Objectives/Goals: The study aims to systematically characterize the frequency and distribution of serious and non-serious adverse events by intervention arm and organ system in clinical trials of GLP-1 drugs using the publicly available Aggregate Content of ClinicalTrials.gov (AACT) database. Methods/Study Population: The ClinicalTrials.gov database was searched on 9/11/25 for interventional studies with GLP-1 as treatment (n= 1545). The search was filtered to terminated and completed studies with results (n= 349). Study information, including adverse event reports, was downloaded from Clinical Trials Transformation Initiative (CTTI) AACT database. Data were filtered to phase 2-4 studies (n= 247), followed by drug intervention studies (n= 240). Of these, 167 studies involved the use of a GLP1-1 drug. Adverse events were summarized using study size-weighted mean proportions with chi-squared and Fisher’s exact tests for significance, stratified by intervention arm, seriousness, and organ system. Results/Anticipated Results: Across 167 GLP-1 trials, the weighted proportion of participants experiencing non-serious adverse events was higher in drug arms than in placebo (4.3% vs. 3.3%, p < 0.001). Serious events were uncommon but slightly higher in drug arms (0.1% vs. 0.1%, p = 0.01). The most frequently affected organ systems for non-serious events were gastrointestinal, metabolism/nutrition, and infections/infestations. Among serious events, cardiac disorders were most frequent, occurring less often in the drug arm (0.2% vs. 0.3%, p < 0.001). Discussion/Significance of Impact: Elevated adverse event rates in GLP-1 trials were primarily due to non-serious events across multiple organ systems. Leveraging the AACT database demonstrates the feasibility of harmonizing trial-level adverse event information to assess safety patterns across diverse trial populations.
Steimel et al. (Wed,) studied this question.