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First Results from Lexaria's Second GLP-1 Human Pilot Study
Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH®-processed Rybelsus® KELOWNA, BC / ACCESSWIRE / August 27, 2024 /
About this update from Lexaria Bioscience Corp.
[{"type":"text","content":"Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH®-processed Rybelsus® KELOWNA, BC / ACCESSWIRE / August 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the \"Company\" or \"Lexaria\"), a global innovator in drug delivery platforms announces that the first results from human pilot study #2, GLP-1-H24-2 (the \"Study\"), have been received. Lexaria's DehydraTECH®-processed Rybelsus® evidenced a trend toward higher overall absorption compared to Rybelsus® that was not processed with DehydraTECH.Since Lexaria has already demonstrated superior pharmacokinetic performance of its DehydraTECH-processed Rybelsus® under the recommended dosing conditions on an empty stomach in previously announced human pilot study #1, GLP-1-H24-1, it was deemed to be of scientific interest to learn whether the DehydraTECH advantages were also experienced under fed conditions. The DehydraTECH-processed Rybelsus® evidenced higher semaglutide levels in 17 of the 19 blood draws taken until the 24-hour completion of the study averaging 18.8% higher semaglutide levels over the course of the study compared to Rybelsus® alone, although the differences were variable and not significant statistically with such a small sample size.The two arms of the Study being reported today compared equal 7 mg semaglutide doses from a Rybelsus® swallowed tablet versus a DehydraTECH-processed Rybelsus® swallowed capsule. The volunteers in this Study were administered the drugs while they were in a \"fed\" state, as compared to an earlier study that demonstrated a 43% peak blood level improvement wherein the volunteers were administered the drug in a \"fasted\" state. It should be noted that Novo Nordisk™, the owner and manufacturer of Rybelsus®, recommends taking Rybelsus® on an empty stomach, because studies have shown that Rybelsus administration under fed conditions leads to decreased systemic absorption. Their label reads, \"Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces).\"Semaglutide Absorption (nmol/l)Time (minutes)Rybelsus®DehydraTECH Rybelsus®Difference (%)00.000.00N/A200.000.48N/A400.361.06196.9%601.241.6331.3%801.702.1224.8%1002.542.602.2%1203.133.12-0.4%1403.503.808.6%1603.864.137.2%1804.274.495.2%2104.644.987.2%2405.025.478.8%3005.646.2310.4%3606....