The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
465
NNC0519-0130 will be administered subcutaneously.
Placebo matching NNC0519-0130 will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
N America Res Inst - San Dimas
San Dimas, California, United States
ACTIVE_NOT_RECRUITINGNorCal Endocrinology and Internal Medicine
San Ramon, California, United States
ACTIVE_NOT_RECRUITINGRocky Mount Reg VA Med-DN
Aurora, Colorado, United States
COMPLETEDNortheast Research Institute
Fleming Island, Florida, United States
ACTIVE_NOT_RECRUITINGChange in urinary albumin-to-creatinine ratio (UACR) at week 12
Measured as a ratio to baseline.
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 12)
Change in urinary albumin-to-creatinine ratio (UACR) at week 24
Measured as a ratio to baseline.
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 24)
Change in urinary albumin-to-creatinine ratio (UACR) at week 36
Measured as a ratio to baseline.
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 36)
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)
Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2).
Time frame: From baseline (week 0) to end of treatment (week 36)
Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
Measured in centimetres (cm).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in glycated haemoglobin (HbA1c)
Measured in percentage point (%-point).
Time frame: From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
Change in systolic blood pressure
Measured in millimetres of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in diastolic blood pressure
Measured in millimetres of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 40)
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Encore Medical Research LLC
Hollywood, Florida, United States
ACTIVE_NOT_RECRUITINGNortheast Research Institute
Saint Augustine, Florida, United States
ACTIVE_NOT_RECRUITINGClinical Research of Cent FL
Winter Haven, Florida, United States
COMPLETEDEndeavor Health
Skokie, Illinois, United States
COMPLETEDVelocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
ACTIVE_NOT_RECRUITINGElite Research Center
Flint, Michigan, United States
COMPLETED...and 137 more locations