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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1307-3788 | Other Identifier | World Health Organization (WHO) |
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This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: NNC0519-0130 C and NNC0519-0130 B | Experimental | Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C. |
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| Part 1b: NNC0519-0130 B and NNC0519-0130 C | Experimental | Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C. |
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| Part 2a: NNC0519-0130 B and NNC0519-0130 C | Experimental | Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C. |
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| Part 2b: NNC0519-0130 C and NNC0519-0130 B | Experimental | Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 B | Drug | NNC0519-0130 B will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS) | Measured in hours*nanomoles per liter (h*nmol/L). | From pre-dose up to 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state | Measured in nanomoles per liter (nmol/L). | From pre-dose up to 7 days post-dose |
| Number of adverse events | Measured in number of events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | San Antonio | Texas | 78209 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| NNC0519-0130 C | Drug | NNC0519-0130 C will be administered subcutaneously. |
|
| From time of first dosing (day 1) until completion of the end of study visit (day 141/162) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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