Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0537-1482 · 3 trials · 3 indications
Measured as hour per nanomoles per liter (h\*nmol/L).
Measured as number of events.
Number of events.
Number of events.
Number of events.
| Arm | Type | Description |
|---|---|---|
| NNC0537-1482 | EXPERIMENTAL | Participants will be administered NNC0537-1482 single dose subcutaneously. |
| Cohort 1A | EXPERIMENTAL | Participants will be administered once weekly dose level 1 of NNC0537-1482 subcutaneously. |
| Cohort 2A | EXPERIMENTAL | Participants will be administered once weekly dose level 2 of NNC0537-1482 subcutaneously. |
| Cohort 3A | EXPERIMENTAL | Participants will be administered once weekly dose level 3 of NNC0537-1482 subcutaneously. |
| Cohort 4A | EXPERIMENTAL | Participants will be administered once weekly dose level 4 of NNC0537-1482 subcutaneously. |
| Cohort 5A | EXPERIMENTAL | Participants will be administered once weekly dose level 5 of NNC0537-1482 subcutaneously. |
| Cohort B | EXPERIMENTAL | Participants will be administered a selected safe and tolerable dose level of NNC0537-1482 subcutaneously. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered Placebo matched to NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 1 | EXPERIMENTAL | Participants will be administered a single dose of dose level 1 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 2 | EXPERIMENTAL | Participants will be administered a single dose of dose level 2 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 3 | EXPERIMENTAL | Participants will be administered a single dose of dose level 3 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 4 | EXPERIMENTAL | Participants will be administered a single dose of dose level 4 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 5 | EXPERIMENTAL | Participants will be administered a single dose of dose level 5 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 6 | EXPERIMENTAL | Participants will be administered a single dose of dose level 6 of NNC0537-1482 subcutaneously. |
| Name | Type | Description |
|---|---|---|
| NNC0537-1482 | DRUG | NNC0537-1482 will be administered subcutaneously. |
| Placebo (for dilution only) | OTHER | A placebo was used for dilution of the investigational medicinal product. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
Inclusion Criteria: * Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m\^2) (both inclusive) at screening. * Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equat...
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NNC0537-1482 is an investigational small molecule medicine being developed by Novo Nordisk A/S. It is in Phase 1 clinical development and is being studied in chronic kidney disease and heart failure. It has not been approved for any use and remains an experimental therapy in early human testing.
NNC0537-1482 is being studied for chronic kidney disease and heart failure. One Phase 1 trial is evaluating how a single dose moves through the body of participants with normal or reduced kidney function, and another is assessing its effects in participants with heart failure. No approved use exists.
NNC0537-1482 is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is running the Phase 1 clinical program for the small molecule in chronic kidney disease and heart failure, with trials conducted in Germany, the United Kingdom, and the Netherlands.
NNC0537-1482 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulator. Three Phase 1 studies are listed, one completed, one recruiting, and one not yet recruiting, with a combined enrollment of 67 participants.
NNC0537-1482 has three Phase 1 trials. NCT07808788 is not yet recruiting and will study a single dose in participants with normal or reduced kidney function in Germany. NCT07218627 is recruiting participants with heart failure in the United Kingdom. NCT06625307, in healthy individuals in the Netherlands, is completed.
The three Phase 1 trials of NNC0537-1482 have a combined planned enrollment of 67 participants. NCT07808788 plans 54 participants, NCT07218627 plans 36, and the completed NCT06625307 enrolled 31. The studies are uncontrolled, not randomized, and not double blinded.