Diabetes Mellitus, Type 2Phase 1NCT06370819
A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function
A Phase 1 study testing NNC0519-0130 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy 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?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2024to 27 Nov 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:
- For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)
- Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
- Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min
- Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
- Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment
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 (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117
About this study
Official title: Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of Renal Function
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0519-0130
- 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
NNC0519-0130 will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0519-0130 | Experimental | Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130. Receives: Drug: NNC0519-0130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment
Measured in hours* nanomoles per litre (h*nmol/L).
Measured: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Secondary outcomes (4)
Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment
Measured in nanomoles per litre (nmol/L).
Measured: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure
Measured in hours* nanomoles per litre (h*nmol/L).
Measured: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure
Measured in nanomoles per litre (nmol/L).
Measured: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Number of adverse events
Number of events.
Measured: From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 Apr 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT06370819
- Sponsor's protocol ID
- NN9541-4923
- Other IDs
- U1111-1292-3441, 2023-506381-32, 2023
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2024
- Last updated
- 7 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT06370819
- Acronym / sponsor ID
- NN9541-4923
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 17 Apr 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.
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0519-0130 | Experimental | Drug: NNC0519-0130Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:
- For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)
- Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
Key exclusion criteria (3 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 (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
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 |
Primary outcome
Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment
Time frame: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Measured in hours* nanomoles per litre (h*nmol/L).
4 secondary outcomes
Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment
Time frame: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure
Time frame: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure
Time frame: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Number of adverse events
Time frame: From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)
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 7 Apr 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, 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 8 inclusion and 3 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 7 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 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. 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?
Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment (time frame: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)). 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 7 Apr 2026.