Lexaria Bioscience Corp. (LEXX, LEXXW) announced that it has achieved the safety and tolerability-based final primary endpoint on Phase 1b,12-week chronic study GLP-1-H24-4 on 4 DehydraTECH study arms relative to the Rybelsus control study arm. In addition, it updated the significant Secondary endpoint results based on glycated haemoglobin and body weight.
The Study GLP-1-H24-4 investigated 126 overweight, obese, pre-diabetic and/or type-2 diabetic human volunteers/patients. The main goal in this study was to assess the impact on safety and tolerability based on the incidence of treatment-emergent adverse events or AE.
The 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 compared with commercially available Rybelsus, the only approved oral GLP-1 medication, serving as the study's positive control group.
The primary endpoint of the Study was met, indicating that all 4 DHT test articles appeared safe and well-tolerated. Specifically, the data showed a 47.9% reduction in the total number of AEs with DHT-semaglutide compared with Rybelsus.
Additionally, a statistically significant 54.9% reduction in gastrointestinal AEs with DHT-semaglutide compared with Rybelsus was observed. Notably, DHT-semaglutide AE per cent reductions were higher at the end of the Study than at the 8-week interim analysis.
The major secondary efficacy endpoints of the Study included assessments of the magnitude of decrease in glycated haemoglobin (HbA1c), a primary blood test for blood sugar levels, and body weight.
The findings for each variable at both week 12 and week 16 for DHT formulation and DHT composition were that DHT-semaglutide showed modest reductions that were not statistically different from those of Rybelsus in reducing HbA1c.
On the other hand, bodyweight reduction performance was improved for the Rybelsus control arm compared to all DHT arms at both the week 12 and week 16 evaluations, which remains consistent with the previously reported 8-week interim analysis.
In parallel, Lexaria will provide the dataset to the pharmaceutical company with which it has a Material Transfer Agreement, that was recently extended to April 30, 2026, to accommodate the time required for PharmaCo's receipt and current dataset review.
Also, Lexaria highlighted the chemistry of salcaprozate sodium or SNAC in its DHT-semaglutide formulations, which were initially tested in its previous human clinical studies , GLP-1-H24-1, and GLP-1-H24-2, but were not included in the current Study.
To accommodate the large volume of data captured in study GLP-1-H24-4, additional secondary and exploratory endpoint results are expected next week.
In addition, Lexaria reported that financings totalling about $7.5 million across two transactions, each at a share price high at the time, since August 31, have created a runway for prospective new 2026 development opportunities.
Moving forward, Lexaria intends to consider the options for prospective follow-on human clinical testing of a DehydraTECH + SNAC (salcaprozate sodium) + semaglutide composition compared to Rybelsus, to expand and build upon the learnings from human studies GLP-1-H24-1, GLP-1-H24-2, and the current GLP-1-H24-4.
Over the past year, LEXX traded between $0.4800 and $2.43.
On Tuesday, LEXX closed trading 8.01% lower at $0.62.
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December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.