Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0581-0001 · 2 trials · 2 indications
Measured as count of events.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: NNC0581-0001 (Dose 1) | EXPERIMENTAL | Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly. |
| Cohort 2: NNC0581-0001 (Dose 2) | EXPERIMENTAL | Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly. |
| Single Dose 1: NNC0581-0001 10 milligram (mg) | EXPERIMENTAL | Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously. |
| Single Dose 2: NNC0581-0001 30 mg | EXPERIMENTAL | Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously. |
| Single Dose 3: NNC0581-0001 90 mg | EXPERIMENTAL | Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously. |
| Single Dose 4: NNC0581-0001 250 mg | EXPERIMENTAL | Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously. |
| Single Dose 5: NNC0581-001 600 mg | EXPERIMENTAL | Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously. |
| Single Dose 6: NNC0581-001 1000 mg | EXPERIMENTAL | Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously. |
| Name | Type | Description |
|---|---|---|
| NNC0581-0001 | DRUG | NNC0581-0001 will be administered subcutaneously. |
| Placebo (NNC0581-0001) | DRUG | Placebo matched to NNC0581-0001 will be administered subcutaneously. |
Inclusion Criteria: * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Male or female (of non-childbearing potential) aged 18...
NNC0581-0001 is an investigational small molecule being developed by Novo Nordisk for the potential treatment of liver diseases, including hepatic steatosis. It is currently in Phase 1 clinical trials studying healthy volunteers, with the goal of evaluating its safety and tolerability as a first step toward treating liver conditions.
NNC0581-0001 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting Phase 1 clinical trials to evaluate this investigational small molecule for potential treatment of liver diseases.
NNC0581-0001 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. Two Phase 1 trials have been conducted or are ongoing, with one completed and one currently recruiting participants.
NNC0581-0001 has been studied in two Phase 1 clinical trials. The first, NCT05599945, was a completed first human dose trial in healthy volunteers and participants with hepatic steatosis in the United Kingdom. The second, NCT06891365, is a recruiting multiple dose study also in the UK, with a total of 96 participants across both trials.
NNC0581-0001 is a small molecule being developed for liver diseases, but its specific molecular target has not been disclosed. The clinical trials are designed to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers, with the goal of understanding how it may potentially treat conditions like hepatic steatosis.