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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-1002 | Other Identifier | World Health Organization (WHO) | |
| 2023-505026-34 | Registry Identifier | European Medical Agency (EMA) |
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The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.
The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.
Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
The study will last for about 10 months in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC6022-0001 | Experimental | Participants will be randomised to NNC6022-0001. |
|
| Placebo (NNC6022-0001) | Placebo Comparator | Participants will be randomised to placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC6022-0001 | Drug | Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) | Number of events | From time of dosing (Day 1) to end of study (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose | Hours*micrometer (hr×µM) | From pre-dose (Day 1) to end of exposure (Day 7) |
| AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention(s) or similar products.
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.
Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.
Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (Dept. 2834). | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - location Groningen | Groningen | 9728 NZ | Netherlands |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC6022-0001) | Drug | Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts |
|
Hours*micrometer (hr×µM) |
| From pre-dose (Day 1) to end of exposure (Day 7) |
| Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose | Micrometer (µM) | From pre-dose (Day 1) to end of exposure (Day 7) |
| IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline | Percentage (%) | From pre-dose (Day 1) to estimated tmax (Day 1) |