Diabetes Mellitus, Type 2Phase 1NCT06567041
A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes
A Phase 1 study testing NNC0519-0130 in people with Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- NNC0519-0130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 7 Aug 2024to 10 Dec 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- 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.
- Participants with obesity only:
- Body mass index between 30.0 kilogram per meter square (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.
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- Participants with type 2 diabetes with either overweight or obesity:
- Body mass index between 27.0 kg/m^2 and 39.9kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening.
- Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive).
Who cannot join
- Any condition, except T2D and hypertension, 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 diabetes mellitus and hypertension).
- Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
- Participant is breastfeeding.
- Participants with obesity only:
- HbA1c ≥ 6.5 % (48 millimoles per mol [mmol/mol]) at screening.
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- Participants with type 2 diabetes with either overweight or obesity:
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Recurrent severe hypoglycaemia within the last year as judged by the investigator.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Weekly Doses of NNC0519-0130 in Participants With Obesity and in Participants With Type 2 Diabetes With Either Overweight or Obesity
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- NNC0519-0130, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0519-0130Drug
NNC0519-0130 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 once weekly (QW) subcutaneously(s.c.). Receives: Drug: NNC0519-0130 |
| Placebo | Placebo comparator | Participants will receive once weekly s.c. volume-matched placebo to NNC0519-0130. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured in number of events.
Measured: From time of first dosing (day 1) until completion of the end of study visit (day 274/253)
Secondary outcomes (4)
Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI)
Measured in milliseconds (ms).
Measured: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF)
Measured in ms.
Measured: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Area under the NNC0519-0130 plasma concentration-time curve in steady state
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Maximum plasma concentration of NNC0519-0130 in steady state
Measured in nanomoles per liter (nmol/L).
Measured: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start7 Aug 2024
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567041
- Sponsor's protocol ID
- NN9541-8116
- Other IDs
- U1111-1305-5164, 2024-512719-28
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Weekly Doses of NNC0519-0130 in Participants With Obesity and in Participants With Type 2 Diabetes With Either Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06567041
- Acronym / sponsor ID
- NN9541-8116
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive NNC0519-0130 once weekly (QW) subcutaneously(s.c.). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once weekly s.c. volume-matched placebo to NNC0519-0130. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- 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.
- Body mass index between 30.0 kilogram per meter square (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.
Key exclusion criteria (10 listed)
- Any condition, except T2D and hypertension, 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 diabetes mellitus and hypertension).
- Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
- Participant is breastfeeding.
- HbA1c ≥ 6.5 % (48 millimoles per mol [mmol/mol]) at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0519-0130NNC0519-0130 will be administered subcutaneously. | Drug | NNC0519-0130 |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Number of adverse events
Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 274/253)
Measured in number of events.
4 secondary outcomes
Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI)
Time frame: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF)
Time frame: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Area under the NNC0519-0130 plasma concentration-time curve in steady state
Time frame: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Maximum plasma concentration of NNC0519-0130 in steady state
Time frame: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0519-0130 in people with Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 1 site in Germany.
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 10 inclusion and 10 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 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 adverse events (time frame: From time of first dosing (day 1) until completion of the end of study visit (day 274/253)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.