Investigation of pharmacokinetics of a single subcutaneous dose of NNC0537-1482 in participants with various degrees of renal function

NCT ID NCT07808788

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117, Germany

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