Lexaria Bioscience Announces Final Results from Human Pilot Study #5
Kelowna, British Columbia — February 5, 2026 — Leads & Copy — Lexaria Bioscience Corp. (Nasdaq: LEXX) has announced the final results from Human Pilot Study #5 (GLP-1-H25-5), which compared oral DehydraTECH-liraglutide (“DHT-LIR”) capsules to injected Saxenda® branded liraglutide (“SAX-LIR”).
The company is further examining the pursuit of the world’s first oral liraglutide product, according to a press release.
Lexaria reported primary results from this study on June 11, 2025, including a 22.7% reduction in adverse events (“AEs”) with DHT-LIR compared to SAX-LIR, with a 67% reduction in nausea and a 31% reduction in overall gastrointestinal AEs. Measurements of blood glucose, insulin and body weight were not statistically significantly different across most time points.
Weight loss was experienced by 9 out of 10 people in each study arm and slightly higher in the Saxenda® study arm; though weight loss was not a primary goal of this study with the very short treatment period of only 1 week with each treatment. The primary endpoint of the study was evaluating the safety and tolerability of the oral DHT-LIR capsules relative to injected SAX-LIR, and it was successfully met with signs of improved safety and tolerability performance by the DHT-LIR.
Richard Christopher, CEO of Lexaria, said the company is extremely pleased with the results of Human Pilot Study #5. He added that, in addition to achieving the study’s primary safety and tolerability endpoint, they also demonstrated that oral DehydraTECH-liraglutide functioned comparably to traditionally injected liraglutide, consistent with regulatory development pathway objectives. Christopher also said the company has compiled compelling evidence to further support examining the pursuit of the world’s first oral liraglutide product.
Since mid-2025, Lexaria and its third-party bioanalytical service providers have invested considerable time and expertise in attempting to determine the precise pharmacokinetic (“PK”) blood liraglutide quantitation and profiling results from the study. This included the use of two different manufactured brands of commercially available ELISA (enzyme-linked immunosorbent assay) test kits. Throughout the course of this bioanalytical work, challenges were encountered with background signal noise detection which complicated the ability to accurately capture blood liraglutide measurements in both the SAX-LIR and DHT-LIR study samples. The background signal noise is believed to be attributable to the fact that liraglutide and other peptide drugs are commonly known to bind with, and have poor separation from, albumin; a naturally occurring protein present in human blood plasma.
PK testing from the study was limited to exploratory visualization of the raw ELISA signals which demonstrated broadly similar temporal patterns between the DHT-LIR and the SAX-LIR. The visualization of the similar signal patterns of the two treatments is consistent with the instances of functional comparability otherwise demonstrated in the study, pursuant to Lexaria’s regulatory development pathway objectives. Lexaria considers this to be particularly noteworthy given the fact that the DHT-LIR dose quantity studied was conservatively low for this initial human investigation, relative to that of the SAX-LIR, with room for possibly increasing the dose if necessary, in potential future studies.
The two most important strategic objectives of this study were to discover whether the DehydraTECH processing of liraglutide would work sufficiently enough to potentially allow for an oral version of the drug to be compared to the current injection-only delivery method; and to demonstrate that oral DHT-LIR could produce comparable functional results to the injected version, allowing for an expedited FDA regulatory development pathway known as a 505(b)(2) new drug application (the “505(b)(2) Pathway”) that is available when an alternate version of a drug retains certain similar performance characteristics as an earlier-approved version of that same drug.
Lexaria notes that Saxenda® is owned by Novo Nordisk, who also sells an oral tablet form of the blockbuster GLP-1 drug semaglutide under the brand name Rybelsus®. Lexaria also noted that the salcaprozate sodium (“SNAC”) delivery technology that Novo Nordisk acquired for $1.8 billion utilized within the Rybelsus® tablet was found by other researchers to be unfavorable for co-formulation of an oral version of liraglutide. Liraglutide went off patent in 2024 and is now offered in a generic injectable format by Teva Pharmaceuticals and others.
Lexaria says it feels this is an unmet market need which DehydraTECH may empower.
Lexaria has had, and intends to continue, discussions with pharmaceutical companies regarding the possibility of collaborating in pursuing a 505(b)(2) Pathway to enable commercialization of an oral DHT-LIR product. Further details on prospective next steps in development of the DHT-LIR product candidate will be provided when available in due course.
Study GLP-1-H25-5 was a pilot, cross-over investigation in 10 overweight (average weight 73 Kg, average body mass index 26.81) volunteers. SAX-LIR injection was administered daily at its commercially available starting dose of 0.6 mg for 7 days with a follow-up evaluation at day 8, compared to oral DHT-LIR (45 mg) also administered daily for 7 days with an identical day 8 evaluation. All drug administrations were performed after an overnight fast. Oral administration was accomplished with a 50 mL glass of water. The DHT-LIR 45 mg dose equated to a 75-fold multiple of the 0.6 mg SAX-LIR dose exposure tested. This dosing multiple was selected conservatively relative to the 98 to 196-fold dosing multiple currently used with Novo Nordisk’s Rybelsus® branded semaglutide, whereby a 14 mg Rybelsus® daily dose is considered to be bioequivalent to a 0.5-1.0 mg once-weekly dose of their Ozempic® or Wegovy® branded semaglutide injectable products. Accordingly, Lexaria notes that there is arguably room to further titrate the DHT-LIR oral dose upwards in prospective future studies, in an effort to most closely match the effectiveness of the injectable regimen consistent with its 505(b)(2) Pathway strategy.
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 60 patents granted and additional patents pending worldwide.
Source: Lexaria Bioscience Corp.
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