Fixed BMI criteria in GLP-1 RA trials drastically reduce Asian population eligibility compared to Non-Asians
Background
Globally, metabolic diseases are on the rise, with obesity being a primary driver. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are effective treatments, yet clinical trials often underrepresent Asian populations. This is critical because Asian individuals frequently develop metabolic complications at lower Body Mass Index (BMI) values than Non-Asian populations, leading to a potential mismatch between trial eligibility and real-world disease burden in these groups.
Study Design
This cross-sectional study analyzed eligibility criteria from 352 GLP-1 RA trials registered on ClinicalTrials.gov between 2017 and 2020. Researchers then estimated the proportion of populations meeting these criteria using nationally representative health survey data. The analysis included 23,251 adults from the National Health and Nutrition Examination Survey (NHANES, US) and Korean NHANES (2021-2023), comprising 5,984 Non-Asian US, 353 Asian US, and 16,914 Korean individuals. The primary endpoint was the proportion of each population group meeting specified BMI eligibility criteria.
Results
BMI criteria, present in 233 (66.2%) of the analyzed trials, showed the most significant eligibility disparities. The mean BMI was substantially higher in Non-Asian US adults (29.8 kg/m2) compared to Asian US (24.9 kg/m2) and Korean (24.2 kg/m2) populations. For trials requiring a BMI ≥ 30 kg/m2, estimated eligibility was starkly different: > Eligibility was 41.5% for Non-Asian US adults, but only 13.5% for Asian US and 7.2% for Korean adults. In contrast, criteria for HbA1c, eGFR, and liver function showed minimal between-population differences, with over 93% of all groups meeting typical thresholds. These findings highlight a substantial bias in trial access.
Key Findings
- Fixed BMI criteria were present in 66.2% of GLP-1 RA trials analyzed.
- Mean BMI was 29.8 kg/m2 for Non-Asian US vs. 24.9 kg/m2 for Asian US and 24.2 kg/m2 for Korean adults.
- For BMI ≥ 30 kg/m2 trials, Non-Asian US eligibility was 41.5%.
- Asian US eligibility dropped to 13.5% for BMI ≥ 30 kg/m2 trials.
- Korean eligibility was lowest at 7.2% for BMI ≥ 30 kg/m2 trials.
Why It Matters
This research underscores a critical need for ethnicity-sensitive BMI thresholds in future GLP-1 RA trial designs. Current fixed BMI criteria disproportionately exclude Asian populations, potentially limiting their access to novel therapies and compromising the generalizability of trial data. For clinicians and researchers, this means that efficacy and safety data from current trials may not fully reflect the diverse patient populations who could benefit from GLP-1 RAs. Adopting more nuanced eligibility criteria could lead to more inclusive trials, better understanding of GLP-1 RA effects across different ethnic groups, and ultimately, more equitable access to treatment.
glp-1-ra
clinical-trials
bmi
asian-health
health-disparities
metabolic-disease