NCT06685185

A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	NNC0363-1063	NNC0363-1063 will be administered subcutaneously.
DRUG	Placebo	Placebo will be administered subcutaneously.
DRUG	Insulin degludec	Insulin degludec will be administered subcutaneously.
DRUG	Insulin detemir	Insulin detemir will be administered subcutaneously.

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-03-08
• Completion: 2026-03-18
• First posted: 2024-11-12
• Last updated: 2026-04-09

Locations

1 site across 1 country: Germany