drugset / Trial / NCT06685185
A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
RandomizedSequentialQuadruple-blindTreatment
Summary
This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.
Timeline
- Start
- 2024-11-12
- Primary completion
- 2026-03-08
- Completion
- 2026-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NNC0363-1063 | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |