The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
Increasing doses of semaglutide given sc in the stomach for 21 weeks
Novo Nordisk Investigational Site
Mainz, Germany
Novo Nordisk Investigational Site
Neuss, Germany
AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg
h\*nmol/L
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg
nmol/L
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
AUC0-168h,1mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 1 mg
h\*nmol/L
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg
nmol/L
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Tmax,2.4mg,SS: Time of maximum observed semaglutide concentration after last 2.4 mg dose
h
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Tmax,1mg,SS: Time of maximum observed semaglutide concentration after last 1 mg dose
h
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
t½: Terminal elimination half-life of semaglutide after last 2.4 mg dose
h
Time frame: 0-1176 hours (Day 141-190) after last 2.4 mg dose
Cl/F2.4mg: Total apparent clearance of semaglutide after last 2.4 mg dose
L/h
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Cl/F1mg: Total apparent clearance of semaglutide after last 1 mg dose
L/h
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Vss/F2.4mg: Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
L
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Vss/F1mg: Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
L
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Change in body weight
percent
Time frame: From baseline (Day 1, pre-dose) until the end of treatment (Day 148)
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