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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1283-0622 | Other Identifier | World Health Organization (WHO) |
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Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner. |
|
| Placebo | Placebo Comparator | Participants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period | 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 after the last dose in each treatment period | Measured in nanomoles per liter (nmol/L). | From pre-dose up to 7 days post-dose |
| t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose |
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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 |
|---|---|---|---|---|---|---|
| Peking University Third Hospital, Northern Branch-Phase I | Beijing | Beijing Municipality | 100089 | China |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo |
| Drug |
Placebo matched to NNC0519-0130 will be administered subcutaneously. |
|
Measured in hours (h). |
| From pre-dose until completion of the follow-up visit (day 162) |
| Number of treatment emergent adverse events (TEAEs) | Measured in number of events. | From time of first dosing (day 1) until completion of the end of study visit (day 162) |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |