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Completed

NCT Number: NCT06685185

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Meal test (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 Meal test (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.

Treatment and study plan

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.

Other names: Tresiba

insulin detemir

Drug

Insulin detemir will be administered subcutaneously.

Other names: Levemir

Primary outcomes

  1. Part 1 SAD: Number of adverse events

    Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

    Measured in number of events.

  2. Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose

    Time frame: From IMP administration at day 1 up to 7 days

    Measured in millilitre per hour*kilogram (mL/[h*kg]).

  3. Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state

    Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

    Measured in hours*millimoles per litre (h*mmol/L).

Secondary outcomes

  1. Part 1 SAD: Number of hypoglycaemic episodes

    Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

    Measured in number of episodes.

  2. Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

    Time frame: Up to 7 days

    Measured in hours*picomoles per litre (h*pmol/L).

  3. Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose

    Time frame: Up to 2 days

    Measured in h*pmol/L.

  4. Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose

    Time frame: Up to 7 days

    Measured in picomoles per litre (pmol/L).

  5. Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

    Time frame: Up to 7 days

    Measured in h*pmol/L.

  6. Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose

    Time frame: Up to 2 days

    Measured in h*pmol/L.

  7. Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose

    Time frame: Up to 7 days

    Measured in pmol/L.

  8. Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state

    Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in h*mmol/L.

  9. Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state

    Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in h*mmol/L.

  10. Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state

    Time frame: From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in h*mmol/L.

  11. Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state

    Time frame: From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in h*mmol/L.

  12. Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state

    Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

    Measured in millimoles per litre (mmol/L).

  13. Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state

    Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

    Measured in hours.

  14. Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state

    Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in mmol/L.

  15. Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state

    Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

    Measured in mmol/L.

  16. Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state

    Time frame: At day 2 of visit 2 and visit 3 after last IMP administration

    Measured in h*pmol/L.

  17. Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state

    Time frame: At day 2 of visit 2 and visit 3 after last IMP administration

    Measured in pmol/L.

  18. Part 3 Meal test: Number of adverse events

    Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)

    Measured in number of events.

  19. Part 3 Meal test: Number of hypoglycaemic episodes

    Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)

    Measured in number of episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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