S2395 A Systematic Review of Gender, Racial and Ethnic Representation in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Clinical Trials in the United States

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD) affects 25-30% of US adults and there are known racial and ethnic differences in disease prevalence and rates of progression. There are many ongoing trials of potential therapies, but minimal data exists to characterize participant demographics. Here we characterize the gender, ethnic and racial breakdown of US clinical trials to understand disparities in minority representation. Methods: We conducted a systematic review of all completed trials with results on Clinicaltrials.gov from inception to March 2024. Included studies were limited to MASLD and MASLD-Cirrhosis in adults. Studies were excluded if clinical sites were outside of the US. Racial and ethnic composition of MASLD was calculated using prevalence rates and the 2020 US Census. Data pertaining to age, gender, race, and ethnicity were abstracted. Results: Two hundred eleven trials were retrieved and 51 trials with 4,225 participants were included. The mean age was 52.14 (SD 10.66) and woman (n = 2,288; 54.2%) participants exceeded men (n = 1937; 45.8%). Ethnicity data was available in 41/51 (81%) of studies, with fewer Hispanic vs Non-Hispanic enrollees (n = 3,492; 37.1% vs 62.9%). Enrollment breakdown by race was reported in 50/51 studies with the largest representation among White enrollees and the lowest among Native Hawaiian/Pacific Islanders [(n = 4,124; White = 3,561 (86.3%), Black = 203 (4.92%), Asian = 139 (3.4%), Native American = 23 (0.6%), Native Hawaiian/Pacific Islander = 14 (0.34%), other races = 64 (1.6%)]. Compared to national prevalence estimates, Hispanic (37.1% vs 23.7%) and White (86.3% vs 59.7%) enrollees were over-represented, while Black (4.92% vs 9.2%) and Asian (3.4% vs 5.9%) enrollees were underrepresented. Conclusion: This review of demographics in MASLD trials suggests several key disparities. Importantly, we noted low absolute and relative Black and Asian enrollment. Diversity of trial inclusion is key to understanding biological differences in outcomes, and the limited trial data in these minorities is striking. Research identifying barriers to inclusion such as language, medical mistrust or socioeconomic factors should be studied to ensure future clinical trials recruit patients that accurately reflect the national racial and ethnic distribution of MASLD. Additionally, significant heterogeneity was noted in ethnic and racial reporting, which is critical to address especially given the increase in multi-ethnic/multi-racial backgrounds in the US.