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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1177-7821 | Other Identifier | World Health Organization (WHO) |
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This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC9204-1706 A | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC9204-1706 A | Drug | Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | Count and % of events | From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NNC9204-1706 plasma concentration-time curve | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Area under the NNC9204-1706 plasma concentration-time curve (0-24h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21225 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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| Placebo | Drug | Administered subcutaneously (s.c., under the skin) |
|
Calculated based on NNC9204-1706 measured in blood.
| Day 1- Day 7 |
| Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample) | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Maximal observed concentration of the NNC9204-1706 plasma concentration curve | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Time to observed maximum concentration of NNC9204-1706 in plasma | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Terminal half-life of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Mean residence time of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| The apparent total plasma clearance of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| The apparent volume of distribution of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 |
| Changes in Body weight | Measured in kg and/or % | Day 1, Days 10-13 |
| Number of injection-site reactions | Count of reactions | From the time of dosing (Day 1) to the follow-up visit (Days 10-13) |
| Number of hypoglycaemic episodes | Count of episodes | from time of dosing (Day 1) to the follow-up visit (Days 10-13) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |