ObesityPhase 1NCT06718998
A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity
A Phase 1 study testing NNC0519-0130 in people with Obesity, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0519-0130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteAustria
- Study dates
- 20 Nov 2024to 12 Jan 2026
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female of non-childbearing potential, or male.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be otherwise 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.
Who cannot join
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percentage (48 millimoles per mole [mmol/mol]) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.
- Conditions
- Obesity
- Being tested
- NNC0519-0130
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0519-0130Drug
Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: NNC0519-0130 | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase. Receives: Drug: NNC0519-0130 |
| Arm 2: NNC0519-0130 | Experimental | Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase. Receives: Drug: NNC0519-0130 |
| Arm 3: NNC0519-0130 | Experimental | Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase. Receives: Drug: NNC0519-0130 |
| Arm 4: NNC0519-0130 | Experimental | Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase. Receives: Drug: NNC0519-0130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Measured as number of events.
Measured: From randomisation (week 0) to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Nov 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- None (open label)
- Enrolment
- 134 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
- NCT06718998
- Sponsor's protocol ID
- NN9541-7760
- Other IDs
- U1111-1298-9340, 2023-508940-23, 2023
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2024
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06718998
- Acronym / sponsor ID
- NN9541-7760
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 5 Dec 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.
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase. |
| Arm 2: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase. |
| Arm 3: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase. |
| Arm 4: NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female of non-childbearing potential, or male.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be otherwise 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.
Key exclusion criteria (4 listed)
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percentage (48 millimoles per mole [mmol/mol]) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
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 |
|---|---|---|
| NNC0519-0130Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously. | Drug | Arm 1: NNC0519-0130, Arm 2: NNC0519-0130, Arm 3: NNC0519-0130, Arm 4: NNC0519-0130 |
Primary outcome
Number of Adverse Events (AEs)
Time frame: From randomisation (week 0) to week 18
Measured as number of events.
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 3 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Obesity
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 Obesity, run by Novo Nordisk A/S at 1 site in Austria.
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 4 inclusion and 4 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 3 Apr 2026. 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 Austria. 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 Adverse Events (AEs) (time frame: From randomisation (week 0) to week 18). 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 3 Apr 2026.