DehydraTECH-semaglutide / Lexaria Biosci - LARVOL DELTA

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