[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655234":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":47,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":81,"collaborators":32,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":32,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":32,"overallStatus":102,"whyStopped":32,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Novo Nordisk A\u002FS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002FL).","From pre-dose (Day 1) until Day 36",[14,17,20,23,26,28],{"measure":15,"description":16,"timeFrame":12},"Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment","Measured as nanomoles per liter (nmol\u002FL).",{"measure":18,"description":19,"timeFrame":12},"Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment","Measured as hours.",{"measure":21,"description":22,"timeFrame":12},"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\u002FL.",{"measure":24,"description":25,"timeFrame":12},"Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)","Measured as nmol\u002FL.",{"measure":27,"description":19,"timeFrame":12},"Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)",{"measure":29,"description":30,"timeFrame":31},"Number of treatment emergent adverse events (TEAEs)","Measured as Events.","From time of trial product administration (Day 1) until Day 36",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"NNC0537-1482","EXPERIMENTAL","Participants will be administered NNC0537-1482 single dose subcutaneously.",[45,46],"Drug: NNC0537-1482","Other: Placebo (for dilution only)",[48,52],{"type":49,"name":41,"description":50,"armGroupLabels":51,"otherNames":32},"DRUG","NNC0537-1482 will be administered subcutaneously.",[41],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"OTHER","Placebo (for dilution only)","A placebo was used for dilution of the investigational medicinal product.",[41],[58],{"name":59,"affiliation":60,"role":61},"Clinical Transparency dept. 2834","Organizational Affiliation Enter 'Novo Nordisk A\u002FS","STUDY_DIRECTOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":32,"email":67},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[69],{"facility":70,"status":32,"city":71,"state":32,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":32},"Charité - Campus Charité Mitte - Charité Research Organisation GmbH","Berlin","10117","Germany","DE",{"type":76,"coordinates":77},"Point",[78,79],13.41053,52.52437,{"lat":79,"lon":78},{"type":82,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100655234","phase-1-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-100655234",false,"NCT07808788","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","Investigation of Pharmacokinetics of a Single Subcutaneous Dose of NNC0537-1482 in Participants With Various Degrees of Renal Function","Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg\u002Fm\\^2) (both inclusive) at screening.\n* 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\u002Fhave 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):\n\nNormal 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 (\\\u003C)15 and requiring dialysis treatment.\n\n* All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.\n* For participants with ESRD requiring dialysis treatment:\n\nCurrent treatment with haemodialysis for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).\n* 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).\n* 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\u002Fneprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.\n* 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\u002Fcontinuous use); dose, time of administration and reason should be documented in the source documents.\n* Specific exclusion criterion for participants with normal renal function:\n* 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.\n* Specific exclusion criterion for participants with renal impairment or ESRD:\n* Blood pressure at screening outside the range of 100-160 mmHg for systolic and\u002For ≥100 mmHg for diastolic.\n* 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.","ALL","18 Years","75 Years",{"count":94,"type":95},54,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","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.",[101],"Chronic Kidney Disease","NOT_YET_RECRUITING","2026-09-02",{"date":105,"type":106},"2026-09-09","ACTUAL",{"date":108,"type":95},"2026-09-04",{"date":110,"type":95},"2027-07-06",{"name":5,"class":6},1]