This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
626
Participants will receive Cagrilintide subcutaneously.
Participants will receive semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
John Muir Physicians Network
Concord, California, United States
Valley Research
Fresno, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
North America Research Institute
San Dimas, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Change in urinary albumin-to-creatinine ratio (UACR)
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)
Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2).
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in eGFR (creatinine-based CKD-EPI 2021)
Measured in mL/min/1.73 m\^2.
Time frame: From baseline (week 0) to end of treatment (week 26)
Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 26)
Achievement of greater than or equal to (≥) 5 % weight reduction
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 26)
Achievement of ≥ 10 % weight reduction
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in waist circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in glycated haemoglobin (HbA1c)
Measured in %-points.
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 26)
Change in diastolic blood pressure
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 26)
Number of treatment emergent adverse events (TEAEs)
count of events.
Time frame: From baseline (week 0) to end of study (week 32)
Number of treatment emergent serious adverse events (SAEs)
count of events.
Time frame: From baseline (week 0) to end of study (week 32)
Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL]))
Count of episodes.
Time frame: From baseline (week 0) to end of study (week 32)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Count of episodes.
Time frame: From baseline (week 0) to end of study (week 32)
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