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All three dosing arms have been completed.
The Study is a three-arm, crossover investigation comparing three 7 mg semaglutide dose formulations:
a positive control Rybelsusswallowed tablet;
DehydraTECH-semaglutide swallowed capsules; and
for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
The final DehydraTECH Study arm used a Rybelsus® composition processed with DehydraTECH that is compliant with the
All blood samples collected during the study are now being transported to the bioanalytical lab for analysis. We anticipate completing the analysis and announcing the Study results in late August or early September. Next steps include our evaluation and optimization of different semaglutide formulations in our already-underwayanimal study, as well as evaluation of semaglutide in our upcoming12-week chronic human study.
“Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule,” said
In thepreviously announced human pilot studywith 7 volunteers,
About the Study
Design characteristics of the Study are comparable to Lexaria’s initialhuman pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study is designed to measure tolerability and sideeffects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was fed to the test subjects at a point in time after dosing.Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.
About Semaglutide
Rybelsus® (semaglutide) isthe only GLP-1 drug approved by the FDA for oral dosingto treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®,administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.
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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Phone: 250-765-6424, ext 202
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