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Not yet recruitingNCT07808788Updated Sep 9, 2026

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 interventional study of NNC0537-1482 and Placebo (for dilution only) in Chronic Kidney Disease, sponsored by Novo Nordisk A/S. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.

02

Conditions studied

  • Chronic Kidney Disease
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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:
  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    NNC0537-1482

    Participants will be administered NNC0537-1482 single dose subcutaneously.

    Drug: NNC0537-1482 · Other: Placebo (for dilution only)

Interventions

  • DrugNNC0537-1482

    NNC0537-1482 will be administered subcutaneously.

  • OtherPlacebo (for dilution only)

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

05

What researchers measure

Primary outcomes

  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).

    Time frame: From pre-dose (Day 1) until Day 36

Secondary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From pre-dose (Day 1) until Day 36

  6. Number of treatment emergent adverse events (TEAEs)

    Measured as Events.

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

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Study locations

1 site
  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH
    Berlin, 10117, Germany
07

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisktrials.com

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07808788
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 4, 2026 (estimated)
Primary completion
Jul 6, 2027 (estimated)
Completion
Jul 6, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency dept. 2834
study director · Organizational Affiliation Enter 'Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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