Diabetes Mellitus, Type 2Phase 1NCT05870670
A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men
A Phase 1 study testing NNC0519-0130 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- 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
- 22 participants
- Where
- 1 siteJapan
- Study dates
- 15 May 2023to 16 Oct 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 23.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). 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.
- For Japanese participants: Both parents of Japanese descent.
- For non-Japanese participants: Both parents of Caucasian descent.
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.
- Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (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 (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Japanese and Non-Japanese Male Participants
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0519-0130, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0519-0130Drug
Administered subcutaneously.
PlaceboDrug
Administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0519-0130 | Experimental | Escalating multiple doses of NNC0519-0130 administered subcutaneously. Receives: Drug: NNC0519-0130 |
| Placebo | Placebo comparator | Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period
Measured in h*nmol/L.
Measured: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Secondary outcomes (2)
Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period
Measured in nmol/L.
Measured: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as number of events.
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 105)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 May 2023
- Primary completion7 Oct 2023
- Study completion16 Oct 2023
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
- 22 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
- NCT05870670
- Sponsor's protocol ID
- NN9541-4921
- Other IDs
- U1111-1283-0710
- Status last verified
- Jun 2025
- First submitted
- 12 May 2023
- Last updated
- 18 Jun 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 18 Jun 2025. 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 Japanese and Non-Japanese Male Participants
- ClinicalTrials.gov ID
- NCT05870670
- Acronym / sponsor ID
- NN9541-4921
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 23 May 2023 (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.
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.
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: NNC0519-0130Escalating multiple doses of NNC0519-0130 administered subcutaneously. |
| Placebo | Placebo comparator | Drug: PlaceboEscalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 23.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). 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.
- For Japanese participants: Both parents of Japanese descent.
- For non-Japanese participants: Both parents of Caucasian descent.
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.
- Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (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 (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before 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 |
|---|---|---|
| NNC0519-0130Administered subcutaneously. | Drug | NNC0519-0130 |
| PlaceboAdministered subcutaneously. | Drug | Placebo |
Primary outcome
AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period
Time frame: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Measured in h*nmol/L.
2 secondary outcomes
Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period
Time frame: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 105)
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 18 Jun 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, run by Novo Nordisk A/S at 1 site in Japan.
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 18 Jun 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 Japan. 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?
AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period (time frame: From pre-dose until 24 hours post-dose relative to last dose in each treatment period). 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 18 Jun 2025.