Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506134-79 | Other Identifier | European Medical Agency (EMA) | |
| U1111-1291-7535 | Other Identifier | World Health Organization (WHO) |
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
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0650-0013: Subcutaneous dose | Experimental | Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo to NNC0650-0013 subcutaneously. |
|
| NNC0650-0013: Intravenous dose | Experimental | Participants will receive NNC0650-0013 in an ascending dose manner intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0650-0013 A | Drug | NNC0650-0013 will be administered subcutaneously or intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| S.C. Cohort: Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From time of dosing (day 1) until completion of the follow-up visit (day 75) |
| Measure | Description | Time Frame |
|---|---|---|
| S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose | Measured as hours nanomoles per liter (h*nmol/L). | From pre-dose (day 1) until completion of the follow up visit (day 75) |
| S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | 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 | Subcutaneous administration. |
|
Measured as nanomoles per liter (nmol/L). |
| From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as h*nmol/L. | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose | Measured as nanomoles per liter (nmol/L). | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose | Measured as h*nmol/L. | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose | Measured as nanomoles per liter (nmol/L). | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as h*nmol/L. | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as h*nmol/L. | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose | Measured as h*nmol/L. | From pre-dose (day 1) until completion of the follow-up visit (day 75) |
| S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered | Measured as hours nanomoles per milligram (h*nmol/mg). | From pre-dose (day1) until completion of the follow-up visit (day 75) |