Lexaria Bioscience announces first results from second GLP-1 human pilot study

Lexaria Bioscience announces that the first results from human pilot study #2, GLP-1-H24-2, 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.” Next steps moving forward in Lexaria’s 2024 GLP-1 experimental program will include finalization of our ongoing animal study, which has already produced positive results as previously announced, and continued progress toward initiation of our planned upcoming 12-week chronic human study, which will be conducted under fasted dosing conditions. Data from the tolerability evaluations and the mouth melt absorption Study arm will also be available soon.