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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1151-0761 | Registry Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC9204-0530 | Drug | Administered as single subcutaneous (s.c., under the skin) injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events recorded | From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NNC9204-0530 serum concentration-time curve | From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points | |
| Maximum concentration of NNC9204-0530 in serum | From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| liraglutide | Drug | Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg. |
|
| placebo | Drug | Administered as single subcutaneous (s.c., under the skin) injections. |
|
| The time to maximum concentration of NNC9204-0530 in serum | From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points |
| The terminal half-life of NNC9204-0530 | From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points |
| 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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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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