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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-7538 | Other Identifier | World Health Organization (WHO) |
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The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.
The study compares three different doses of the study medicine in Chinese healthy men.
Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.
NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.
We are testing the study medicine to make a medicine that can help people lose weight.
Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.
The study will last for about 5 months. But participants participation will last about 2 months.
Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.
At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.
Participants will be asked about their health, medical history and habits including mental health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0174 0833 1.8 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 |
|
| NNC0174 0833 0.9 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 |
|
| NNC0174 0833 0.3 mg | Experimental | Each participant will receive one single dose of NNC0174 0833 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0174 0833 | Drug | Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose | measured in h·nmol/L | From pre-dose (Day 1) to Visit 7 (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose | measured in h·nmol/L | From pre-dose (Day 1) to Visit 3 (Day 8) |
| Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma |
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Key inclusion criteria
Key exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200031 | China |
"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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measured in nmol/L |
| From pre-dose (Day 1) to Visit 7 (Day 36) |
| tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833 | measured in hours | From pre-dose (Day 1) to Visit 7 (Day 36) |
| t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833 | measured in hours | From pre-dose (Day 1) to Visit 7 (Day 36) |
| CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833 | measured in L/h | From pre-dose (Day 1) to Visit 7 (Day 36) |
| Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase | measured in L | From pre-dose (Day 1) to Visit 7 (Day 36) |
| Change in body weight | measured in percentage | From pre-dose (Day 1) to Visit 7 (Day 36) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |