Lexaria Awards CRO Contract for 12-Week DehydraTECH Human Study

Lexaria Bioscience Corp., a pioneering entity in drug delivery platforms, has commenced a notable 12-week chronic study, named GLP-1-H24-4. The study is designed to explore various DehydraTECH-GLP-1 formulations and other treatments with primary efficacy objectives of weight loss and blood sugar reduction.

To oversee the execution of this study, Lexaria has engaged a contract research organization (CRO). Preparations are already underway, including the design of a comprehensive clinical protocol, consultation with medical experts, submissions to regulatory authorities, and data management planning.

John Docherty, President of Lexaria Bioscience Corp., emphasized the significance of this study, noting its expanded scope compared to previous studies. This extensive investigation aims to assess the safety and efficacy of DehydraTECH-GLP-1 over a prolonged treatment period, potentially enhancing the effectiveness and tolerability of this class of drugs.

The study will be conducted across multiple clinical sites in Australia, adhering to the country's clinical regulatory authority regulations. Upon completion, it is expected to gain recognition as a Phase 1b registrational study by the U.S. Food and Drug Administration (FDA).

The study design currently includes five active treatment arms, each comprising 16 diabetic patients, totaling 80 patients. These patients will be administered oral doses daily. The treatment arms consist of:
1. Rybelsus® as a positive control
2. DehydraTECH-cannabidiol (CBD)
3. DehydraTECH-semaglutide
4. DehydraTECH-CBD combined with DehydraTECH-semaglutide
5. DehydraTECH-tirzepatide

A crucial aspect of the study is Lexaria's plan to test DehydraTECH-GLP-1 formulations using pure GLP-1 drug substances like semaglutide and tirzepatide, without the need for commercially approved products such as Rybelsus® and Zepbound®. This approach allows the evaluation of DehydraTECH's effectiveness independently.

Lexaria recalls its 2022 diabetes study, DIAB-A22-1, which used a unique DehydraTECH-CBD formulation. This study demonstrated a 7% weight loss and a significant reduction in blood glucose levels by 19.9%±7% in a multi-week rodent study, without any GLP-1 drugs. Lexaria is keen to determine if adding DehydraTECH-CBD to a GLP-1 weight loss program could enhance weight loss or reduce side effects compared to GLP-1 alone.

In its first human GLP-1 study reported in January 2024, Lexaria found that DehydraTECH processing of Rybelsus®-branded semaglutide improved blood sugar control and achieved higher levels of semaglutide in the blood after a single dose, compared to Rybelsus® itself. The upcoming study aims to see if this improved pharmacokinetic performance could lead to better weight loss or blood sugar control after multi-week dosing.

Lexaria will continue to provide updates as the manufacturing of all clinical test articles, the Research Ethics Committee review, and the Australian Therapeutic Goods Administration notification progress. Once these milestones are met and the protocol development is finalized, the company will be able to estimate the dates for first patient dosing and study completion more accurately.

Lexaria Bioscience Corp. specializes in DehydraTECH™, a patented drug delivery formulation technology that enhances the absorption of active pharmaceutical ingredients (APIs) through oral delivery. Since 2016, Lexaria has been developing DehydraTECH with various beneficial molecules in oral and topical formats. DehydraTECH has consistently shown an ability to increase bio-absorption and effectively deliver certain drugs across the blood-brain barrier. Lexaria operates a licensed in-house research laboratory and maintains a robust intellectual property portfolio with numerous granted and pending patents worldwide.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!