Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1239-1473 | Other Identifier | World Health Organization (WHO) | |
| 2019-003477-25 | Registry Identifier | European Medicines Agency (EMA) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DV3396 | Experimental | Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product) |
|
| PDS290 | Active Comparator | Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide (administered by DV3396 pen-injector) | Drug | Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period | h*nmol/L | 0-840 hours after one dose of s.c. semaglutide 2 mg |
| Cmax,sema,2mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period | nmol/L | 0-840 hours after one dose of s.c. semaglutide 2 mg |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,sema,2mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period | h*nmol/L | 0-840 hours after one dose of s.c. semaglutide 2 mg |
| tmax,sema,2mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Semaglutide (administered by PDS290 pen-injector) | Drug | Increasing doses of semaglutide given sc in the stomach for 7 weeks |
|
h |
| 0-840 hours after one dose of s.c. semaglutide 2 mg |
| t½,sema,2mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period | h | 0-840 hours after one dose of s.c. semaglutide 2 mg |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |