Lexaria Secures CRO Contract for 5-Week DHT-sema vs Wegovy Human Study
Lexaria has signed contracts with a CRO to conduct its Human Pilot Study #7 (GLP-1-H26-7), a 5-week, three-arm parallel trial comparing two DehydraTECH-semaglutide formulations to Wegovy tablets under fasted conditions. This study introduces the first DHT-sema tablets and incorporates SNAC in multi-dose formulations to assess safety, tolerability and pharmacokinetics.
1. Study Contracts and Design
Lexaria has finalized contracts with a contract research organization to execute Human Pilot Study #7 (GLP-1-H26-7). The 5-week parallel group trial will enroll three arms evaluating safety, tolerability and pharmacokinetics of two DehydraTECH-semaglutide compositions against commercial Wegovy tablets under fasted pre-dose conditions.
2. Tablet Formulation and SNAC Integration
For the first time, the study includes an oral tablet DHT-sema composition designed to mimic Rybelsus and Wegovy tablet delivery, alongside capsule formulations. Both tablet and capsule test articles are formulated with salcaprozate sodium (SNAC) in a multi-dose, multi-week regimen to achieve steady-state drug concentrations.
3. Trial Timeline and Funding
Study design is virtually complete and ethics approval submissions are underway, with patient recruitment to follow board approval. The fully funded trial leverages existing corporate resources and aims to generate data attractive to pharmaceutical partners for potential commercial licensing of Lexaria’s DehydraTECH technology.