Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05979428 | A Study to Look at How Safe a New Medicine (NNC0491-6075) is in Healthy People and in Participants With High Levels of Fat in the Blood | PHASE1 | COMPLETED | 106 | — | — | Aug 7, 2023 | Mar 14, 2025 | May 4, 2025 | 1 | United States |
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: Part A: * Men or women of non-childbearing potential * Aged 18-55 years (both inclusive) at the time of signing informed consent * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinic...