Lexaria Completes Manufacturing for Oral DHT-Semaglutide Study, Ethics Approval Submitted
Lexaria has completed commercial-scale manufacturing and QC testing for two oral DehydraTECH-semaglutide compositions and submitted ethics approval requests for its five-week, three-arm comparative study versus Wegovy tablets. Human Study #7 is designed to assess safety, tolerability and pharmacokinetics under fasted conditions, with dosing expected mid-June.
1. Ethics Approval and Test Article Preparation
Lexaria has submitted formal ethics approval requests to an independent review board and finalized laboratory tablet composition work. Commercial-scale manufacturing of the DHT-sema tablet and capsule test articles is complete, and third-party QC testing and packaging are expected to finish by early June.
2. Comparative Study Design
Human Study #7 is a five-week, three-arm, parallel-group trial under fasted conditions. It will compare a SNAC-inclusive DehydraTECH-semaglutide tablet and capsule formulation against Wegovy tablets, focusing on safety, tolerability and pharmacokinetic performance.
3. Path to Commercialization
Dosing is anticipated to begin in mid-June, fully funded from existing resources. Lexaria aims to leverage study results to secure pharmaceutical partnerships and validate its DehydraTECH enhancements in tablet delivery and multi-week SNAC formulation.