Lexaria Releases DHT-LIR Study Results Showing Improved Safety

Lexaria Bioscience announced final results from Human Pilot Study #5, which compared oral DehydraTECH-liraglutide capsules to injected Saxenda branded liraglutide. The primary results from this Study were issued on June 11, 2025, at which time Lexaria reported a 22.7% reduction in adverse events with DHT-LIR as compared to the SAX-LIR, with a particular emphasis on a 67% reduction in nausea and a 31% reduction in overall gastrointestinal AEs. The differences in measurements of blood glucose, insulin and body weight across most time points were not statistically significantly different, with remarkable similarity in many areas and slight differences in others. 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. Evaluating the safety and tolerability of the oral DHT-LIR capsules relative to injected SAX-LIR was the primary endpoint of this Study. This objective was met with clear signs of improved safety and tolerability performance by the DHT-LIR. Since mid-2025, Lexaria and its third-party bioanalytical service providers have invested considerable time and expertise in attempting to determine the precise pharmacokinetic blood liraglutide quantitation and profiling results from the Study. This included the use of two different manufactured brands of commercially available ELISA test kits. Throughout the course of this bioanalytical work, challenges were encountered with background signal noise detection, which complicated our 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. In light of this issue, the PK testing from the Study was limited to exploratory visualization of the raw ELISA signals which, nonetheless, over time 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 that is available when an alternate version of a drug retains certain similar performance characteristics as an earlier-approved version of that same drug. In both these respects, the results from this Study have shown tremendous promise while also evidencing tolerability advantages from a user appeal perspective.