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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1298-9340 | Other Identifier | World Health Organization (WHO) | |
| 2023-508940-23 | Other Identifier | European Medical Agency (EMA) |
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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 people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: NNC0519-0130 | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase. |
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| Arm 2: NNC0519-0130 | Experimental | Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase. |
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| Arm 3: NNC0519-0130 | Experimental | Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase. |
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| Arm 4: NNC0519-0130 | Experimental | Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Measured as number of events. | From randomisation (week 0) to week 18 |
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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 |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8010 | Austria |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |