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

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Novo Nordisk

Status and phase

Enrolling
Phase 1

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin degludec
Drug: Placebo
Drug: NNC0363-1063

Study type

Interventional

Funder types

Industry

Identifiers

NCT06685185
2024-511808-17 (Other Identifier)
U1111-1304-2544 (Other Identifier)
NN1644-7794

Details and patient eligibility

About

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 2½ to 6½ weeks. Part 3 is a multiple ascending dose (MAD) study part conducted in participants with T1D and will last for 3½ to 8½ weeks.

Enrollment

154 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Part 1A SAD (healthy participants)

  • Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body mass index between 18.5-29.9 kilogram per square metre( kg/m^2) (both inclusive) at the day of screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 1B SAD, Part 2 PoP and Part 3 MAD (participants with T1D)

  • Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body mass index between 18.5-29.9 kg/m^2 (both inclusive) at the day of screening.
  • Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening.
  • Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

Part 1A SAD (healthy participants)

  • Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
  • Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Part 1B SAD, Part 2 PoP and Part 3 MAD (participants with T1D)

  • Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
  • Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

154 participants in 7 patient groups, including a placebo group

Part 1A: SAD: NNC0363-1063
Experimental group
Description:
Participants will receive single dose of NNC0363-1063 subcutaneously.
Treatment:
Drug: NNC0363-1063
Part 1A: SAD: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0363-1063 matching placebo subcutaneously.
Treatment:
Drug: Placebo
Part 1B: SAD: NNC0363-1063
Experimental group
Description:
Participants will receive NNC0363-1063 subcutaneously.
Treatment:
Drug: NNC0363-1063
Part 1B: SAD: Insulin degludec
Active Comparator group
Description:
Participants will receive insulin degludec subcutaneously.
Treatment:
Drug: Insulin degludec
Part 2: PoP: NNC0363-1063
Experimental group
Description:
Participants will receive NNC0363-1063 subcutaneously.
Treatment:
Drug: NNC0363-1063
Part 3: MAD: NNC0363-1063
Experimental group
Description:
Participants will receive NNC0363-1063 subcutaneously.
Treatment:
Drug: NNC0363-1063
Part 3: MAD: Insulin degludec
Active Comparator group
Description:
Participants will receive insulin degludec subcutaneously.
Treatment:
Drug: Insulin degludec

Trial contacts and locations

1

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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