How NNC0537-1482 moves through the body in people with different kidney function

Trial details

Who runs it

Novo Nordisk A/S

Trial code

NCT07808788

Record updated

9 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: 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; 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; 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); Specific exclusion criterion for participants 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); 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; Blood pressure at screening outside the range of 100-160 mmHg for systolic and/or ≥100 mmHg for diastolic.

ClinicalTrials.gov NCT07808788