Diabetes Mellitus, Type 2Phase 1NCT07004322
A Research Study of the New Medicine NNC0519-0130 in Male Chinese Participants Living With Excess Body Weight
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 China.
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 excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2025to 28 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male Chinese participant.
- Body Mass Index (BMI) between 24.0 and 39.9 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 eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- 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.
- 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 (including Chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), domperidone or topical medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital, Northern Branch-Phase I
Beijing, Beijing Municipality, 100089
About this study
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Male Chinese Participants With Overweight or Obesity
Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
- 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 matched to NNC0519-0130 will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner. Receives: Drug: NNC0519-0130 |
| Placebo | Placebo comparator | Participants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From pre-dose up to 7 days post-dose
Secondary outcomes (3)
Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period
Measured in nanomoles per liter (nmol/L).
Measured: From pre-dose up to 7 days post-dose
t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose
Measured in hours (h).
Measured: From pre-dose until completion of the follow-up visit (day 162)
Number of treatment emergent adverse events (TEAEs)
Measured in number of events.
Measured: From time of first dosing (day 1) until completion of the end of study visit (day 162)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start26 May 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
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
- 20 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
- NCT07004322
- Sponsor's protocol ID
- NN9541-4918
- Other IDs
- U1111-1283-0622
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Male Chinese Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07004322
- Acronym / sponsor ID
- NN9541-4918
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 4 Jun 2025 (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 excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.
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 once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male Chinese participant.
- Body Mass Index (BMI) between 24.0 and 39.9 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 eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (4 listed)
- 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.
- 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 (including Chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), domperidone or topical medication.
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 matched to NNC0519-0130 will be administered subcutaneously. | Drug | Placebo |
Primary outcome
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
Time frame: From pre-dose up to 7 days post-dose
Measured in hours*nanomoles per liter (h*nmol/L).
3 secondary outcomes
Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period
Time frame: From pre-dose up to 7 days post-dose
t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose
Time frame: From pre-dose until completion of the follow-up visit (day 162)
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 162)
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 Mar 2026.
- 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 China.
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 3 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 31 Mar 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 China. 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?
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period (time frame: From pre-dose up to 7 days post-dose). 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 Mar 2026.