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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1274-4577 | Other Identifier | World Health Organization (WHO) | |
| 2022-001359-18 | EudraCT Number |
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This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose 1: NNC0581-0001 10 milligram (mg) | Experimental | Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously. |
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| Single Dose 2: NNC0581-0001 30 mg | Experimental | Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously. |
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| Single Dose 3: NNC0581-0001 90 mg | Experimental | Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously. |
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| Single Dose 4: NNC0581-0001 250 mg | Experimental | Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously. |
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| Single Dose 5: NNC0581-001 600 mg | Experimental | Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0581-0001 | Drug | Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From dosing (Day 1) until completion of the End of Study Visit at week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose | Measured in nanogram hour per mililiter (ng*h/mL). | From dosing (Day 1) to 168 hours after dosing |
| Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose |
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Inclusion Criteria, for healthy participants in Part A:
Inclusion criteria for participants with hepatic steatosis in Part B:
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 |
|---|---|---|---|---|---|---|
| Parexel CPRU, Level 7 | Harrow | Middlesex | HA1 3UJ | United Kingdom | ||
| Parexel Research Unit |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Single Dose 6: NNC0581-001 1000 mg | Experimental | Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously. |
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| Placebo (NNC0581-0001) | Drug | Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001. |
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Measured in nanogram per mililiter (ng/mL). |
| From dosing (Day 1) to 168 hours after dosing |
| tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose | Measured in Hours. | From dosing (Day 1) to 168 hours after dosing |
| Harrow |
| Middlesex |
| HA1 3UJ |
| United Kingdom |