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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1326-7700 | Other Identifier | World Health Organisation |
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This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC6989-0001 | Experimental | Participants receive the investigational drug NNC6989-0001 |
|
| Placebo | Placebo Comparator | Participants receive placebo matched in appearance to the active drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC6989-0001 A | Drug | Participants assigned to the active intervention receive NNC6989-0001 A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) - Part A | Measure in number of events. | From time of dosing on Day1 until completion of the end of study visit (Day 7) |
| Number of treatment emergent adverse events (TEAE) - Part B | Measured in number of events | From time of dosing on Day 1 until completion of the end of study visit (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A | Measured in hours times nanograms per millilitre(h*ng/ml). | From pre-dose on Day 1 until completion of the end of study visit (Day 7) |
| Cmax; the maximum plasma concentration of NNC6989-0001 - Part A |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | Recruiting | Lenexa | Kansas | 66219 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC6989-0001 A) | Drug | Participants assigned to the placebo, receive placebo matched in appearance to the active drug. |
|
Measured in nanograms per millilitre(ng/ml). |
| From pre-dose on Day 1 until completion of the end of study visit (Day 7) |
| AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B | Measured in h*ng/ml. | From pre-dose on Day 1 until completion of the end of study visit (Day 14) |
| Cmax; the maximum plasma concentration of NNC6989-0001 - Part B | Measured in ng/ml. | From pre-dose on Day 1 until completion of the end of study visit (Day 14) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |