DehydraTECH-semaglutide / Lexaria Biosci - LARVOL DELTA

Lexaria's Human Study GLP-1-H26-7 Has Begun Dosing on Schedule (Investing News Network (INN)) - "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...The Study is investigating three separate arms to assess safety & tolerability as well as PK properties that will compare SNAC-inclusive, DHT-sema compositions formulated in both tablet and capsule formats to commercially available Wegovy tablets. The Study is being conducted under fasted pre-dose conditions similar to the advised administration criteria of Novo's oral semaglutide products."

Trial status • Obesity

Lexaria Receives Independent Review Board Approval to Begin Human Pilot Study #7 (Investing News Network (INN)) - "Lexaria is seeking to preserve the superior safety and tolerability profiles evidenced in its previous glucagon-like peptide-1 ('GLP-1') studies such as Human Study #4 (GLP-1-H25-4), combined with pharmacokinetic ('PK') performance that matches or exceeds the Wegovy tablet control over a 5-week period. Previous Lexaria salcaprozate sodium ('SNAC')-inclusive DHT-sema single dose studies such as Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2) evidenced PK performance that matched or exceeded the Rybelsus control arm and also evidenced noteworthy safety and tolerability profiles...Third-party independent lab quality-control ('QC') testing of those test articles is currently underway and is expected to be complete in early June."

New trial • Obesity

Lexaria Updates Progress on Human Study #7 (Yahoo Finance) - "Submissions have now been entered to formally request the required ethics approval from an independent review board...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 five-week parallel group design, investigating three 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."

New trial • Obesity

Lexaria Launches New Study to Examine Next-Generation GLP-1 Drugs (Yahoo Finance) - "Lexaria Bioscience...is pleased to announce the engagement of the contract research organization ('CRO') to execute and report on its 2026 Animal Study #2 (GLP-1-A26-2) that will evaluate a number of formulation enhancements with two next-generation glucagon-like peptide-1 ('GLP-1') drugs in animals (the 'Study') to explore the potential for improved DehydraTECH performance as well as potentially stake new intellectual property claims....Contracts with the CRO have been signed; Study design has been completed; formulation manufacturing is underway; and dosing is expected to begin within 30 days."

Preclinical • Obesity

Lexaria's New Animal Study Aims to Expand Valuable Intellectual Property (ACCESS Newswire) - "Lexaria...is pleased to announce the engagement of the contract research organization ('CRO') to execute and report on its 2026 animal Study #1 (GLP-1-A26-1) that will evaluate a number of formulation enhancements using both DehydraTECH-semaglutide ('DHT-sema') glucagon-like peptide-1 ('GLP-1') compositions and DehydraTECH-CBD ('DHT-CBD') compositions to explore the potential for additional improved performance as well as stake new intellectual property ('IP') claims (the 'Study')...While final design parameters of this Study are ongoing, it is expected to utilize Sprague-Dawley rats with 8 to 11 separate arms evaluating a number of different novel compositions. Blood samples will be taken at multiple timepoints through an 8-24-hour post-dosing period to quantify the pharmacokinetic performance of each composition."

Preclinical • Obesity

Lexaria Bioscience Corp...announced it has signed contracts with a contract research organization to conduct Human Pilot Study #7, which will evaluate two oral DehydraTECH-semaglutide compositions against commercially available Wegovy tablets. (Streetinsider.com) - "The company is preparing submissions to obtain ethics approval from an independent review board. The study design is expected to be a 5-week parallel group investigation with three separate arms to assess safety, tolerability and pharmacokinetic properties under fasted conditions...The study will test both tablet and capsule formulations containing salcaprozate sodium, comparing them to Wegovy tablets....Lexaria will provide updates once ethics board approval is obtained and patient recruitment can begin. The study is funded from existing corporate resources."

Commercial • New trial • Obesity

Human Study GLP-1-H26-7 (ACCESS Newswire) - "With study design nearing completion, this is expected to be a 5-week parallel group study consisting of 3 different arms with primary goals of establishing safety and tolerability, as well as pharmacokinetic ('PK') evaluation, comparing salcaprozate sodium ('SNAC')-inclusive DehydraTECH-semaglutide tablet and capsule compositions to the recently launched, commercially available Wegovy semaglutide tablets under fasted pre-dose conditions...Lexaria is aggressively working with its third-party service providers with the intent of beginning recruitment in this study as early as April. Ethics board submissions will be made as soon as possible. The Company will provide public updates when ethics board approval has been achieved. A final study report should be expected in Q4, 2026."

New trial • Obesity

Animal Study GLP-1-A26-1 (ACCESS Newswire) - "Animal Study GLP-1-A26-1 is expected to be a large, single-dose study with between 8-11 different arms. Blood samples are expected to be drawn over an 8-24-hour post-dose period to quantify the PK performance of the active ingredients. We currently expect to test various SNAC-inclusive DehydraTECH-semaglutide formulations with prospective formulation performance enhancements from our earlier glucagon-like peptide-1 ('GLP-1') related work; and in separate arms, test various DehydraTECH-cannabidiol formulations where similar enhancements may be beneficial for Lexaria's cannabidiol therapeutic program pursuits....Animal Study GLP-1-A26-1 is anticipated to begin by Q2, 2026 with a final study report expected near the end of Q3, 2026."

Preclinical • Obesity • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=148 | Completed | Sponsor: Lexaria Bioscience Corp. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

2026 Research & Development (ACCESS Newswire) - "Therefore, we have already started designing our next DHT-GLP-1 human study to leverage advanced, next-generation DHT oral formulations that no other company in the world possesses. Once we have finalized this study design, it will be announced and vigorously pursued. As currently envisioned, we would expect to complete this study during calendar 2026, and we can fully fund it using existing Company resources."

New trial • Obesity

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. (The Newswire) - "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 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."

Commercial • Type 2 Diabetes Mellitus

Lexaria Bioscience Corp…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. (The Newswire) - "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...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...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."

P1 data • Type 2 Diabetes Mellitus

Lexaria's Technology Supports Higher Levels of the GLP-1 Drug Semaglutide in Brain (ACCESS Newswire) - "The most intriguing finding from the Study was that Lexaria's DehydraTECH-FTS composition, across all doses tested (asterisked below), demonstrated a predominantly higher apparent trend in brain biodistribution (evidenced as fluorescent signal intensity upon whole brain imaging) than the Rybelsusequivalent composition and all Study controls. In fact, the 5mg DehydraTECH-FTS composition achieved higher brain semaglutide fluorescent signal intensity than the 15mg Rybelsus equivalent composition."

Preclinical • Obesity

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=148 | Active, not recruiting | Sponsor: Lexaria Bioscience Corp. | Recruiting ➔ Active, not recruiting | N=80 ➔ 148

Enrollment change • Enrollment closed • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Lexaria's Phase 1b GLP-1 Study Achieves Important "Last Patient Last Visit" Milestone (ACCESS Newswire) - "'Study work continues with full sample and data analyses currently underway in order to reach our late 2025 final reporting objective.'"

Enrollment closed • P1 data • Obesity • Type 2 Diabetes Mellitus

Lexaria Provides Positive Interim Results on Partial 8-week Data from Phase 1b, GLP-1-H24-4 Study (ACCESS Newswire) - P1b | N=148 | NCT06648031 | Sponsor: Lexaria Bioscience Corp. | "'We are extremely encouraged by the interim results received to date aligned with our primary study endpoint.'...Of note, every person taking Rybelsus in the Study experienced at least one AE. There was a 20.8% reduction in the overall number of persons experiencing an AE with DehydraTECH-semaglutide...vs. Rybelsus and a 36.5% reduction in the total quantity of AEs derived from DHT-semaglutide vs. Rybelsus. There was also a 43.5% reduction in GI AEs from persons taking DHT-semaglutide vs. Rybelsus....Furthermore, there is no statistically significant difference between the DHT-semaglutide and Rybelsus reductions in HbA1c witnessed at the 8-week point thus far in the Study (p=0.069). The 12-week HbA1c data should be more representative, and potentially, quite different from the 8-week data."

P1 data • Obesity • Type 2 Diabetes Mellitus

Lexaria Provides Update on Material Transfer Agreement with Pharmaceutical Company (ACCESSWIRE) - "Lexaria Bioscience Corp...provides this update on corporate developments...Lexaria today announces that the initial pre-clinical studies covered by the MTA, which examined pharmacokinetics in animals, have been performed. Results of that work will not be made public. In addition, Lexaria reports being informed by PharmaCO that they wish to review the pending safety (adverse events) and efficacy data from Lexaria’s ongoing independent human study GLP-1-H24-4 currently underway in Australia. We expect that data to become available beginning in Q3, 2025....The parties have agreed to continue their relationship under the MTA and to keep the temporary exclusive license active and in force until such time as the data from the Australian study becomes available and final decisions have been made, at which time further information will be provided."

Commercial • P1 data • Obesity • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Lexaria Bioscience Corp. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Lexaria Bioscience Corp.

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Lexaria Unveils Extensive Planned 2024 GLP-1 Study Program (ACCESSWIRE) - "Lexaria Bioscience Corp...announces a comprehensive planned applied research program to thoroughly evaluate DehydraTECH for the improved delivery of GLP-1 drugs....Chronic Dosing Animal Study: Targeted start March/April, 2024. This will be an obese rat diabetic-conditioned study similar to a previous Lexaria study, with approximately 12 study arms and 6-10 animals per arm....Human Pilot Study #2: Targeted start March/April, 2024. This human pilot study in up to 8 healthy volunteers, will study a single dose of oral ingested DehydraTECH-semaglutide capsules in a similar design to Human Pilot Study #1....Human Pilot Study #3: Targeted start in May/June, 2024. This human pilot study in up to 8 healthy human volunteers will study a single dose of oral ingested DehydraTECH-tirzepatide capsules (to be compound-formulated using Zepbound by Eli Lilly) to evaluate tolerability, PK, and blood sugar."

New trial • Preclinical • Diabetes • Metabolic Disorders • Obesity

Lexaria Unveils Extensive Planned 2024 GLP-1 Study Program (ACCESSWIRE) - "Chronic Dosing Human Study: Targeted start Q3, 2024. This chronic human study in 70 to 90 pre-diabetic and type-2 diabetic human patients will dose daily using oral DehydraTECH capsules for 12 weeks and will evaluate tolerability, PK, weight loss, blood sugar levels and more....All the programs described above are subject to change or substitution; dates are targets only; and some are subject to raising sufficient funds. All human studies will be investigator-initiated non-registrational studies and will require certain approvals before beginning. All studies will utilize third-party laboratories."

New trial • Diabetes • Metabolic Disorders

Exciting New Cures Possible from GLP-1 Diabetes, Weight-Loss Drugs (PRNewswire) - "Lexaria Bioscience is utilizing its patented DehydraTECH drug-delivery platform to improve the way active molecules enter the bloodstream upon oral ingestion. A pilot study showed that a DehydraTECH-processed form of blockbuster Rybelsus (a GLP-1) was more effective controlling blood glucose than standard Rybelsus. Lexaria recently received final data from the study and plans to conduct additional human studies during Q1 2024....In Q2 2024, Lexaria intends to study DehydraTECH-GLP-1 in a multiweek human clinical trial to examine both diabetes-related control (in part via reduced blood sugar levels) as well as weight loss and side effects."

New trial • Diabetes • Metabolic Disorders • Obesity