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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1164-6546 | Other Identifier | WHO |
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This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0165-1562 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0165-1562 | Drug | Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs), Part I (SD) | From time of dosing (Day1) until completion of the follow-up visit (Day 29) | |
| Number of TEAEs, Part II (MD) | From time of dosing (Day 1) until completion of the follow-up visit (Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD) | From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29) | |
| The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing. |
|
| From baseline (Day 1) until the follow-up visit (Day 29) |
| The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD) | From baseline (Day 1) until the follow-up visit (Day 29) |
| The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD) | From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85) |
| The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD) | From baseline (Day 1) until the follow-up visit (Day 85) |
| The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD) | From baseline (Day 1) until the follow-up visit (Day 85) |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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