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

Phase 1

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: NNC0363-1063; Drug: Placebo; Drug: Insulin degludec

• Registration Number: NCT06685185
• Lead Sponsor: Novo Nordisk A/S

Brief 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 las...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-09
• Study Start: 2024-11-12
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-07-24
• Study Completion: 2025-07-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1A: SAD: NNC0363-1063	NNC0363-1063	Participants will receive single dose of NNC0363-1063 subcutaneously.
Part 1A: SAD: Placebo	Placebo	Participants will receive NNC0363-1063 matching placebo subcutaneously.
Part 1B: SAD: NNC0363-1063	NNC0363-1063	Participants will receive NNC0363-1063 subcutaneously.
Part 1B: SAD: Insulin degludec	Insulin degludec	Participants will receive insulin degludec subcutaneously.
Part 2: PoP: NNC0363-1063	NNC0363-1063	Participants will receive NNC0363-1063 subcutaneously.
Part 3: MAD: NNC0363-1063	NNC0363-1063	Participants will receive NNC0363-1063 subcutaneously.
Part 3: MAD: Insulin degludec	Insulin degludec	Participants will receive insulin degludec subcutaneously.

Primary Outcome Measures

Name	Time	Method
Part 1 SAD: Number of adverse events	From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)	Measured in number of events.
Part 3 MAD: Number of adverse events	From IMP administration at day 1 until day of the end of study visit at day 15	Measured in number of events.
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose	From IMP administration at day 1 up to 7 days	Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).

Secondary Outcome Measures

Name	Time	Method
Part 1 SAD: Number of hypoglycaemic episodes	From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)	Measured in number of episodes.
Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose	Up to 7 days	Measured in hours\*picomoles per litre(h\*pmol/L).
Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose	Up to 2 days	Measured in h\*pmol/L.
Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose	Up to 7 days	Measured in picomoles per litre (pmol/L).
Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose	Up to 7 days	Measured in h\*pmol/L.
Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose	Up to 2 days	Measured in h\*pmol/L.
Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose	Up to 7 days	Measured in pmol/L.
Part 3 MAD: Number of hypoglycaemic episodes	From IMP administration (day 1) until day of the end of study visit (day 15)	Measured in number of episodes.
Part 3 MAD: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state	At day 5 and 8	Measured in h\*pmol/L.
Part 3 MAD: Cmax,I1063,SS- Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state	At day 5 and 8	Measured in pmol/L.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany