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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1219-7303 | Other Identifier | World Health Organization (WHO) |
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The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0174-0833 (0.3 mg) | Experimental | Participants will receive single dose of NNC0174-0833 |
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| NNC0174-0833 (0.9 mg) | Experimental | Participants will receive single dose of NNC0174-0833 |
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| NNC0174-0833 (1.8 mg) | Experimental | Participants will receive single dose of NNC0174-0833 |
|
| Placebo (NNC0174-0833) | Placebo Comparator | Participants will receive placebo (NNC0174-0833) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0174-0833 | Drug | Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose | Measured in h*nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma | Measured in nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Number of treatment emergent adverse events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Glendale | California | 91206 | United States |
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC0174-0833) | Drug | Participants will receive NNC0174-0833 matched placebo subcutaneously. |
|
Count of events
| From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |