Lexaria Bioscience Corp. has announced the engagement of 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 oral drug delivery research for glucagon-like peptide-1 medications, which are widely used in diabetes and weight management treatments.
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 study will compare salcaprozate sodium-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy tablets under fasted pre-dose conditions.
This study explores several new DehydraTECH enhancements not previously evaluated. For the first time, Lexaria is using an oral tablet DHT-sema composition, as opposed to the capsule compositions included in all previous DHT GLP-1 studies. The company has attempted to mimic certain properties of the Rybelsus and Wegovy tablet delivery modality into its DHT-sema tablets. 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.
If successful, the study results will be additive to an already impressive data set aimed at generating interest from pharmaceutical partners seeking to enter into commercial relationships encompassing Lexaria's proprietary DehydraTECH technology. Lexaria hopes to preserve the superior safety and tolerability profiles as evidenced in previous Lexaria GLP-1 studies such as GLP-1-H25-4, combined with pharmacokinetic performance that matches or exceeds that of the commercial oral tablet brands Rybelsus and Wegovy.
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's technology, visit https://www.lexariabioscience.com. The original release can be viewed at https://www.newmediawire.com.
