Core Insights - Lexaria Bioscience Corp. has released additional data from its Phase 1b clinical study GLP-1-H24-4, which focuses on the efficacy of its DehydraTECH™ technology compared to Rybelsus® [1][2] Secondary Efficacy Parameters - At week 16, the DHT arms showed no statistically significant differences compared to the Rybelsus® control in mean fasting glucose, cholesterol, and LDL cholesterol [3] Body Composition - The DHT-semaglutide arm showed a modest reduction in fat mass of -1.08 kg and total mass of -1.40 kg, while the Rybelsus® control arm achieved greater reductions of -3.55 kg in fat mass and -5.36 kg in total mass, with a higher reduction in lean mass of -1.72 kg [4] Blood Pressure Analyses - The DHT-CBD arm achieved significant reductions in blood pressure, with a mean change of -4.6 mmHg in systolic and -4.0 mmHg in diastolic blood pressure at week 4 [5][6] Pharmacokinetic Exploratory Analyses - Plasma CBD concentrations were quantifiable through week 16 in the DHT-CBD arms, while semaglutide concentrations were not quantifiable due to assay issues, although preliminary tests indicated measurable levels [8] Health Survey Results - Participants in the DHT-semaglutide arm reported mean improvements of over 5 points in physical components and over 3 points in mental components of the SF-36 health survey, compared to modest improvements in the Rybelsus® control arm [9][10] Overall Conclusions and Next Steps - The study met its primary endpoint, demonstrating good safety and tolerability of all DHT test articles, with positive findings across various parameters compared to Rybelsus® [11] Future Plans - Lexaria plans to pursue further clinical testing with a DHT + SNAC + semaglutide composition and is in discussions with a pharmaceutical company regarding the dataset from the study [15][17][18]
Lexaria Releases Additional Results from its Successful Phase 1b Study GLP-1-H24-4