Lexaria Bioscience Initiates New Human Clinical Study for Enhanced GLP-1 Drug Delivery

Lexaria Bioscience Corp. has engaged a contract research organization to execute and report on its Human Pilot Study #7 (GLP-1-H26-7), which will evaluate two oral DehydraTECH-semaglutide compositions against commercially available Wegovy tablets. 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 5-week parallel group design investigating three separate arms to assess safety, tolerability, and pharmacokinetic properties.

The study 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 Lexaria 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 be additive 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 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. For the first time, 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 5-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 its 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. For more information about the company and its technology, visit https://www.lexariabioscience.com. The original press release can be viewed at https://www.newmediawire.com.