Fixed BMI criteria for GLP-1 RA trials significantly reduce Asian eligibility compared to Non-Asian populations

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are crucial for managing type 2 diabetes and obesity, with demonstrated cardiovascular benefits. However, Asian populations exhibit distinct metabolic profiles, developing metabolic syndrome and higher body fat percentages at lower Body Mass Index (BMI) values than Caucasians. Current clinical trial eligibility criteria for GLP-1 RAs often use uniform BMI thresholds across ethnic groups, potentially leading to underrepresentation and limiting the generalizability of findings for diverse populations.

This cross-sectional analysis characterized the estimated trial-eligible proportions for GLP-1 RA clinical trials across different ethnic populations. Researchers analyzed existing trial eligibility criteria, specifically focusing on fixed BMI thresholds (e.g., BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 for overweight). The study compared eligibility rates for Non-Asian US, Asian US, and Korean adults, contrasting BMI-based criteria with other common eligibility factors such as HbA1c, eGFR, and liver function to identify sources of disparity.

The study revealed stark disparities in trial eligibility driven by fixed BMI criteria. For trials requiring BMI ≥ 30 kg/m2, eligibility was 41.5% for Non-Asian US adults, but significantly lower at 13.5% for Asian US adults and just 7.2% for Korean adults.

This indicates that fixed BMI thresholds lead to a 3- to 6-fold reduction in eligibility for Asian populations compared to Non-Asian populations. In contrast, when considering other common eligibility criteria such as HbA1c, eGFR, and liver function, the study found minimal between-population differences, with over 93% of individuals across all groups meeting typical thresholds. This strongly suggests that BMI criteria are the primary driver of ethnic underrepresentation in GLP-1 RA clinical trials, failing to account for the distinct metabolic profiles of Asian individuals who develop metabolic disease at lower BMI values.