Lexaria Updates its Ongoing Human Study GLP-1-H24-4
Lexaria Bioscience (NASDAQ:LEXX) has announced completion of patient enrollment for its Phase 1b clinical study GLP-1-H24-4 in Australia. The 12-week study, investigating safety, diabetes control, and weight loss, has exceeded its initial enrollment targets with 24 patients per study arm versus the original target of 20, across all 5 study arms.
The achievement marks the 'last patient in' (LPI) milestone, with treatment expected to conclude in approximately twelve weeks. Following the treatment phase, the company will proceed with patient sample analyses, data compilation, analysis, and reporting.
Lexaria Bioscience (NASDAQ:LEXX) ha annunciato il completamento dell'arruolamento dei pazienti per il suo studio clinico di Fase 1b GLP-1-H24-4 in Australia. Lo studio di 12 settimane, che indaga sulla sicurezza, il controllo del diabete e la perdita di peso, ha superato i suoi obiettivi iniziali di arruolamento con 24 pazienti per braccio di studio rispetto all'obiettivo originale di 20, in tutti e 5 i bracci di studio.
Questo traguardo segna il 'ultimo paziente arruolato' (LPI), con il trattamento previsto per concludersi in circa dodici settimane. Dopo la fase di trattamento, l'azienda procederà con le analisi dei campioni dei pazienti, la raccolta dei dati, l'analisi e la redazione dei report.
Lexaria Bioscience (NASDAQ:LEXX) ha anunciado la finalización de la inscripción de pacientes para su estudio clínico de Fase 1b GLP-1-H24-4 en Australia. El estudio de 12 semanas, que investiga la seguridad, el control de la diabetes y la pérdida de peso, ha superado sus objetivos iniciales de inscripción con 24 pacientes por brazo de estudio frente al objetivo original de 20, en los 5 brazos de estudio.
Este logro marca el hito de 'último paciente inscrito' (LPI), con el tratamiento que se espera concluir en aproximadamente doce semanas. Tras la fase de tratamiento, la empresa procederá con el análisis de muestras de pacientes, la recopilación de datos, el análisis y la elaboración de informes.
Lexaria Bioscience (NASDAQ:LEXX)는 호주에서 Phase 1b 임상 연구 GLP-1-H24-4의 환자 등록 완료를 발표했습니다. 12주간의 연구는 안전성, 당뇨병 조절 및 체중 감소를 조사하며, 모든 5개의 연구 팔에서 원래 목표인 20명에 비해 각 연구 팔당 24명으로 초기 등록 목표를 초과 달성했습니다.
이 성과는 '마지막 환자 등록' (LPI) 이정표를 나타내며, 치료는 약 12주 후에 완료될 것으로 예상됩니다. 치료 단계가 끝난 후, 회사는 환자 샘플 분석, 데이터 수집, 분석 및 보고서를 진행할 예정입니다.
Lexaria Bioscience (NASDAQ:LEXX) a annoncé l'achèvement de l'inscription des patients pour son étude clinique de Phase 1b GLP-1-H24-4 en Australie. L'étude de 12 semaines, qui examine la sécurité, le contrôle du diabète et la perte de poids, a dépassé ses objectifs d'inscription initiaux avec 24 patients par bras d'étude par rapport à l'objectif initial de 20, dans les 5 bras d'étude.
Cette réalisation marque le jalon du 'dernier patient inclus' (LPI), le traitement devant se terminer dans environ douze semaines. Après la phase de traitement, l'entreprise procédera à l'analyse des échantillons de patients, à la compilation des données, à l'analyse et à la rédaction des rapports.
Lexaria Bioscience (NASDAQ:LEXX) hat den Abschluss der Patientenrekrutierung für seine Phase-1b-Studie GLP-1-H24-4 in Australien bekannt gegeben. Die 12-wöchige Studie, die Sicherheit, Diabeteskontrolle und Gewichtsverlust untersucht, hat ihre ursprünglichen Rekrutierungsziele mit 24 Patienten pro Studienarm im Vergleich zum ursprünglichen Ziel von 20 in allen 5 Studienarmen übertroffen.
Dieser Erfolg markiert den Meilenstein 'letzter Patient eingeschlossen' (LPI), wobei die Behandlung voraussichtlich in etwa zwölf Wochen abgeschlossen sein wird. Nach der Behandlungsphase wird das Unternehmen mit der Analyse von Patientenproben, der Datensammlung, der Analyse und der Berichterstattung fortfahren.
- Exceeded enrollment targets with 24 patients per arm vs. planned 20
- Study enrollment completed on schedule
- High participation interest reported
- None.
Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss
KELOWNA, BC / ACCESS Newswire / April 3, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study") underway in Australia.
Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Study was extremely high, so the Study overenrolled entering a total of 24 patients per Study arm versus the original target of 20. Completion of enrollment signifies the important "last patient in" ("LPI") clinical study milestone, meaning that treatment of all patients is expected to be completed roughly twelve weeks from now, to be followed by the series of patient sample analyses, data compilation, analysis and reporting.
"Lexaria is pleased to have reached LPI enrollment completion," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "Dosing is progressing nicely and, at this point, we are expecting the Study to complete on schedule."
About The Study
The Study is underway with 24 overweight, obese, pre- or type 2 diabetic patients for each of the 5 Study Arms, four of which are evaluating DehydraTECH-semaglutide, DehydraTECH-tirzepatide, and DehydraTECH-cannabidiol ("CBD"), with Study Arm 4 being the control arm. All drugs are being administered daily by oral tablet or capsule - there are no drug injections involved in this Study as Lexaria is promoting a change in the standard of care, moving away from injections and instead embracing oral DehydraTECH delivery.
Arm 1 of the Study is utilizing a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of
Arms 2 and 3 of the Study are using DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's® proprietary salcaprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.
Study Arm 5 will evaluate performance of DehydraTECH-tirzepatide, pursuant to the positive findings previously achieved and released for Human Pilot Study #3 (GLP-1-H24-3).
In its first-ever GLP-1 study in humans reported in January 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® alone. Also, in rodent study work reported in October 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption.
Lexaria has several important objectives for this Study:
Is DehydraTECH processed CBD, semaglutide, and/or tirzepatide safe over the Study duration in the Study population?
Does DehydraTECH-(pure) semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?
Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control over the Study duration?
Does DehydraTECH processing of pure semaglutide evidence reduced side effects during daily dosing for 12 weeks, as DehydraTECH processing of Rybelsus® seemed to achieve in a prior human study utilizing one single daily dose?
Lexaria expects to release the results of the Study when available, which is currently projected to be during in the fourth quarter of 2025.
About Lexaria Bioscience Corp. & DehydraTECH
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 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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 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, 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on ACCESS Newswire
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