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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Placebo; Drug: NNC0363-1063; Drug: Insulin degludec; Drug: Insulin detemir

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A: SAD: NNC0363-1063; Participants will receive single dose of NNC0363-1063 subcutaneously.	Drug: NNC0363-1063; NNC0363-1063 will be administered subcutaneously.
Placebo Comparator: Part 1A: SAD: Placebo; Participants will receive NNC0363-1063 matching placebo subcutaneously.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Part 1B: SAD: NNC0363-1063; Participants will receive NNC0363-1063 subcutaneously.	Drug: NNC0363-1063; NNC0363-1063 will be administered subcutaneously.
Active Comparator: Part 1B: SAD: Insulin degludec; Participants will receive insulin degludec subcutaneously.	Drug: Insulin degludec; Insulin degludec will be administered subcutaneously.; Other Names: Tresiba
Experimental: Part 2: PoP: NNC0363-1063; Participants will receive NNC0363-1063 subcutaneously.	Drug: NNC0363-1063; NNC0363-1063 will be administered subcutaneously.
Experimental: Part 3 Meal test: NNC0363-1063; Participants will receive NNC0363-1063 subcutaneously.	Drug: NNC0363-1063; NNC0363-1063 will be administered subcutaneously.
Active Comparator: Part 3 Meal test: Insulin detemir; Participants will receive insulin detemir subcutaneously.	Drug: Insulin detemir; Insulin detemir will be administered subcutaneously.; Other Names: Levemir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 SAD: Number of adverse events	Measured in number of events.	From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose	Measured in millilitre per hour*kilogram (mL/[h*kg]).	From IMP administration at day 1 up to 7 days
Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state	Measured in hours*millimoles per litre (h*mmol/L).	At day 2 of visit 2 and visit 3 after initiation of meal test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 SAD: Number of hypoglycaemic episodes	Measured in number of episodes.	From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose	Measured in h*pmol/L.	Up to 2 days
Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose	Measured in picomoles per litre (pmol/L).	Up to 7 days
Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose	Measured in h*pmol/L.	Up to 7 days
Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose	Measured in h*pmol/L.	Up to 2 days
Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose	Measured in pmol/L.	Up to 7 days
Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose	Measured in hours*picomoles per litre (h*pmol/L).	Up to 7 days
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	Measured in h*mmol/L.	From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
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	Measured in h*mmol/L.	From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
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	Measured in h*mmol/L.	From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
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	Measured in h*mmol/L.	From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state	Measured in millimoles per litre (mmol/L).	At day 2 of visit 2 and visit 3 after initiation of meal test
Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state	Measured in hours.	At day 2 of visit 2 and visit 3 after initiation of meal test
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	Measured in mmol/L.	From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
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	Measured in mmol/L.	From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state	Measured in h*pmol/L.	At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state	Measured in pmol/L.	At day 2 of visit 2 and visit 3 after last IMP administration
Part 3 Meal test: Number of adverse events	Measured in number of events.	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)
Part 3 Meal test: Number of hypoglycaemic episodes	Measured in number of episodes.	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): March 8, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin Detemir; insulin degludec
• Other Study ID Numbers: NN1644-7794; 2024-511808-17 (Other Identifier: European Medical Agency (EMA)); U1111-1304-2544 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No