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A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
Sponsor: Novo Nordisk A/S
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2024-11-12
Completion Date
2026-03-18
Last Updated
2026-04-09
Healthy Volunteers
Yes
Conditions
Interventions
NNC0363-1063
NNC0363-1063 will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Insulin degludec
Insulin degludec will be administered subcutaneously.
Insulin detemir
Insulin detemir will be administered subcutaneously.
Locations (1)
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany