Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0491-6075 · 1 trial · 2 indications
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...
NNC0491-6075 is an investigational small molecule being studied for use in healthy volunteers and in participants with high levels of fat in the blood, a condition known as dyslipidaemia. It is being developed in the cardiovascular therapeutic area. The drug is currently in Phase 1 clinical development.
NNC0491-6075 is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy people and in participants with dyslipidaemia.
NNC0491-6075 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for safety and tolerability in healthy volunteers and in participants with high levels of fat in the blood.
NNC0491-6075 has one completed Phase 1 clinical trial, registered as NCT05979428. This study evaluated the safety of the drug in healthy people and in participants with high levels of fat in the blood. The trial enrolled 106 participants in the United States and was randomized, double-blind, and controlled.
NNC0491-6075 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed one clinical trial, but it has not yet received regulatory approval for any use. It is being studied for its safety and tolerability in healthy volunteers and in participants with dyslipidaemia.