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
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.
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.
Current treatment with haemodialysis for at least 3 months prior to screening.
Exclusion Criteria:
Participants will be administered NNC0537-1482 single dose subcutaneously.
Drug: NNC0537-1482 · Other: Placebo (for dilution only)
NNC0537-1482 will be administered subcutaneously.
A placebo was used for dilution of the investigational medicinal product.
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
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
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
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
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
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
Number of treatment emergent adverse events (TEAEs)
Measured as Events.
Time frame: From time of trial product administration (Day 1) until Day 36
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisktrials.com
No publications or documents are linked to this record.
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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Novo Nordisk A/S