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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1298-6886 | Other Identifier | World Health Organization (WHO) | |
| 2023-509961-19 | Other Identifier | European Medical Agency (EMA) |
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Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental | Participants with mild renal impairment (estimated glomerular filtration rate [eGFR] - 60 - 89 milliliter per min [mL/min]) will administer a single dose of NNC0487-0111 on Day 1. |
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| Moderate Renal Impairment | Experimental | Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. |
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| Severe Renal Impairment | Experimental | Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1. |
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| End-Stage Renal Disease (ESRD) | Experimental | Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. |
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| Normal Renal Function | Experimental | Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as hours*nanomole per liter (h*nmol/L). | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose | Measured as nanomole per liter (nmol/L). | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose |
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Inclusion Criteria:
Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.
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 Research Organisation GmbH | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Measured as hours. |
| From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose | Measured as hours. | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose | Measured as liter (L) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose | Measured as liter per hour (L/h). | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) |
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28) |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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