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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001450-57 | EudraCT Number | ||
| U1111-1266-0594 | Other Identifier | World Health Organization (WHO) |
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Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous).
The study will last for about 65 days including a screening phase of up to 28 days prior to dosing.
If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11).
Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0480-0389 | Experimental | All participants will be administered a single s.c. dose of 18 mg NNC0480-0389 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0480-0389 | Drug | A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin). Total duration of study participation for each participant is 38 to 66 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose | h*nmol/L | From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose | nmol/L | From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36) |
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Inclusion Criteria:
Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive)
Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:
* Current treatment with haemodialysis
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 | 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 |
| D004700 | Endocrine System Diseases |
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