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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1309-7476 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | Participants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
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| Treatment sequence 2 | Experimental | Participants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CagriSema (cagrilintide B and semaglutide I) | Drug | Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. | 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. | From 0 hours (pre-dose) to 1176 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Measured as number of events. | From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99) |
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Inclusion criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Lincoln | Lincoln | Nebraska | 68502 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| CagriSema A | Drug | Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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