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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1277-3646 | Other Identifier | World Health Organization (WHO) | |
| 2022-001849-20 | EudraCT Number |
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Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with normal renal function | Active Comparator | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
|
| Participants with impaired renal function | Experimental | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose | Measured as hours*nanomoles per litre (h*nmol/L) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose | Measured as nanomoles per litre (nmol/L) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose |
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Inclusion Criteria:
Group description eGFR (mL/min)
Normal renal function greater than or equal to 90
Mild renal impairment 60 - 89
Moderate renal impairment 30 - 59
Severe renal impairment 15 - 29 not requiring dialysis
End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD).
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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Measured in hours (h) |
| From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose | Measured in hours (h) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose | Measured as Litre (L) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose | Measured as Litre per hour (L/h) | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36) |
| CLR,0499,SD: Renal clearance of NNC0194-0499 after a single dose | Measured as Litre per hour (L/h) | From baseline (Visit 2, Day 1, predose) until completion of the urine collection period 96 hours after dosing (Visit 2, Day 5) |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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