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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004856-41 | EudraCT Number | ||
| U1111-1267-4254 | Other Identifier | World Health Organization (WHO) |
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NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reducing overweight which is often present in participants with type 2 diabetes. In this study NNC0519-0130 is given to humans for the first time. This study will be looking into how safe the new medicine NNC0519-0130 is and will measure its concentrations in the blood. Moreover, effects on blood sugar, blood fat and body weight will be tested. There are different study parts with different participants. Healthy participants (men), healthy participants (men) with high body weight and people with diabetes (men and women) take part. Single doses and multiple doses are tested and the medicine is studied as an injection or when given orally (as a tablet). The participants are invited to take part in a part of the study which will look at the effects of weekly injected doses of NNC0519-0130 taken over the course of several weeks. It is planned that participants will be given the study medicine once weekly. The dose will be increased every three weeks, if safety and tolerability allow. Participants will take up to six different dose levels. This means that the period with weekly injections of study medicine will in total last up to 18 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Which medicine participant gets is decided by chance. The injection of study medicine will be done by trained staff into the tissue underneath the skin of belly using a syringe and needle. The total duration of the study could last up to 25 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose (SAD) part | Experimental | Participants will receive up to six dose levels of subcutaneous NNC0519-0130 or matching placebo in a sequential manner with the dose increasing between cohorts. |
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| Multiple ascending dose (MAD) QD part | Experimental | MAD QD part comprises two cohorts in participants with overweight or obesity and a cohort in participants with type 2 diabetes (T2D). The participants in first cohort will receive NNC0519-0130 or matching placebo subcutaneously up to 5 dose levels, and the participants in the second MAD QD cohort will receive NNC0519-0130 or matching placebo orally up to 5 dose levels. |
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| Type 2 diabetes (T2D) part | Experimental | Participants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort. |
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| MAD QW part | Experimental | MAD QW part comprises two cohorts in participants with overweight or obesity and who are otherwise generally healthy. The participants in first cohort will receive NNC0519-0130 and 2nd cohort will receive matching placebo subcutaneously up to 6 dose levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | SAD part: Participants will receive up to six dose levels of subcutaneous NNC0519-0130 in a sequential manner with the dose increasing between cohorts. MAD part: The participants in first cohort will receive NNC0519-0130 subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive NNC0519-0130 up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive NNC0519-0130 up to 6 dose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part | Measured as Number of events | From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days) |
| Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort | Measured as Number of events | From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) |
| Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort | Measured as Number of events | From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) |
| Number of treatment emergent adverse events (TEAE) in T2D QW cohort | Measured as number of events | From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose | Measured in h*nmol/L | From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days) |
| Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Søborg | 2860 | Denmark | |||
| Profil GmbH & Co. KG |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Placebo (NNC0519-0130) | Drug | SAD part: Participants will receive up to six dose levels of subcutaneous placebo (NNC0519-0130) in a sequential manner with the dose increasing between cohorts. MAD part: Participants in first cohort will receive placebo (NNC0519-0130) subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive placebo (NNC0519-0130) up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive Placebo up to 6 dose levels. |
|
Measure in nmol/L |
| From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days) |
| Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort | Measured as Number of events | From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days) |
| AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part | Measured in h*nmol/L | From pre-dose (last dose in each treatment period) until 24 hours post-dose |
| Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part | Measured in nmol/L | From pre-dose (last dose in each treatment period) until 24 hours postdose |
| AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort | Measured in h*nmol/L | From pre-dose (last dose) until 168 hours post-dose |
| Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort | Measured in nmol/L | From pre-dose (last dose) until 168 hours post-dose |
| AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort | measured in h*nmol/L | From pre-dose (last dose in each treatment period) until 168 hours post-dose |
| Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort | Measured in nmol/L | From pre-dose (last dose in each treatment period) until 168 hours post-dose |
| Mainz |
| 55116 |
| Germany |
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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