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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-1575 | Other Identifier | World Health Organization (WHO) |
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The study is testing a new study medicine to treat people with high levels of fat in the blood. The main aim of the study is to see if the new study medicine is safe and how it works in the body. Participants will either get NNC0491-6075 (the new study medicine) or placebo (a "dummy medicine" without active ingredients). Which treatment participants get is decided by chance. NNC0491-6075 is a new medicine which cannot be prescribed by doctors. The study has 3 parts (Part A, Part B and Part C). In Part A, investigators look at the effect of the study medicine after a single dose in healthy participants. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. In Part B, investigators look at the effect of receiving the study medicine once weekly for four weeks in participants with high levels of fat in the blood but who are otherwise healthy. Participants will get the study medicine as injections under the skin by the study staff. In Part C, investigators look at the effect of the study medicine after a single dose in healthy participants of Japanese origin. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. The study will last for about 18 months in total for Part A, Part B and Part C. Participants in Part A and Part C will be in the study for about 139 days each, from screening to the final visit while in Part B they will be in the study for about 160 days from screening to the final visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Single ascending dose (SAD) cohorts in healthy participants: | Experimental | Healthy participants, randomized in 3:1 ratio in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 5 cohorts (Cohort A1, A2, A3, A4 and A5). In cohorts A1, A2 and A3, the participants will receive subcutaneous injection, whereas in cohorts A4 and A5 the administration will be performed intravenously. |
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| Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants | Experimental | Participants with dyslipidemia, randomized in the ratio 2:1 in each of the cohorts will receive multiple ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort B1,B2 and B3). Participants will receive subcutaneous injections of either NNC0491-6075 or placebo once weekly for 4 weeks. |
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| Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants: | Experimental | Healthy Japanese participants, randomized in the ratio 3:1 in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort C1,C2 and C3). The route of administration will be subcutaneous or intravenous. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0491-6075 | Drug | NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): Number of treatment emergent adverse events (TEAEs) | Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit. | From pre-dose (Day 1) to end of study (Day 110) |
| Part B (MAD): Number of treatment emergent adverse events (TEAEs) | Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit. | From pre-dose (Day 1) to end of study (Day 131) |
| Part C (SAD): Number of treatment emergent adverse events (TEAEs) | Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit. | From pre-dose (Day 1) to end of study (Day 110) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose | Measured as hours*nanomoles per liter (h*nmol/L) | From pre-dose (Day 1) to end of study (Day 110) |
| Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose |
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Inclusion Criteria:
Part A:
Part B:
Part C:
Exclusion Criteria:
Part A,B and C:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical LA, Inc. | Cypress | California | 90630 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Placebo matched to NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand. |
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Measured as nanomoles per liter (nmol/L) |
| From pre-dose (Day 1) to end of study (Day 110) |
| Part A (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose | Measured as hours (h) | From pre-dose (Day 1) to end of study (Day 110) |
| Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration) | Measured as hours | From pre-dose (Day 1) to end of study (Day 110) |
| Part B (MAD): AUC0-168h, MD; the area under the NNC0491-6075 serum concentration-time curve from time 0 to 168 hours after last dose | Measured as h*nmol/L | From pre-dose (Day 22) to 168 hours after last dose (Day 29) |
| Part B (MAD): Cmax, MD; the maximum serum concentration of NNC0491-6075 after last dose | Measured as nmol/L | From pre-dose (Day 22) to end of study (Day 131) |
| Part B (MAD): t½, MD; the terminal half-life of NNC0491-6075 after last dose | Measured as hours | From pre-dose (Day 22) to end of study (Day 131) |
| Part B (MAD): tmax, MD; The time to maximum concentration of NNC0491-6075 after last dose | Measured as hours | From pre-dose (Day 22) to end of study (Day 131) |
| Part C (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose | Measured as h*nmol/L | From pre-dose (Day 1) to end of study (Day 110) |
| Part C (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose | Measured as nmol/L | From pre-dose (Day 1) to end of study (Day 110) |
| Part C (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose | Measured as hours | From pre-dose (Day 1) to end of study (Day 110) |
| Part C (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration) | Measured as hours | From pre-dose (Day 1) to end of study (Day 110) |