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NCT06685185
PHASE1

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany