Lexaria Bioscience Corp. provided this update on Human Pilot Study #7 (GLP-1-H26-7) that will evaluate 2 oral DehydraTECH-semaglutide (?DHT-sema?) compositions against Novo Nordisk?s commercially available Wegovy tablets (the ?Study?). Submissions have now been entered to formally request the required ethics approval from an independent review board.
Final laboratory tablet composition work and commercial-scale manufacturing for the DHT-sema test articles for the Study have been completed with third-party independent lab quality-control (?QC?) testing of such test articles currently underway. It is anticipated that receipt of ethics approval, completion of QC testing and packaging of the qualified test articles (the ?Pre-Dosing Tasks?) will occur by early June. The design of this Study is complete, subject to any modifications which may or may not be required by the ethics reviewers.
The Study is planned to be a 5-week parallel group design, investigating 3 separate arms to assess safety & tolerability and pharmacokinetic (?PK?) properties that will compare salcaprozate sodium (?SNAC?)-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy tablets. The Study will be conducted under fasted pre-dose conditions. Lexaria hopes to preserve the superior safety and tolerability profiles as evidenced in previous Lexaria GLP-1 studies such as Human Study #4 (GLP-1-H25-4), combined with PK performance that matches or exceeds that of the commercial oral tablet as also evidenced in previous Lexaria SNAC-inclusive DHT-sema studies such as Human Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2; which, incidentally, also evidenced noteworthy safety and tolerability profiles).
The results of this Study are expected to be carefully reviewed by the pharmaceutical industry in order to evaluate the possibility of entering into commercial relationships focused on Lexaria?s proprietary DehydraTECH technology. This Study explores several new DehydraTECH enhancements not previously evaluated, which include but are not limited to the following 2 main improvements: (1) First, an oral tablet DHT-sema composition will be used by Lexaria for the first time, as opposed to only the capsule compositions included in all the company previous DHT glucagon-like peptide-1 (?GLP-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 the active ingredient ?
semaglutide ? into the human body. For the first time ever, Lexaria has attempted to mimic and integrate certain properties of this Rybelsus/Wegovy tablet delivery modality into its DHT-sema tablets.
(2) 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 dosing duration of the Study is expected to be long enough to reach so-called steady-state, which is when drug concentrations in the body reach a constant concentration. Earlier DHT-sema human pilot studies GLP-1-H24-1 and GLP-1-H24-2, as noted above, that Lexaria conducted in 2024 and 2025 that also used SNAC (but did not use tablets), were limited by single-dose study designs; 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 the Pre-Dosing Tasks have been achieved. Based on the expected timelines, Lexaria anticipates dosing to begin in mid-June.
The Study is fully funded from existing corporate resources.
