Lexaria Provides Positive Interim Results on Partial 8-week Data From Phase 1b, GLP-1-H24-4 Study

Core Insights - Lexaria Bioscience Corp. has reported positive interim results from its phase 1b study GLP-1-H24-4, focusing on its DehydraTECH drug delivery platform compared to Rybelsus® [1][2] Group 1: Study Results - After 8 weeks of treatment, DehydraTECH-GLP-1 arms showed a significant reduction in adverse events (AEs) compared to Rybelsus®, with 79.2% of DHT-semaglutide patients experiencing at least one AE versus 100% for Rybelsus® [2][4] - DehydraTECH-semaglutide demonstrated a 36.5% reduction in overall AEs and a 43.5% reduction in gastrointestinal (GI) AEs compared to Rybelsus® [3][4] - The total number of AEs for DHT-semaglutide was 61, while Rybelsus® had 96 AEs, indicating a 63.5% reduction in AEs for DHT-semaglutide relative to the control [2][4] Group 2: Efficacy Metrics - The study is assessing changes in glycated hemoglobin (HbA1c) and body weight as primary efficacy endpoints [7] - After 8 weeks, DHT-semaglutide resulted in an average weight loss of -1.14 kg (-1.23%), while DHT-tirzepatide showed a weight loss of -4.14 kg (-4.23%) [9][10] - HbA1c levels decreased by -0.14% for DHT-semaglutide, with no statistically significant difference compared to Rybelsus® at this interim stage (p=0.069) [11] Group 3: Comparative Analysis - In comparison to Novo Nordisk's® STEP studies, where 88.1% of patients experienced AEs, only 79.2% of patients in the DHT-semaglutide arm experienced AEs, suggesting a potential for improved patient adherence to treatment protocols [5] - The DHT-tirzepatide arm showed a lower proportion of GI-related AEs (22%) compared to injected tirzepatide studies, which reported 40% to 50% GI-related AEs [6] Group 4: Future Outlook - Additional data from the study will be processed and may be released in the coming weeks, with final results expected near the end of 2025 [12][13] - The study is approaching the "last patient last visit" milestone and remains on schedule [13]