A new analysis of clinical trials for metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease, found that the people enrolled in these studies do not fully reflect the diversity of the patients who get the disease. The analysis looked at 91 randomized controlled trials conducted in the United States and Canada and found that while most trials reported race, fewer reported ethnicity. Specifically, 78 out of 91 trials (85.7%) reported racial data, but only 56 trials (61.5%) included ethnicity data. Among the trials that did report, White patients made up the largest share at 78.8%, followed by Hispanic patients at 31.7%, Asian patients at 6.2%, and Black patients at just 2.5%. The numbers add up to more than 100% because patients can identify with multiple categories. The analysis also found that Hispanic enrollment has increased over time, from 20.3% in 2009-2014 to 30.8% in 2015-2019 and 40.0% in 2020-2024. This is important because MASLD disproportionately affects Hispanic people, yet they are still underrepresented in some ways. The study is a meta-analysis, meaning it combines results from many trials, so it cannot tell us about individual patient outcomes. The findings suggest that researchers need to do a better job of reporting ethnicity and enrolling diverse participants so that new treatments work for everyone. If you have questions about MASLD and your risk, talk to your doctor.
Clinical trials for MASLD show limited racial and ethnic diversity despite increasing Hispanic enrollmentClinical trials for fatty liver disease lack diversity
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This meta-analysis synthesized data from 91 randomized controlled trials to evaluate the diversity of participants in MASLD clinical trials conducted in the United States and Canada. The analysis focused on the reporting of racial and ethnic data to determine if clinical trials adequately represent the diverse populations affected by the disease.
Key findings indicate that while 85.7% of studies reported racial data, only 61.5% included ethnicity data. The pooled prevalence of White patients was 78.8% (95% CI 72.9 - 84.6). Other groups showed lower representation: Asian patients were 6.2% (95% CI 4.1 - 8.3), Black patients were 2.5% (95% CI 1.6 - 3.5), and Hispanic patients were 31.7% (95% CI 26.8 - 36.6). Notably, Hispanic enrollment showed a steady increase over time, rising from 20.3% (2009-2014) to 30.8% (2015-2019) and reaching 40.0% (2020-2024).
Clinical relevance is centered on the need for improved inclusion of ethnicity data. While Hispanic participation is increasing, the current data suggests that clinical trials may still lack the diversity needed to address the disproportionate impact of MASLD on Hispanic patients. The results highlight a gap in reporting and representation that may affect the generalizability of findings to diverse patient populations.
How this fits prior evidence
This meta-analysis addresses a gap in the existing evidence regarding the demographic representation of patients in MASLD clinical trials. While prior coverage has established the efficacy of interventions like HIIT, MICT, and telmisartan, and the utility of AI for diagnosis, this study specifically addresses the diversity of the populations being treated. It highlights that while Hispanic enrollment is increasing from 20.3% to 40.0%, the majority of participants remain White (78.8%).
Common questions
What is MASLD?
MASLD stands for metabolic dysfunction-associated steatotic liver disease. It is a condition where fat builds up in the liver, often linked to obesity, diabetes, and high cholesterol. It was previously called non-alcoholic fatty liver disease (NAFLD).
Why is diversity in clinical trials important?
Diversity in clinical trials helps ensure that new treatments work for all people who might use them. Different racial and ethnic groups can respond differently to medications. If trials do not include enough people from certain groups, the results may not apply to them.
How many patients in the trials were Black?
In the trials that reported race, the pooled prevalence of Black patients was 2.5%. This is much lower than the proportion of Black people in the general population, suggesting that Black patients are underrepresented in MASLD research.
More on Metabolic Dysfunction-Associated Steatotic Liver Disease
View Original Abstract ↓
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