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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1328-9401 | Other Identifier | World Health Organization (WHO) |
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The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously. |
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| Cohort 2 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously. |
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| Cohort 3 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously. |
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| Cohort 4 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously. |
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| Cohort 5 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously. |
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| Cohort 6 NNC0113-5840 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-5840 | Drug | NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From time of dosing (day 1) up to day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC: Area under the NNC0113-5840 plasma concentration time-curve | Measured as hours*nanomole per liter (h*nmol/L) | From pre-dose (day 1) up to day 43 |
| Cmax: Maximum observed NNC0113-5840 plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Glendale/LA EPCU | Recruiting | Glendale | California | 91206 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.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 randomized to receive NNC0113-5840 single dose level 6 subcutaneously. |
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| Placebo matching NNC0113-5840 | Placebo Comparator | Participants will receive placebo matched to NNC0113-5840 subcutaneously. |
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| Placebo | Drug | Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin. |
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Measured as nanomoles per liter (nmol/L)
| From pre-dose (day 1) up to day 43 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |