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Chronic Kidney DiseasePhase 1NCT07808788

A Research Study Looking Into How a Single Dose of the Medicine NNC0537-1482 Moves Through the Body of Participants With Normal or Reduced Kidney Function

A Phase 1 study testing NNC0537-1482 in people with Chronic Kidney Disease, run by Novo Nordisk A/S at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function. All participants will get a single dose of the new medicine. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Kidney Disease
What is being tested?
NNC0537-1482
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteGermany
Study dates
4 Sep 2026to 6 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m^2) (both inclusive) at screening.
  • Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area for any of the below renal function groups at screening (Note: The participant must be/have been in their usual health condition at the time of sample collection used for inclusion, as evaluated by the investigator. This will indicate that the participant does not have an acute kidney dysfunction):
  • Normal renal function: greater than or equal to (≥) 90, Mild renal impairment: 60-89, Moderate renal impairment: 30-59, Severe renal impairment: 15-29 not requiring dialysis, ESRD: less than (<)15 and requiring dialysis treatment.
  • All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.
  • For participants with ESRD requiring dialysis treatment:
  • Current treatment with haemodialysis for at least 3 months prior to screening.

Who cannot join

  • Any condition 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, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
  • Use of medicinal products 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 with the investigational medicinal product (IMP).
  • Ongoing treatment with nitrates or nitric oxide (NO) donors (for any route; including isosorbide dinitrate, isosorbide 5 mononitrate, pentaerythritol tetranitrate, nicorandil, nitroglycerin , molsidomine), neprilysin inhibitors (including angiotensin receptor/neprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.
  • Note for participants on dialysis: short-term use of nitroglycerin spray for acute hypertensive episodes or emergencies may be permitted at the investigator's discretion if nitroglycerin is administered as single, short acting dose to treat an acute event (i.e., not scheduled, not for chronic/continuous use); dose, time of administration and reason should be documented in the source documents.
  • Specific exclusion criterion for participants with normal renal function:
Show all 10Show fewer
  • Blood pressure at screening outside the range of 100-145 millimetres of mercury (mmHg) for systolic or outside the range of 50-99 mmHg for diastolic.
  • Specific exclusion criterion for participants with renal impairment or ESRD:
  • Blood pressure at screening outside the range of 100-160 mmHg for systolic and/or ≥100 mmHg for diastolic.
  • Unstable renal function within the last 3 months before screening as judged by the investigator, or acute exacerbation of renal disease within 14 days before screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Germany1 site

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

Official title: Investigation of Pharmacokinetics of a Single Subcutaneous Dose of NNC0537-1482 in Participants With Various Degrees of Renal Function

The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function. All participants will get a single dose of the new medicine. The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.

Being tested
NNC0537-1482, Placebo (for dilution only)
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0537-1482Drug

    NNC0537-1482 will be administered subcutaneously.

  • Placebo (for dilution only)Other

    A placebo was used for dilution of the investigational medicinal product.

Study groups in NCT07808788
Study groupRoleWhat they receive
NNC0537-1482ExperimentalParticipants will be administered NNC0537-1482 single dose subcutaneously.
Receives: Drug: NNC0537-1482; Other: Placebo (for dilution only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment

    Measured as hour per nanomoles per liter (h*nmol/L).

    Measured: From pre-dose (Day 1) until Day 36

Secondary outcomes (6)

  1. Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment

    Measured as nanomoles per liter (nmol/L).

    Measured: From pre-dose (Day 1) until Day 36

  2. Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment

    Measured as hours.

    Measured: From pre-dose (Day 1) until Day 36

  3. Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with end-stage renal disease (ESRD)

    Measured as h*nmol/L.

    Measured: From pre-dose (Day 1) until Day 36

  4. Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)

    Measured as nmol/L.

    Measured: From pre-dose (Day 1) until Day 36

  5. Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)

    Measured as hours.

    Measured: From pre-dose (Day 1) until Day 36

  6. Number of treatment emergent adverse events (TEAEs)

    Measured as Events.

    Measured: From time of trial product administration (Day 1) until Day 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start4 Sep 2026 (estimated)
  3. Primary completion6 Jul 2027 (estimated)
  4. Study completion6 Jul 2027 (estimated)

Resources

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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07808788
Sponsor's protocol ID
NN6537-8759
Other IDs
U1111-1335-3619, 2026-525271-57
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0537-1482 in people with Chronic Kidney Disease, 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 6 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: opening soon, as of the sponsor's last update on 9 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment (time frame: From pre-dose (Day 1) until Day 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07808788.

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 9 Sep 2026.

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