This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
Celerion, Lincoln
Lincoln, Nebraska, United States
AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in hours\*nanomoles per liter (h\*nmol/L).
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Cmax,cagri,0.25mg/0.25mg,SD: Maximum concentration of cagrilintide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in nanomoles per liter (nmol/L).
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
AUC0-∞,sema,0.25mg/0.25mg,SD: Area under the semaglutide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in h\*nmol/L.
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Cmax,sema,0.25mg/0.25mg,SD: Maximum concentration of semaglutide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in nmol/L.
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Number of adverse events
Measured as number of events.
Time frame: From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)
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