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First-ever DehydraTECH-processed tirzepatide from Zepbound® to be tested in a swallowed oral format
The Study will be a randomized, crossover investigation that will compare injected tirzepatide (Zepbound® by Eli Lilly) to a compound formulated, DehydraTECH-processed tirzepatide derived from Zepbound® and rendered into a capsule to be swallowed. There are two study arms:
DehydraTECH-tirzepatide swallowed capsules; and,
Injected Zepbound® tirzepatide by Eli Lilly.
Tirzepatide is currently available only in its injected form, Zepbound®, by Eli Lilly – it is not available in an FDA-approved oral dosage format. The Study will evaluate whether DehydraTECH-processed tirzepatide, when taken orally, offers any absorption into the human bloodstream and, if so, how much. Human tolerability, pharmacokinetics and blood sugar levels will all be recorded and evaluated in this Study.
“Many GLP-1 drugs have produced unpleasant side effects, especially when dosed through oral tablets,” said
Manufacturing of the test articles for this Study is anticipated to be completed within 30 days.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria’s initial GLP-1human pilot study. The DehydraTECH-tirzepatide test articles will be compound formulated using Zepbound®, strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing.Eight healthy subjects are expected to be dosed with each test article following a cross over study design across two study visits.
About
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016,
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Copyright (c) 2024 TheNewswire - All rights reserved., source