Obesity
Conditions
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
Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
DRUGCagriSema A
Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female. * Aged 18-64 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. \- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous dosing with an amylin analogue. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * Glycosylated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From 0 hours (pre-dose) to 1176 hours (post-dose) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| 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 | From 0 hours (pre-dose) to 1176 hours (post-dose) | Measured in nanomoles per liter (nmol/L). |
| 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 | From 0 hours (pre-dose) to 1176 hours (post-dose) | Measured in h\*nmol/L. |
| 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 | From 0 hours (pre-dose) to 1176 hours (post-dose) | Measured in nmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99) | Measured as number of events. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed