.5, I² = 70.2%) in Black patients, and 31.7% (95% CI 26.8-36.6, I² = 96.2%) in Hispanic patients. This prevalence was higher than the reported national Hispanic prevalence, and Hispanic enrollment also increased over time from 20.3% (2009 - 2014), 30.8% (2015-2019), to 40.0% (2020-2024). Our results show that compared to previous efforts, clinical trials are increasingly including Hispanic patients, yet they still need to increase inclusion of ethnicity data. Since MASLD disproportionately affects Hispanic patients, it is imperative that clinical trials make a targeted effort to diversify patient recruitment.