Primary Endpoint Successfully Achieved in Lexaria's Phase 1b Study GLP-1-H24-4
DehydraTECH-semaglutide reduced overall side effects by 48% as compared to Rybelsus®
DehydraTECH-semaglutide reduced gastrointestinal side effects by 55% as compared to Rybelsus®
Recent financings create runway for prospective new 2026 development opportunities
KELOWNA, BC / ACCESS Newswire / December 23, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following final primary and major secondary efficacy endpoint results update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the " Study " or the " Lexaria Study "), recently completed in Australia, focusing on 4 DehydraTECH ® ( "DHT" ) study arms relative to the Rybelsus® control study arm.
"We are extremely pleased to not only have successfully achieved our primary endpoint," stated Richard Christopher, CEO of Lexaria, "but to have also demonstrated obvious superiority in reducing unwanted side effects by as much as approximately half as compared to the world's only approved oral-based GLP-1 medication, Rybelsus ® . The receipt of the results allows us to now relay the dataset to our Material Transfer Agreement partner."
"The final study results follow our recent financing activities," Mr. Christopher continued. "We are thrilled to have opportunistically raised a gross total of $7.5 million over two transactions, each at share price high points at the time, since our fiscal year-ended on August 31, 2025. As previously reported, we had limited resources remaining ($1.8 million in cash on hand as of August 31, 2025) which hindered our ability and runway to proceed forward with our DehydraTECH research and partnering efforts. The financings allow us to fund prospective new development opportunities for the entirety of calendar 2026, the details of which are in the process of being finalized and will be forthcoming in due course."
Adverse Events
After the full 12 weeks of treatment, followed by a 4-week follow-up period (16-week study duration overall), all 4 DHT test articles appeared to be safe and well tolerated thus meeting the primary endpoint objective of the Study. Each of the DHT arms had lower rates of overall treatment emergent adverse events (" AEs ") and gastrointestinal (" GI ") AEs compared to the Rybelsus ® control arm:
GLP-1-H24 EOS Results | DHT-CBD 250 mg BID x 12 weeks (Arm 1; n=27) | DHT-semaglutide 3.5 mg QD x 4 weeks followed by 7 mg QD x 8 weeks (Arm 2; n=24) | DHT-CBD 250 mg BID with DHT-semaglutide 3.5 mg QD x 12 weeks (Arm 3; n=25) | Rybelsus ® 3 mg QD x 4 weeks followed by 7 mg QD x 8 weeks (Arm 4; n = 25) | DHT-tirzepatide 20 mg QD x 4 weeks followed by 40 mg x 8 weeks (Arm 5; n=25) |
Persons with at least 1 AE | 88.9% | 83.3% | 92.0% | 100% | 76.0% |
Total AEs | 105 | 73 | 86 | 140 | 128 |
Total AEs as a % of Control | 75.0% | 52.1% | 61.4% | N/A | 91.4% |
Total GI AEs | 21 | 32 | 31 | 71 | 28 |
GI AEs as a % of Control | 29.6% | 45.1% | 43.7% | N/A | 39.4% |
Nausea | 6 | 10 | 3 | 21 | 3 |
Vomiting | 0 | 2 | 2 | 6 | 0 |
Diarrhea | 7 | 6 | 10 | 15 | 12 |
All other GI AEs | 8 | 14 | 16 | 29 | 13 |
n = number of patients included in each study group for safety and tolerability assessments
Abbreviations: EOS: End of Study (week 16); BID: twice daily; CBD: cannabidiol; QD: once daily.
Of the DHT formulations evaluated, DehydraTECH-semaglutide (" DHT-semaglutide ") was the top performer in total AE reductions. There was a 47.9% reduction in the total quantity of AEs derived from DHT-semaglutide vs. Rybelsus ® . There was also a statistically significant (nominal p-value <0.05) 54.9% reduction in GI AEs from DHT-semaglutide vs. Rybelsus®. It should be noted that the DHT-semaglutide AE percent reductions were higher at the end of the Study than they were at the 8-week interim analysis mark previously reported upon .
It is also noteworthy that there were marked reductions in GI AEs for all 4 DHT treatment arms relative to Rybelsus ® , most notably in the instances of nausea, vomiting and diarrhea.
HbA1c and Bodyweight
Assessments of the magnitude of decreases in glycated haemoglobin (" HbA1c "), as a primary blood test for blood sugar levels, and body weight were the major secondary efficacy endpoints of the Study. The findings for each variable at both the week 12 and week 16 points were as follows:
GLP-1-H24 12-week and EOS Results | DHT-CBD 250 mg BID x 12 weeks (Arm 1; n=27) | DHT-semaglutide 3.5 mg QD x 4 weeks followed by 7 mg QD x 8 weeks (Arm 2; n=24) | DHT-CBD 250 mg BID with DHT-semaglutide 3.5 mg QD x 12 weeks (Arm 3; n=25) | Rybelsus ® 3 mg QD x 4 weeks followed by 7 mg QD x 8 weeks (Arm 4; n = 25) | DHT-tirzepatide 20 mg QD x 4 weeks followed by 40 mg x 8 weeks (Arm 5; n=25) |
HbA1c | Wk 12 -0.08% (range -0.4 to +0.3%) | Wk 12 -0.12% (range -0.9 to +0.3%) | Wk 12 -0.05% b (range -0.5 to +0.3%) | Wk 12 -0.24% (range -0.6 to +0.4%) | Wk 12 +0.07% b (range -0.7 to +0.6%) |
EOS Wk 16 +0.01% b (range -0.3 to +0.2%) | EOS Wk 16 -0.08% (range -0.5 to +0.3%) | EOS Wk 16 +0.03% b (range -0.3 to +0.4%) | EOS Wk 16 -0.14% (range -0.4 to +0.3%) | EOS Wk 16 +0.12% b (range -0.8 to +0.5%) | |
Bodyweight | Wk 12 +0.06 Kg or -0.13% b (range -4.3 to +5.9 Kg) | Wk 12 -0.87 Kg or -0.94% b (range -7.4 to +5.0 Kg) | Wk 12 -0.90 Kg or -0.93% b (range -6.8 to +4.2 Kg) | Wk 12 -5.29 Kg or -5.45% (range -12.4 to -0.1 Kg) | Wk 12 +0.67 Kg or +0.69% b (range -10.1 to +10.3 Kg) |
EOS Wk 16 +0.77 Kg or +0.68% b (range -7.7 to +4.2 Kg) | EOS Wk 16 -1.20 Kg or -1.31% b (range -8.7 to +6.1 Kg) | EOS Wk 16 -0.59 Kg or -0.65% b (range -7.4 to +5.3 Kg) | EOS Wk 16 -4.95 Kg or -5.14% (range -11.8 to +2.5 Kg) | EOS Wk 16 +0.77 Kg or +0.82% b (range -11.6 to +8.8 Kg) |
n = number of patients included in each study group for HbA1c and body weight efficacy assessments
Abbreviations: EOS: End of Study (week 16); Wk: week; BID: twice daily; CBD: cannabidiol; QD: once daily.
b Instances where nominal p-values were < 0.05 for least-square mean changes relative to Rybelsus ® control arm upon mixed model for repeated measures (MMRM) analysis
The DHT-semaglutide formulation was, again, the top performing DHT composition as compared to the Rybelsus ® control upon these efficacy analyses. For the primary efficacy endpoint of HbA1c reduction, the percent reduction achieved was insignificantly different statistically (p > 0.05) than that of Rybelsus ® , meaning that performance was considered comparable between the two test articles. Of note, evidence suggests that even small reductions in HbA1c can improve cardiovascular outcomes in overweight or obese individuals without diabetes, similar to the population in this Study.
The bodyweight reduction performance, on the other hand, was improved for the Rybelsus ® control arm versus all DHT arms at both the week 12 and week 16 evaluations, as was also witnessed at the 8-week interim analysis timepoint previously reported. Of note, a comparison to published Rybelsus ® bodyweight reduction performance levels in Novo Nordisk's ® Pioneer 1 phase 3a randomized study conducted in 703 patients with type 2 diabetes, with similar daily doses of Rybelsus ® semaglutide administered after 26 weeks of dosing, revealed much lower bodyweight reduction performance which was comparable to that achieved with DHT-semaglutide in the current Study:
Pioneer 1: 26-Week Final Results | 3 mg Rybelsus® | 7 mg Rybelsus® | 14 mg Rybelsus® |
Body Weight Baseline = 88.1kg | -1.32 kg or -1.5% | -2.02 kg or -2.3% | -3.26 kg or -3.7% |
The reasons for the apparent anomaly of exceptionally high Rybelsus ® bodyweight performance levels in the current Study are presently unknown, but likely related to the differing patient population and/or small sample size of the Lexaria Study, where it is notable that the range as tabulated above in bodyweight reductions was wide for all arms in the Lexaria Study. The historical studies conducted in thousands of persons are more likely to be representative of real-world performance.
Overall Conclusions and Next Steps
Study GLP-1-H24-4 met its primary endpoint objectives showing good safety and tolerability of all DHT test articles with clear reductions in total and GI-specific AEs relative to the Rybelsus ® control arm. The Study demonstrated positive findings across numerous parameters with comparability, and in some instances, superiority to the Rybelsus ® control arm.
Based on the findings from this Study, Lexaria considers the DHT-semaglutide test article to be most worthy of continued investigation for the therapeutic indication studied. However, it would seem most prudent for any such work to include the salcaprozate sodium ( "SNAC" ) ingredient chemistry present in Lexaria's DHT-semaglutide formulations originally tested in its previous human clinical studies GLP-1-H24-1 and GLP-1-H24-2 , (Human Pilot Studies #1 and #2), but not included in the current Study. These previous human clinical studies evidenced the strongest DHT-semaglutide efficacy performance superior to the Rybelsus ® control used therein, while also maintaining improvements in safety and tolerability relatively speaking with the DHT-semaglutide formulation studied.
Moving forward, Lexaria intends to consider its options to perform prospective follow on human clinical testing with a DehydraTECH + SNAC + semaglutide composition compared to Rybelsus ® accordingly, to expand and build upon the learnings in aggregate from studies GLP-1-H24-1, GLP-1-H24-2 and GLP-1-H24-4. Details will be provided on this if/when Lexaria formalizes plans to perform such a study.
In parallel, now that public release of final results from study GLP-1-H24-4 has occurred, Lexaria will proceed with relaying the dataset to the pharmaceutical company ( "PharmaCo" ) that Lexaria has a Material Transfer Agreement ( "MTA" ) in place with. As previously announced , this MTA was recently extended through April 30, 2026 to accommodate the time needed for PharmaCo's receipt and review of this dataset, after which time further information will be provided.
Lexaria remains hopeful that achievement of its primary endpoint in the current Study, with DehydraTECH evidencing superior safety and tolerability and a significant reduction in GI side effects especially relative to Rybelsus ® , will be considered attractive and compelling to PharmaCo in its deliberations about potential next steps in its relationship with Lexaria. This would be consistent with the pharmaceutical industry's strong appetite in the related therapeutic sectors for improvements in unwanted side effects as Lexaria previously reported .
As noted above, Lexaria was pleased to have recently raised additional capital through financings intended to allow it to fund prospective new development opportunities through the entirety of calendar 2026; the details of which are in the process of being finalized and will be forthcoming in due course. Deployment of these funds may include, but not be limited to, progressing its prospective further human clinical testing upon DehydraTECH + SNAC + semaglutide as noted above, as well as, supporting other complementary research and development program work in the Glucagon-Like Peptide-1 ( "GLP-1" ) sector.
About the Study
Study GLP-1-H24-4 investigated 126 overweight, obese, pre-diabetic and/or type-2 diabetic human volunteers/patients. The primary endpoint in this study was to assess impacts upon safety and tolerability based on the incidence of treatment emergent adverse events. This Study initially included three DehydraTECH arms testing DehydraTECH-CBD, DehydraTECH-semaglutide and a combination of DehydraTECH-CBD with DehydraTECH-semaglutide. Performance across these three initial study arms was monitored compared to commercially available Rybelsus ® as the Study positive control group. Of note, the DehydraTECH-semaglutide composition evaluated used pure semaglutide processed without inclusion of the SNAC ingredient found in the Rybelsus ® composition differing, therefore, from the DehydraTECH-semaglutide composition previously tested by Lexaria in its studies GLP-1-H24-1 and GLP-1-H24-2 that used reformulated commercially available SNAC-inclusive Rybelsus ® as the semaglutide active substance input. In addition, this Study was expanded after initiation to incorporate an orally delivered DehydraTECH-tirzepatide arm to assess safety, tolerability and effectiveness in an effort to potentially advance the findings discovered with Lexaria's previous DehydraTECH-tirzepatide human pilot study GLP-1-H24-3. Of note, however, the DehydraTECH-tirzepatide composition evaluated in study GLP-1-H24-4 used pure tirzepatide as the active substance input instead of reformulated commercially available Zepbound ® differing, therefore, compared to the composition utilized in study GLP-1-H24-3.
In an attempt to accommodate the large amount of data captured in study GLP-1-H24-4, additional non-primary (secondary/exploratory) endpoint results are expected to be released next week.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the intended use of proceeds from the offering and relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, market and other conditions, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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