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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1320-4875 | Other Identifier | World Health Organization (WHO) | |
| 2025-521647-20 | Other Identifier | European Medical Agency (EMA) |
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The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. |
|
| Moderate hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. |
|
| Mild hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. |
|
| Normal hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as hours*nanomole per liter (nmol*h/L) | From pre-dose on Day 1 up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose | Measured as nanomoles per liter (nmol/L) | From pre-dose on Day 1 until Day 5 |
| tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Clinical Research s.r.o. | Bratislava | 83101 | Slovakia | |||
| Summit Clinical Research s.r.o. |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Measured as hour
| From pre-dose on Day 1 until Day 5 |
| t½,: Terminal half-life for NNC0487-0111 after a single dose | Measured as hour | From pre-dose on Day 1 up to Day 28 |
| Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose | Liter | From pre-dose on Day 1 up to Day 28 |
| CL/F: Apparent clearance of NNC0487-0111 after a single dose | Measured as liter per hour (L/h) | From pre-dose on Day 1 up to Day 28 |
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events | From pre-dose on Day 1 up to Day 28 |
| Malacky |
| 901 22 |
| Slovakia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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