2837-LB: Pharmacokinetic and Safety Evaluation of AUL009, a Monthly Semaglutide-Loaded Microsphere Injectables Utilizing ExTenna Drug Delivery Technology in Healthy Male Subjects

Introduction and Objective: Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is widely used for the treatment of type 2 diabetes and obesity. However, once-weekly formulations may present adherent challenges and gastrointestinal adverse events related to peak plasma exposure. AUL009 is a semaglutide-loaded microsphere monthly injectables developed using ExTenna™ drug delivery technology to enable sustained drug release and reduce peak-related effects. This study evaluated the pharmacokinetics and safety of AUL009 in healthy male subjects. Methods: In this randomized study, twelve healthy male subjects received a single subcutaneous injection of either AUL009 (4 mg semaglutide) or once-weekly semaglutide (Wegovy® 1 mg). Plasma concentrations were measured for 56 days in the AUL009 group and 28 days in the reference group. Pharmacokinetic parameters were estimated using non-compartmental analysis (Phoenix® WinNonlin® v8.4). Results: Mean age and BMI were 43.1 ± 14.1 years and 23.6 ± 3.3 kg/m² in the AUL009 group and 51.7 ± 12.4 years and 24.5 ± 3.0 kg/m² in the reference group. AUL009 showed a lower Cmax (36.75 vs. 92.44 ng/mL) and a longer t½ (7.94 ± 3.01 vs. 6.16 ± 0.48 days). Mild to moderate adverse events occurred in the reference group (10 events in 4 subjects), while none were observed with AUL009. Conclusion: AUL009 demonstrated delayed absorption, prolonged systemic exposure, and reduced peak concentration compared with once-weekly semaglutide, supporting its potential as a monthly semaglutide-loaded microsphere injectables with a favorable safety profile. Disclosure S. Kim: Employee; Current; AULBIO. C. Kim: Board Member; Current; AULBIO. T. An: Board Member; Current; AULBIO. A. Kim: Board Member; Current; AULBIO. J. Park: Employee; Current; AULBIO.