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Lexaria Awards CRO Contract for 12-Week DehydraTECH GLP-1 Chronic Human Study
Weight Loss and Blood Sugar Reduction are Major Efficacy Objectives KELOWNA, BC / ACCESSWIRE / June 18, 2024 / Lexaria Bioscience Corp.
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"Weight Loss and Blood Sugar Reduction are Major Efficacy Objectives KELOWNA, BC / ACCESSWIRE / June 18, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX,)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms announces it has now hired a contract research organization (\"CRO\") to oversee execution of the Company's 12-week chronic study GLP-1-H24-4, (the \"Study\") which will evaluate various DehydraTECH-GLP-1 (glucagon-like peptide) formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.Study preparations with the CRO have commenced pursuant to an initial start-up agreement under which a number of activities will occur such as full clinical protocol design and writing in consultation with medical experts, regulatory authority submissions, and data management planning.\"This Study will be the most comprehensive and impactful GLP-1 investigation that Lexaria has ever undertaken,\" said John Docherty, President of Lexaria Bioscience Corp. \"The greatly expanded scope compared to our previous studies will allow us to investigate DehydraTECH-GLP-1 safety and efficacy over an extended treatment duration to significantly broaden our knowledge of DehydraTECH's ability to potentially improve the effectiveness and tolerability of this world-leading class of drugs.\"The Study will be conducted using a number of clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. Upon completion, the Study is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration (\"FDA\").About The StudyThe currently-planned design of the Study has been expanded to include five active treatment arms, each with 16 diabetic patients (80 patients in total), with each patient dosed orally daily, subject to change once the final protocol is complete.Rybelsus® as positive control;DehydraTECH-cannabidiol (\"CBD\");DehydraTECH-semaglutide;DehydraTECH-CBD combined with DehydraTECH-semaglutide; and,DehydraTECH-tirzepatide.An important component of this Study will be the fact that Lexaria intends to test DehydraTECH-GLP-1 formulations prepared using pure GLP-1 drug substances such as semaglutide and the dual action GLP-1 / GIP (glucose-dependent insulinotrop...