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Healthy Volunteers (Diabetes Mellitus, Type 2)Phase 1NCT05363774

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

A Phase 1 study testing NNC0519-0130 in people with Healthy Volunteers (Diabetes Mellitus, Type 2), run by Novo Nordisk A/S at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reducing overweight which is often present in participants with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
NNC0519-0130
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
3 sitesin 2 countries
Study dates
20 Apr 2022to 2 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Single ascending dose (SAD) part:
  • Male aged 18-55 years (both inclusive) at screening
  • Body mass index between 18.5 kilogram per meter square (kg/m^2) and 27.0 kg/m^2 (both inclusive) at 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
  • Multiple ascending dose (MAD) part (MAD QD and MAD QW):
  • Male aged 18-55 years (both inclusive) at screening
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  • Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
  • Considered eligible 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
  • Type 2 diabetes (T2D) part:
  • Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening
  • Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening
  • Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening
  • Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (>=) 60 days before screening
  • Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes
  • HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive)

Who cannot join

  • Single ascending dose (SAD) part:
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
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  • HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
  • Multiple ascending dose (MAD) part (MAD QD and MAD QW):
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
  • HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
  • Type 2 diabetes (T2D) part:
  • Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
  • Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products
  • Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • Profil GmbH & Co. KG

    Mainz, 55116

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

Denmark1 site

  • Novo Nordisk Investigational Site

    Søborg, 2860

Other trials in Denmark

About this study

Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of NNC0519-0130 in Healthy Participants and Multiple Subcutaneous and Oral Doses of NNC0519-0130 in Participants With Overweight or Obesity and Participants With Type 2 Diabetes

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reducing overweight which is often present in participants with type 2 diabetes. In this study NNC0519-0130 is given to humans for the first time. This study will be looking into how safe the new medicine NNC0519-0130 is and will measure its concentrations in the blood. Moreover, effects on blood sugar, blood fat and body weight will be tested. There are different study parts with different participants. Healthy participants (men), healthy participants (men) with high body weight and people with diabetes (men and women) take part. Single doses and multiple doses are tested and the medicine is studied as an injection or when given orally (as a tablet). The participants are invited to take part in a part of the study which will look at the effects of weekly injected doses of NNC0519-0130 taken over the course of several weeks. It is planned that participants will be given the study medicine once weekly. The dose will be increased every three weeks, if safety and tolerability allow. Participants will take up to six different dose levels. This means that the period with weekly injections of study medicine will in total last up to 18 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Which medicine participant gets is decided by chance. The injection of study medicine will be done by trained staff into the tissue underneath the skin of belly using a syringe and needle. The total duration of the study could last up to 25 weeks.

Being tested
NNC0519-0130, Placebo (NNC0519-0130)
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0519-0130Drug

    SAD part: Participants will receive up to six dose levels of subcutaneous NNC0519-0130 in a sequential manner with the dose increasing between cohorts.

    MAD part: The participants in first cohort will receive NNC0519-0130 subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels.

    T2D part: Participants will receive NNC0519-0130 up to two dose levels with dose escalation within the cohort.

    MAD QW part: Participants will receive NNC0519-0130 up to 6 dose levels.

  • Placebo (NNC0519-0130)Drug

    SAD part: Participants will receive up to six dose levels of subcutaneous placebo (NNC0519-0130) in a sequential manner with the dose increasing between cohorts.

    MAD part: Participants in first cohort will receive placebo (NNC0519-0130) subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels.

    T2D part: Participants will receive placebo (NNC0519-0130) up to two dose levels with dose escalation within the cohort.

    MAD QW part: Participants will receive Placebo up to 6 dose levels.

Study groups in NCT05363774
Study groupRoleWhat they receive
Single ascending dose (SAD) partExperimentalParticipants will receive up to six dose levels of subcutaneous NNC0519-0130 or matching placebo in a sequential manner with the dose increasing between cohorts.
Receives: Drug: NNC0519-0130; Drug: Placebo (NNC0519-0130)
Multiple ascending dose (MAD) QD partExperimentalMAD QD part comprises two cohorts in participants with overweight or obesity and a cohort in participants with type 2 diabetes (T2D). The participants in first cohort will receive NNC0519-0130 or matching placebo subcutaneously up to 5 dose levels, and the participants in the second MAD QD cohort will receive NNC0519-0130 or matching placebo orally up to 5 dose levels.
Receives: Drug: NNC0519-0130; Drug: Placebo (NNC0519-0130)
Type 2 diabetes (T2D) partExperimentalParticipants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort.
Receives: Drug: NNC0519-0130; Drug: Placebo (NNC0519-0130)
MAD QW partExperimentalMAD QW part comprises two cohorts in participants with overweight or obesity and who are otherwise generally healthy. The participants in first cohort will receive NNC0519-0130 and 2nd cohort will receive matching placebo subcutaneously up to 6 dose levels.
Receives: Drug: NNC0519-0130; Drug: Placebo (NNC0519-0130)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part

    Measured as Number of events

    Measured: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)

  2. Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort

    Measured as Number of events

    Measured: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

  3. Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort

    Measured as Number of events

    Measured: From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

  4. Number of treatment emergent adverse events (TEAE) in T2D QW cohort

    Measured as number of events

    Measured: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Secondary outcomes (9)

  1. AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose

    Measured in h*nmol/L

    Measured: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

  2. Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose

    Measure in nmol/L

    Measured: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

  3. Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort

    Measured as Number of events

    Measured: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days)

  4. AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part

    Measured in h*nmol/L

    Measured: From pre-dose (last dose in each treatment period) until 24 hours post-dose

  5. Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part

    Measured in nmol/L

    Measured: From pre-dose (last dose in each treatment period) until 24 hours postdose

  6. AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort

    Measured in h*nmol/L

    Measured: From pre-dose (last dose) until 168 hours post-dose

  7. Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort

    Measured in nmol/L

    Measured: From pre-dose (last dose) until 168 hours post-dose

  8. AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort

    measured in h*nmol/L

    Measured: From pre-dose (last dose in each treatment period) until 168 hours post-dose

  9. Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort

    Measured in nmol/L

    Measured: From pre-dose (last dose in each treatment period) until 168 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start20 Apr 2022
  3. Primary completion2 Apr 2024
  4. Study completion2 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363774
Sponsor's protocol ID
NN9541-4842
Other IDs
2021-004856-41, U1111-1267-4254
Status last verified
Dec 2025
First submitted
18 Apr 2022
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0519-0130 in people with Healthy Volunteers (Diabetes Mellitus, Type 2), run by Novo Nordisk A/S at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part (time frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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