Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0582-0001 · 1 trial · 1 indication
Measured as number of events.
| Arm | Type | Description |
|---|---|---|
| Single Dose 1: NNC0582-0001 10 milligram (mg) | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously. |
| Single Dose 2: NNC0582-0001 30 mg | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously. |
| Single Dose 3: NNC0582-0001 90 mg | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously. |
| Single Dose 4: NNC0582-0001 250 mg | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously. |
| Single Dose 5: NNC0582-0001 600 mg | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously. |
| Single Dose 6: NNC0582-0001 1000 mg | EXPERIMENTAL | Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously. |
| Name | Type | Description |
|---|---|---|
| NNC0582-0001 | DRUG | Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts. |
| Placebo | DRUG | Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001. |
Inclusion Criteria: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * Considered to be generally healthy based on th...
NNC0582-0001 is an investigational small molecule drug developed by Novo Nordisk A/S. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to assess its safety, tolerability, how it is transported throughout the body, and how it works. The specific disease or condition it is intended to treat has not been disclosed.
NNC0582-0001 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. Novo Nordisk is the sponsor of the clinical trial evaluating this compound.
NNC0582-0001 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy volunteers. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for any indication.
NNC0582-0001 has been evaluated in one completed Phase 1 clinical trial, NCT05624580, titled "A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults." The trial enrolled 56 healthy adult volunteers in Austria and was randomized, double-blind, and controlled.
No, NNC0582-0001 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development. The only completed trial was a Phase 1 study in healthy volunteers, and no regulatory approval has been granted for any indication.