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This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.
Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.
Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
| |
| E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0070-0002-0349 | Drug | Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG) | Including screening and evaluation: after approx. 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) | 21 days following dosing | |
| Maximum plasma concentration | 21 days following dosing | |
| Time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC 0070-0002-0349 | Drug | Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
|
| NNC 0070-0002-0349 | Drug | Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
|
| NNC 0070-0002-0349 | Drug | Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo) |
|
| NNC 0070-0002-0349 | Drug | Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo) |
|
| placebo | Drug | Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
|
| placebo | Drug | Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
|
| placebo | Drug | Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo |
|
| placebo | Drug | Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection |
|
| placebo | Drug | Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection |
|
| 21 days following dosing |
| Half life | 21 days following dosing |
| 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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