Lexaria's DehydraTECH-Semaglutide Shows 48% Reduction in Side Effects Compared to Rybelsus in Phase 1b Trial

Lexaria Bioscience查看公司主页 Corporation has announced positive results from its Phase 1b study GLP-1 (搜索)搜索该靶点-H24-4, demonstrating that its DehydraTECH-semaglutide查看药品详情 formulation significantly reduces side effects compared to the approved oral GLP-1 medication Rybelsus查看药品详情. The 12-week chronic study met its primary safety endpoint, showing a 47.9% reduction in total adverse events and a statistically significant 54.9% reduction in gastrointestinal adverse events.

Study Design and Patient Population

The Phase 1b study GLP-1 (搜索)搜索该靶点-H24-4 investigated 126 overweight, obese, pre-diabetic and/or type-2 diabetic volunteers across five treatment arms. The study included three initial DehydraTECH arms testing DehydraTECH-CBD, DehydraTECH-semaglutide查看药品详情, and a combination of DehydraTECH-CBD with DehydraTECH-semaglutide, plus a later-added DHT-tirzepatide查看药品详情 arm. Performance across these four DehydraTECH study arms was compared with commercially available Rybelsus查看药品详情, the only approved oral GLP-1 medication, serving as the study's positive control group.

Each study arm enrolled 24-25 patients, with the primary endpoint focused on assessing safety and tolerability based on the incidence of treatment-emergent adverse events. The study was conducted in Australia and completed with the last patient visit in August 2025.

Primary Safety Results

The study achieved its primary endpoint, indicating that all four DehydraTECH test articles appeared safe and well-tolerated. The data showed a 47.9% reduction in the total number of adverse events with DHT-semaglutide查看药品详情 compared with Rybelsus查看药品详情. Additionally, a statistically significant 54.9% reduction in gastrointestinal adverse events with DHT-semaglutide compared with Rybelsus was observed.

Notably, DHT-semaglutide查看药品详情 adverse event percentage reductions were higher at the end of the study than at the 8-week interim analysis, suggesting improved tolerability over time. The study documented at least one adverse event for each of the 25 subjects in the Rybelsus查看药品详情 arm, while five subjects in the DHT arm experienced no adverse events.

Secondary Efficacy Endpoints

The major secondary efficacy endpoints included assessments of glycated hemoglobin (HbA1c) and body weight changes. At week 16, rough parity was reached between the DehydraTECH arms and the Rybelsus查看药品详情 control, with no statistically significant treatment differences observed in terms of the numerical least squares means changes from baseline in secondary efficacy parameters including mean fasting glucose, cholesterol, and low density lipoprotein cholesterol.

DHT-semaglutide查看药品详情 showed modest reductions in HbA1c that were not statistically different from those of Rybelsus查看药品详情. Body weight reduction performance was improved for the Rybelsus control arm compared to all DehydraTECH arms at both the week 12 and week 16 evaluations, which remains consistent with the previously reported 8-week interim analysis.

Body Composition Analysis

A separate body composition analysis performed using dual-energy X-ray absorptiometry and Bioelectrical Impedance Analysis methodology revealed intriguing differences between treatment arms. At week 12, the DHT-semaglutide查看药品详情 arm showed a modest numerical least squares mean reduction in fat mass of -1.08 kg and in total mass of -1.40 kg, accompanied by minimal reduction in lean mass of -0.41 kg.

In contrast, the Rybelsus查看药品详情 control arm achieved greater least squares mean reductions in fat mass of -3.55 kg and in total mass of -5.36 kg, but also had a notably higher reduction in lean mass of -1.72 kg. This finding is considered intriguing as it possibly points to proportionally lower lean mass to fat mass bodyweight reduction potential being achievable with DHT-semaglutide查看药品详情.

Blood Pressure Findings

While blood pressure analysis was not formally an efficacy endpoint of the study, the DHT-cannabidiol查看药品详情 arm achieved meaningful reductions in blood pressure, which is of special interest since the study participants were not generally hypertensive. At week 4, a mean change of -4.6 mmHg in systolic blood pressure and -4.0 mmHg in diastolic blood pressure was evidenced in the DHT-CBD arm. Blood pressure reductions were also evident in this arm following completion of treatment at the week 16 follow-up point with a mean change of -2.6 mmHg in systolic blood pressure and -3.0 mmHg in diastolic blood pressure reported.

Partnership and Future Development

Lexaria will provide the dataset to the pharmaceutical company with which it has a Material Transfer Agreement, which was recently extended to April 30, 2026, to accommodate the time required for the partner's receipt and current dataset review. The company highlighted the chemistry of salcaprozate sodium (SNAC) in its DHT-semaglutide查看药品详情 formulations, which were initially tested in previous human clinical studies GLP-1 (搜索)搜索该靶点-H24-1 and GLP-1-H24-2, but were not included in the current study.

Moving forward, Lexaria intends to consider options for prospective follow-on human clinical testing of a DehydraTECH + SNAC + semaglutide查看药品详情 composition compared to Rybelsus查看药品详情, to expand and build upon the learnings from human studies GLP-1 (搜索)搜索该靶点-H24-1, GLP-1-H24-2, and the current GLP-1-H24-4.

Financial Position

Lexaria reported that financings totaling approximately $7.5 million across two transactions since August 31 have created a runway for prospective new 2026 development opportunities. The company reported annual revenues of $706,000 and total operating expenses of $11.9 million for fiscal year 2025, resulting in a net loss of $11.9 million. Research and development expenses totaled $8.2 million, up 249% from the prior year due to spending on the commencement and completion of the Phase 1b study.