Completed
PHASE1
INTERVENTIONAL
NCT06716307
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
CagriSema (cagrilintide B and semaglutide I)
Type:
DRUG
Description:
Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
Name:
CagriSema A
Type:
DRUG
Description:
Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
Primary Outcomes
Measure:
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
TimeFrame:
From 0 hours (pre-dose) to 1176 hours (post-dose)
Description:
Measured in hours\*nanomoles per liter (h\*nmol/L).
Measure:
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
TimeFrame:
From 0 hours (pre-dose) to 1176 hours (post-dose)
Description:
Measured in nanomoles per liter (nmol/L).
Measure:
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
TimeFrame:
From 0 hours (pre-dose) to 1176 hours (post-dose)
Description:
Measured in h\*nmol/L.
Measure:
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
TimeFrame:
From 0 hours (pre-dose) to 1176 hours (post-dose)
Description:
Measured in nmol/L.
Trial Information
NCT ID
NCT06716307
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025