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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-4516 | Other Identifier | World Health Organization (WHO) |
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This study looks at how the new medicine called NNC0480-0389 works in the body of Chinese men when it is given at different doses together with a fixed dose of semaglutide. Participants will get one injection of NNC0480-0389 and one injection of semaglutide - which dose of NNC0480-0389 participants get is decided by chance.
NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities.
Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes.
NNC0480-0389 is being developed to be given together with semaglutide. NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood in people with type 2 diabetes.
Participants will get 2 injections of the study medicine (one of each). It will be injected with a needle into a skin fold on participants abdomen.
The study will last for a maximum of 72 days. Partcicipants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.7 mg NNC0408-0389 plus 0.5 mg semaglutide | Experimental | Participants will receive a single subcutanous dose of 1.7 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
|
| 8.6 mg NNC0480-0389 plus 0.5 mg semaglutide | Experimental | Participants will receive a single subcutanous dose of 8.6 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
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| 30 mg NNC0480 0389 plus 0.5 mg semaglutide | Experimental | Participants will receive a single subcutanous dose of 30 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0480 0389 | Drug | Participants will get 1 injections of NNC04800389. It will be injected with a needle into a skin fold on the abdomen. The study will last for a maximum of 72 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,NNC0480-0389,SD Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity after a single dose (SD) | measured in hnmol^L | From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |
| Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after a single dose | measured in nmol/L | From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose | measured in hnmol^L | From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |
| Cmax,sema,SD The maximum plasma concentration of semaglutide after a single dose |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100730 | China |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Semaglutide | Drug | Participants will get 1 injections of semaglutide. It will be injected with a needle into a skin fold on the abdomen. The study will last for a maximum of 72 days |
|
measured in nmol^L |
| From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |
| D004700 | Endocrine System Diseases |