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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-7182 | 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 Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment 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 patients 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. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants 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 NNC0480-0389 + 0.5 mg Semaglutide | Experimental | Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
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| Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide) | Placebo Comparator | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
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| 8.6 mg NNC0480-0389 + 0.5 mg Semaglutide | Experimental | Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
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| Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide) | Placebo Comparator | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
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| 30 mg NNC0480-0389 + 0.5 mg Semaglutide | Experimental | Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0480-0389 | Drug | A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of events | From time of dosing (day 1) until completion of the follow-up visit (day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose | Measured in nmol*h/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 upon a single-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (Dept.1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Fukuoka | 812-0025 | Japan |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide) | Placebo Comparator | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
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| Placebo (NNC0480-0389) | Drug | A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days. |
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| Semaglutide | Drug | A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days. |
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| Placebo (Semaglutide) | Drug | A single dose of subcutaneous placebo (semaglutide) 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) |
| AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose | Measured in nmol*h/L | From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |
| Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose | Measured in nmol/L | From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43) |