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 developed by Novo Nordisk A/S for hepatic steatosis, a condition involving fat accumulation in the liver. It is in Phase 1 clinical development and has been studied in two trials totaling 96 participants. It is not yet approved for any indication.
NNC0581-0001 is being developed to potentially treat hepatic steatosis, also known as fatty liver. The clinical program has enrolled healthy volunteers and participants with hepatic steatosis in the United Kingdom. Because it remains in Phase 1 testing, its safety and activity in patients are still being evaluated.
NNC0581-0001 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is running the Phase 1 program for this small molecule candidate in hepatic steatosis, with trials conducted in the United Kingdom.
NNC0581-0001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulator. Two Phase 1 trials have been conducted, one completed and one currently recruiting, with a combined enrollment of 96 participants.
NNC0581-0001 has been studied in two Phase 1 trials. NCT05599945 was a completed first human dose trial in healthy volunteers and hepatic steatosis. NCT06891365 is an ongoing multiple dose study in healthy volunteers and hepatic steatosis that is currently recruiting in the United Kingdom.
The NNC0581-0001 trials are randomized, double-blind, and controlled, with 48 participants enrolled in each study. NCT05599945, the completed first human dose trial, enrolled healthy volunteers. NCT06891365, the recruiting multiple dose study, includes healthy volunteers and participants with hepatic steatosis in the United Kingdom.