Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1305-5164 | Other Identifier | Universal Trial Number | |
| 2024-512719-28 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 once weekly (QW) subcutaneously(s.c.). |
|
| Placebo | Placebo Comparator | Participants will receive once weekly s.c. volume-matched placebo to NNC0519-0130. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Measured in number of events. | From time of first dosing (day 1) until completion of the end of study visit (day 274/253) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI) | Measured in milliseconds (ms). | From baseline (day - 1) until completion of the end of study visit (day 274/253) |
| Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF) |
Not provided
Inclusion Criteria:
Participants with obesity only:
Participants with type 2 diabetes with either overweight or obesity:
Exclusion Criteria:
Participants with obesity only:
Participants with type 2 diabetes with either overweight or obesity:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo |
| Drug |
Placebo will be administered subcutaneously. |
|
Measured in ms. |
| From baseline (day - 1) until completion of the end of study visit (day 274/253) |
| Area under the NNC0519-0130 plasma concentration-time curve in steady state | Measured in hours*nanomoles per liter (h*nmol/L). | From pre-dose until 7 days post-dose, for third and last doses in the maintenance period |
| Maximum plasma concentration of NNC0519-0130 in steady state | Measured in nanomoles per liter (nmol/L). | From pre-dose until 7 days post-dose, for third and last doses in the maintenance period |
| 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 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided