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

Sponsor
Novo Nordisk A/S
Study ID
NCT06685185
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • NNC0363-1063 — DRUG
    NNC0363-1063 will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.
  • Insulin degludec — DRUG
    Insulin degludec will be administered subcutaneously.
  • Insulin detemir — DRUG
    Insulin detemir will be administered subcutaneously.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Apr 2026
Primary completion
Mar 8, 2026
Completion
Mar 18, 2026

Study Design

Enrollment
117 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: SAD: NNC0363-1063
    Participants will receive single dose of NNC0363-1063 subcutaneously.
  • Placebo Comparator: Part 1A: SAD: Placebo
    Participants will receive NNC0363-1063 matching placebo subcutaneously.
  • Experimental: Part 1B: SAD: NNC0363-1063
    Participants will receive NNC0363-1063 subcutaneously.
  • Active Comparator: Part 1B: SAD: Insulin degludec
    Participants will receive insulin degludec subcutaneously.
  • Experimental: Part 2: PoP: NNC0363-1063
    Participants will receive NNC0363-1063 subcutaneously.
  • Experimental: Part 3 Meal test: NNC0363-1063
    Participants will receive NNC0363-1063 subcutaneously.
  • Active Comparator: Part 3 Meal test: Insulin detemir
    Participants will receive insulin detemir subcutaneously.

Primary Outcome Measure

Part 1 SAD: Number of adverse events [ Time Frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8) ]

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