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

April 3, 2026 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: From IMP administration at day 1 up to 7 days
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
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).
At day 2 of visit 2 and visit 3 after initiation of meal test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Up to 2 days
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
Time Frame: Up to 7 days
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
Time Frame: Up to 7 days
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
Time Frame: Up to 2 days
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
Time Frame: Up to 7 days
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
Time Frame: Up to 7 days
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
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.
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
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.
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
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.
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
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.
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
Time Frame: At day 2 of visit 2 and visit 3 after initiation of meal test
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
Time Frame: At day 2 of visit 2 and visit 3 after initiation of meal test
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
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.
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
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.
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
Time Frame: At day 2 of visit 2 and visit 3 after last IMP administration
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
Time Frame: At day 2 of visit 2 and visit 3 after last IMP administration
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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