Lexaria Bioscience Corp. has engaged a contract research organization to execute Human Pilot Study #7, which will evaluate two oral DehydraTECH-semaglutide compositions against commercially available Wegovy tablets. The study represents a significant step in testing enhanced formulations of GLP-1 medications, which are widely used for weight management and type 2 diabetes treatment.
Contracts with the CRO have been signed, and submissions are being prepared to obtain required ethics approval from an independent review board. The study design is virtually complete and is expected to be a five-week parallel group design investigating three separate arms to assess safety, tolerability, and pharmacokinetic properties. The research will compare salcaprozate sodium-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy tablets under fasted pre-dose conditions.
Lexaria hopes to preserve the superior safety and tolerability profiles evidenced in previous GLP-1 studies, such as GLP-1-H25-4, combined with pharmacokinetic performance that matches or exceeds that of commercial oral tablet brands Rybelsus and Wegovy. If successful, the study results will add to an already impressive data set aimed at generating interest from pharmaceutical partners seeking commercial relationships encompassing Lexaria's proprietary DehydraTECH technology.
This study explores several new DehydraTECH enhancements not previously evaluated. First, an oral tablet DHT-sema composition is being used by Lexaria for the first time, as opposed to the capsule compositions included in all previous DHT glucagon-like peptide-1 studies. Novo Nordisk's Rybelsus and Wegovy oral semaglutide medications both use specially formulated tablets designed to temporarily adhere to the stomach lining and disintegrate and dissolve releasing agents in a focal manner that aids in optimizing absorption of semaglutide into the human body. For the first time ever, Lexaria has attempted to mimic certain properties of this Rybelsus/Wegovy tablet delivery modality into its DHT-sema tablets.
Second, both the Lexaria DHT-sema tablet and capsule test articles will be formulated with SNAC, which will be the first time these formulations are evaluated over a multi-dose, multi-week time period in humans. The five-week duration of the study is expected to be long enough to reach steady-state, when drug concentrations in the body reach a constant concentration. Earlier DHT-sema human pilot studies that Lexaria conducted in 2024 and 2025 that also used SNAC were limited by single-dose study designs and were therefore of much shorter duration. Novo Nordisk's branded Rybelsus and Wegovy semaglutide-based products are both formulated with SNAC.
Lexaria will update stakeholders once ethics board approval for the study has been achieved, at which time patient recruitment can begin. The study is fully funded from existing corporate resources. DehydraTECH is Lexaria's patented drug delivery formulation and processing platform technology which improves how various drugs enter the bloodstream through oral delivery. The technology has demonstrated the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood-brain barrier. For more information about the company's technology platform, visit https://www.lexariabioscience.com.
The implications of this research are substantial for patients, healthcare providers, and the pharmaceutical industry. If Lexaria's enhanced formulations demonstrate improved pharmacokinetics while maintaining safety profiles, they could offer more effective treatment options for conditions requiring GLP-1 medications. The study's focus on tablet formulations that mimic commercial products suggests potential for easier integration into existing treatment protocols. Additionally, the multi-week evaluation period provides more clinically relevant data than previous single-dose studies, potentially accelerating the path toward commercialization partnerships and eventual regulatory approval.
