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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1292-3441 | Other Identifier | Universal Trial Number | |
| 2023-506381-32 | Other Identifier | EU CT Number |
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NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment | Measured in hours* nanomoles per litre (h*nmol/L). | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment | Measured in nanomoles per litre (nmol/L). | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) |
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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 |
|---|---|---|---|---|---|---|
| Charité - Campus Charité Mitte - Charité Research Organisation GmbH | Berlin | 10117 | Germany |
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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| AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure |
Measured in hours* nanomoles per litre (h*nmol/L). |
| From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) |
| Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure | Measured in nanomoles per litre (nmol/L). | From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22) |
| Number of adverse events | Number of events. | From time of dosing (visit 2, day 1) until end of study (visit 9, day 22) |
| D004700 | Endocrine System Diseases |