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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1173-8190 | Other Identifier | WHO |
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Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC9204-1177 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC9204-1177 | Drug | A single dose administered subcutaneously ( s.c. under the skin) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From time of dosing (day 1) until completion of the follow-up visit (day 39) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NNC9204-1177 serum concentration-time curve | From 0 to 168 hours after a single s.c. dose | |
| Maximum serum concentration of NNC9204-1177 | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 |
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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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| Placebo |
| Drug |
A single dose administered subcutaneously ( s.c. under the skin) |
|
| From time of dosing (day 1) until completion of the follow-up visit (day 39) |
| Time to maximum serum concentration of NNC9204-1177 | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 | From time of dosing (day 1) until completion of the follow-up visit (day 39) |
| Change in body weight | Day 1, day 39 |
| Change in QT interval corrected using the Fridericia formula (QTcF) | Day 1, day 39 |
| 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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