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Lexaria's DehydraTECH-Liraglutide Human GLP-1 Clinical Study Supports Pathway to Potential FDA Registration as an Orally-Delivered Capsule
Thenewswire· 2025-06-11 13:05
Core Insights - Lexaria Bioscience Corp. has successfully completed a human study comparing oral DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide, with partial results now available [1][8] - The study demonstrated a 22.7% reduction in adverse events (AEs) for oral DehydraTECH-liraglutide compared to Saxenda®, with significant reductions in nausea (67%) and gastrointestinal AEs (31%) [3][4] - Lexaria is seeking a pharmaceutical partner to develop an FDA-registered oral alternative to current injectable GLP-1 drugs, addressing an unmet market need [2][10] Study Details - The study involved 10 overweight volunteers, comparing daily doses of Saxenda® (0.6 mg) and DehydraTECH-liraglutide (45 mg) over a 7-day period [13] - The primary endpoint was the evaluation of safety and tolerability, with secondary objectives including pharmacokinetics and effects on body weight, blood glucose, and insulin levels [16] - Weight loss was observed in 9 out of 10 participants in both study arms, although it was not the primary goal of the study [5] Technology and Market Context - DehydraTECH is a patented drug delivery technology that enhances bio-absorption and reduces side effects, with 48 patents granted and more pending [17] - The study's results suggest that DehydraTECH-liraglutide could provide a viable oral alternative to Saxenda® and other injectable liraglutide products, which generated significant revenue for Novo Nordisk [12] - Lexaria's approach may allow for an expedited FDA regulatory pathway under the 505(b)(2) application, contingent on demonstrating comparable performance to existing injectable versions [6][10]