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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1226-5167 | Other Identifier | World Health Organization (WHO) |
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This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment NNC0247-0829 | Experimental | Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment |
|
| Placebo | Placebo Comparator | In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0247-0829 | Drug | Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs) | Number of events | From time of first dosing (Day 1) until Day 71 |
| For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs) | Number of events | From time of first dosing (Day 1) until Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| For SD cohorts: Number of injection site reactions | Number of events | From time of first dosing (Day 1) until Day 71 |
| For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies | Number of events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | 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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First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Placebo (NNC0247-0829) | Drug | Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin. |
|
| From time of first dosing (Day 1) until Day 71 |
| For MD cohorts: Number of injection site reactions | Number of events | From time of first dosing (Day 1) until Day 85 |
| For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies | Number of events | From time of first dosing (Day 1) until Day 85 |
| For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity | nmol/L*h | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |