Lexaria Bioscience Corp. has announced it received ethics board approval to begin its Phase 1b, 12-week chronic study GLP-1-H24-4, designed to evaluate its DehydraTECH technology in enhancing the oral delivery of GLP-1 receptor agonists for diabetes and weight loss. The company also stated that the clinical test article manufacturing for all planned study arms has been completed.
The study will investigate five arms, including DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, a combination of both, Rybelsus® tablets (semaglutide), and an optional arm with DehydraTECH-tirzepatide capsules. The trial is planned to involve 20 overweight, obese, pre- or type 2 diabetic patients for each of study arms 1-4.
Study Design and Objectives
The trial is structured as a registrational Phase 1b study under Australian clinical regulatory authority regulations and is being conducted across seven clinical investigational sites in Australia. Lexaria anticipates that the study will be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration (FDA).
Arms 2 and 3 of the study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4, which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk’s proprietary salcoprozate sodium (“SNAC”) technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.
Lexaria aims to determine if DehydraTECH processing of semaglutide can outperform Rybelsus® in blood sugar control and weight loss, and whether it can reduce side effects associated with GLP-1RA therapy. The study will also assess the safety and efficacy of DehydraTECH-CBD alone or in combination with DehydraTECH-GLP-1 drugs.
DehydraTECH Technology
DehydraTECH is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Lexaria believes DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds.
Prior Research
In a previous animal study, DehydraTECH-CBD demonstrated a 7% weight loss and a 19.9% reduction in blood glucose levels (p<0.05) without GLP-1 drugs. Lexaria's first GLP-1 study in humans showed that DehydraTECH processing of Rybelsus®-branded semaglutide improved blood sugar control and increased semaglutide levels in the blood after a single dose, compared to Rybelsus® alone.
