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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1315-2937 | Other Identifier | World Health Organization (WHO) |
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The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0662-0419 (Dose 1) | Experimental | Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously. |
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| NNC0662-0419 (Dose 2) | Experimental | Participants will receive a SD of NNC0662-0419 subcutaneously. |
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| NNC0662-0419 (Dose 3) | Experimental | Participants will receive a SD of NNC0662-0419 subcutaneously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0662-0419 | Drug | Participants will receive NNC0662-0419 subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC; The area under the NNC0662-0419 plasma concentration-time curve | Measured in hours*nanomoles per liter (h*nmol/L). | From pre-dose on Day 1 until completion of the end of study visit (Day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax; The maximum plasma concentration of NNC0662-0419 | Measured in nanomoles per liter (nmol/L). | From pre-dose on Day 1 until completion of the end of study visit (Day 29) |
| Number of treatment-emergent adverse events (TEAEs) |
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Inclusion Criteria:
Male or female (sex at birth) Japanese, Chinese or non-Asian participants (all self-reported).
Age 18-55 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical LA, Inc. | Cypress | California | 90630 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Measured as number of events.
| From time of dosing on Day 1 until completion of the end of study visit (Day 29) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |