Lexaria Bioscience's DehydraTECH Semaglutide Cuts Side Effects by 48% Compared to Rybelsus in Phase 1b Trial
Lexaria's DehydraTECH Semaglutide Shows Superior Tolerability in Phase 1b Trial
Lexaria Bioscience Corp. (LEXX), a global innovator in drug delivery platforms, successfully achieved the primary endpoint in its Phase 1b, 12-week chronic study, GLP-1-H24-4, conducted in Australia. The trial focused on comparing four arms of the company's proprietary DehydraTECH-semaglutide formulation against the control arm, which utilized Rybelsus®, the only currently approved oral GLP-1 medication.
The most significant finding from the study was the marked reduction in adverse events associated with Lexaria’s formulation. DehydraTECH-semaglutide reduced overall side effects by 48% when compared to Rybelsus®. Furthermore, the formulation demonstrated a 55% reduction in gastrointestinal (GI) side effects, a common issue that often limits patient adherence to GLP-1 receptor agonist therapies.
Material Reduction in GI Side Effects Signals Improved Patient Compliance
The reduction in GI side effects is particularly material, as gastrointestinal distress—including nausea, vomiting, and diarrhea—is a well-documented challenge for patients taking oral semaglutide (Rybelsus) and other GLP-1 agonists. Improved tolerability could translate directly into higher patient compliance and better long-term outcomes in the treatment of type 2 diabetes and obesity.
"We are extremely pleased to not only have successfully achieved our primary endpoint," stated Richard Christopher, CEO of Lexaria, "but to have also demonstrated obvious superiority in reducing unwanted side effects by as much as approximately half as compared to the world's only approved oral-based GLP-1 medication, Rybelsus ®."
The successful achievement of the primary endpoint, coupled with the superior side-effect profile, positions Lexaria to potentially capitalize on the rapidly expanding market for GLP-1 treatments. The company noted that recent financings have created a runway for prospective new development opportunities extending into 2026.
Broader Context of the GLP-1 Market
The results arrive amid intense competition and innovation in the GLP-1 sector. While the Lexaria study focuses on tolerability improvements for semaglutide, the broader market is seeing significant advancements, such as the recent FDA approval of Novo Nordisk's Wegovy® pill. This approval, based on the OASIS 4 phase 3 clinical trial, confirmed the efficacy of the once-daily oral semaglutide 25 mg in reducing excess body weight and maintaining weight reduction long term. Wegovy's approval also included an indication for reducing the risk of major adverse cardiovascular events (MACE) in adults with known heart disease and either obesity or overweight.
The success of Novo Nordisk’s oral semaglutide products, including Rybelsus (for type 2 diabetes) and the newly approved oral Wegovy (for weight management), underscores the massive commercial potential of effective oral GLP-1 therapies. Lexaria’s DehydraTECH platform aims to enhance the delivery characteristics of existing drugs, and its application to semaglutide suggests a path toward a more patient-friendly oral formulation that could compete on the basis of reduced adverse events.
Forward Outlook for Lexaria
The Phase 1b study, GLP-1-H24-4, was a 12-week chronic study, providing robust data on long-term tolerability. The final primary and major secondary efficacy endpoint results indicate that Lexaria's drug delivery technology may solve a critical pain point in the oral administration of GLP-1 agonists. The company is expected to leverage these positive results to advance its development program, potentially leading to further clinical trials and partnership opportunities in the coming years, supported by its extended financial runway.
