STOCK TITAN

Lexaria to Begin New Human Clinical Study in GLP-1

(Positive)

Lexaria (NASDAQ:LEXX) signed contracts with a CRO to run Human Pilot Study #7 (GLP-1-H26-7) evaluating two oral DehydraTECH-semaglutide (DHT-sema) formulations versus Wegovy tablets.

The 5-week, three-arm parallel study will test tablet and capsule DHT-sema with SNAC under fasted conditions, aiming to assess safety, tolerability and pharmacokinetics; ethics approval is pending and the study is fully funded from corporate resources.

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Positive

  • Contracts signed with CRO to conduct Human Pilot Study #7
  • Study uses 5-week, three-arm parallel design to assess safety and PK
  • First-time use of a DHT-sema oral tablet formulation
  • First multi-week human evaluation of DHT-sema formulations containing SNAC
  • Study fully funded from existing corporate resources

Negative

  • Independent ethics approval is still pending before patient recruitment
  • No PK, safety, or efficacy results available yet from this study
  • Prior DHT-sema studies were single-dose, limiting comparative multi-dose data

Market Context

This announcement outlines a new 5-week human pilot GLP-1 study comparing DehydraTECH-semaglutide ta...
Analysis

This announcement outlines a new 5-week human pilot GLP-1 study comparing DehydraTECH-semaglutide tablets and capsules, both using SNAC, against Wegovy tablets under fasted conditions. It builds on prior Phase 1b work showing reduced adverse events versus Rybelsus and adds multi-dose, steady-state data. Investors may watch for ethics approval timing, enrollment progress, and whether pharmacokinetic performance approaches commercial benchmarks such as Rybelsus and Wegovy.

Key Figures

Study duration: 5-week Study arms: 3 arms DHT-sema compositions: 2 compositions +5 more
8 metrics
Study duration 5-week Planned parallel group human pilot Study #7 (GLP-1-H26-7)
Study arms 3 arms Safety, tolerability and PK comparison vs Wegovy tablets
DHT-sema compositions 2 compositions Oral DehydraTECH-semaglutide vs Wegovy tablets
AE reduction 48% reduction Total adverse events for DHT-semaglutide vs Rybelsus (Phase 1b)
GI AE reduction 55% reduction Gastrointestinal adverse events vs Rybelsus in Phase 1b
Interim AE reduction 36.5% / 43.5% Overall and GI AE reductions for DHT-semaglutide vs Rybelsus (8-week interim)
Worldwide patents 56 patents Total patents reported in 2025 annual CEO letter
Capital raised 2025 $9.5M Funds raised in 2025 as per annual CEO letter

Previous Clinical trial Reports

3 past events · Latest: Dec 23 (Positive)
Same Type Pattern 3 events
Date Event Sentiment 24h Move Catalyst
Dec 23 Phase 1b results Positive -29.1% Phase 1b GLP-1-H24-4 met primary safety and tolerability endpoint vs Rybelsus.
Jul 28 Interim trial data Positive +20.0% Positive 8-week interim Phase 1b GLP-1-H24-4 data with reduced adverse events.
Nov 13 Ethics approval Positive -9.1% Ethics board approval for 12-week Phase 1b DehydraTECH GLP-1 study in diabetes and weight loss.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical GLP-1 news has produced mixed reactions: one strong gain, but two notable selloffs despite positive or de-risking updates.

Recent Company History

Over recent GLP-1 clinical milestones, Lexaria progressed from ethics approval in Nov 2024 for its Phase 1b GLP-1-H24-4 study, to positive interim 8-week data in Jul 2025, then to successful primary endpoint achievement in Dec 2025. Those updates generally highlighted improved safety and tolerability versus Rybelsus®. However, share reactions varied, with both gains and declines, showing that positive clinical details did not always translate into supportive trading.

Key Terms

glp-1, pharmacokinetic, semaglutide, salcaprozate sodium, +3 more
7 terms
glp-1 medical
"previous DHT glucagon-like peptide-1 ("GLP-1") studies."
GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.
pharmacokinetic medical
"assess safety & tolerability and pharmacokinetic ("PK") properties"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
semaglutide medical
"active ingredient - semaglutide - into the human body."
Semaglutide is a medication originally developed to help manage blood sugar levels in people with diabetes, but it also promotes weight loss. It works by mimicking a natural hormone that helps control appetite and insulin release. For investors, its potential to influence healthcare and weight management markets makes it a significant product in the pharmaceutical industry.
salcaprozate sodium medical
"compare salcaprozate sodium ("SNAC")-inclusive DHT-sema tablet and capsule"
Salcaprozate sodium is a pharmaceutical absorption enhancer — a small, water‑soluble compound added to oral drug formulations to help large, normally injected molecules cross the stomach lining into the bloodstream. Like a temporary key that opens a door without changing the lock, it can turn injectable medicines into convenient pills, which can expand patient use, simplify manufacturing and distribution, and materially affect a drug’s market potential and licensing or royalty value to investors.
steady-state medical
"long enough to reach so-called steady-state, which is when drug concentrations"
Steady-state is the condition when a process has reached a consistent, ongoing level — for example when a drug’s concentration in the body, a factory’s output, or a company’s revenue flow stops changing significantly from day to day. Investors care because steady-state indicates predictability: it helps estimate long-term performance, safety and capacity limits, and supports reliable forecasts and valuations, much like knowing a car’s cruising speed rather than its speed while accelerating.
adverse events medical
"48% reduction in total adverse events for the DHT-semaglutide arm"
Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.
capsule formulations technical
"DHT-sema tablet and capsule formulations to commercially available Wegovy"
Capsule formulations are medicines where the active drug is enclosed inside a small, usually dissolvable shell made from gelatin or plant-based materials; the interior can be powder, granules, pellets or liquid. Investors care because the capsule type influences manufacturing costs, shelf life, dosing accuracy, patient acceptance and regulatory review—like choosing packaging for a consumer product, the form can affect ease of use, production scale and market sales.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Contracts signed for Human Pilot Study #7 (GLP-1-H26-7)

KELOWNA, BC / ACCESS Newswire / April 1, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX), (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the engagement of the contract research organization ("CRO") to execute and report on its Human Pilot Study #7 (GLP-1-H26-7) that will evaluate 2 oral DehydraTECH-semaglutide ("DHT-sema") compositions against commercially available Wegovy® tablets (the "Study").

Contracts with the CRO have been signed and submissions are currently being prepared to obtain the required ethics approval from an independent review board.

Study design is virtually complete and is expected to be a 5-week parallel group design, investigating 3 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, under fasted pre-dose conditions. Lexaria hopes to preserve the superior safety & tolerability profiles as evidenced in previous Lexaria GLP-1 studies such as GLP-1-H25-4, combined with PK performance that matches or exceeds that of the commercial oral tablet brands Ryblesus® and Wegovy®.

If successful, the Study results will be additive to an already impressive data set aimed at generating interest from pharmaceutical partners seeking to enter into commercial relationships encompassing Lexaria's proprietary DehydraTECH technology.

What's New?

This Study explores several new DehydraTECH enhancements not previously evaluated, which include but are not limited to the following 2 main improvements:

(1) First, an oral tablet DHT-sema composition is being used by Lexaria for the first time, as opposed to the capsule compositions included in all our previous DHT glucagon-like peptide-1 ("GLP-1") studies. Novo Nordisk's® Rybelsus® and Wegovy® oral semaglutide medications both use specially formulated tablets designed to temporarily adhere to the stomach lining and disintegrate and dissolve releasing agents in a focal manner that aids in optimizing absorption of the active ingredient - semaglutide - into the human body. For the first time ever, Lexaria has attempted to mimic certain properties of this Rybelsus®/Wegovy® tablet delivery modality into its DHT-sema tablets.

(2) Second, both the Lexaria DHT-sema tablet and capsule test articles will be formulated with SNAC, which will be the first time these formulations are evaluated over a multi-dose, multi-week time period in humans. The 5-week duration of the Study is expected to be long enough to reach so-called steady-state, which is when drug concentrations in the body reach a constant concentration. Earlier DHT-sema human pilot studies that Lexaria conducted in 2024 and 2025 that also used SNAC (but did not use tablets), were limited by single-dose study designs; therefore, of much shorter duration. Novo Nordisk's branded Rybelsus® and Wegovy® semaglutide based products are both formulated with SNAC.

Lexaria will update its stakeholders once the ethics board approval for the Study has been achieved, at which time patient recruitment can begin. The Study is fully funded from existing corporate resources.

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 65 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 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on ACCESS Newswire

FAQ

What is Lexaria announcing with Human Pilot Study #7 (GLP-1-H26-7) on April 1, 2026?

Lexaria announced contracts with a CRO to run Human Pilot Study #7 comparing DHT-sema to Wegovy tablets. According to Lexaria, the 5-week, three-arm parallel study will assess safety, tolerability and pharmacokinetics of tablet and capsule DHT-sema with SNAC under fasted conditions.

How does the DHT-sema tablet in LEXX's April 1, 2026 study differ from prior DHT GLP-1 studies?

The study uses an oral DHT-sema tablet for the first time, not just capsules. According to Lexaria, the tablet mimics properties of Rybelsus/Wegovy tablets and will be evaluated alongside capsule formulations containing SNAC over multiple doses.

What role does SNAC play in Lexaria's LEXX GLP-1-H26-7 study design?

SNAC is included in both tablet and capsule test articles and will be evaluated over multiple weeks. According to Lexaria, this is the first multi-dose human evaluation of their SNAC-formulated DHT-sema to reach expected steady-state concentrations.

When will patient recruitment begin for Lexaria's LEXX GLP-1-H26-7 study?

Patient recruitment will begin after independent ethics board approval is achieved. According to Lexaria, submissions are being prepared now and the company will update stakeholders once ethics approval is granted.

Will Lexaria fund Human Pilot Study #7 from existing resources according to the April 1, 2026 announcement?

Yes. According to Lexaria, the Study is fully funded from existing corporate resources. The company reported no additional external financing is required to initiate the trial pending ethics approval.