The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in. The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks. The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
546
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Altasciences Clinical LA, Inc.
Cypress, California, United States
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Altasciences Company Inc.
Montreal, Quebec, Canada
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
h∙nmol/L
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
nmol/L
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state
h
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state
nmol/L
Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
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