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Do you suffer from Chronic Kidney Disease, as well as Type 2 Diabetes?
This clinical research study is evaluating an experimental treatment for people with Chronic Kidney Disease, who also suffer from Type 2 Diabetes. The study will compare the effectiveness of CagriSema (an investigational medication), to semaglutide, cagrilintide and placebo.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with chronic kidney disease, and whether it will be made widely available to all Canadians. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 18 years of age or older at the time of providing informed consent.
- Have a BMI greater than or equal to 27 kg/m^2 (You can calculate your BMI using this tool: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm).
- Have been diagnosed with type 2 diabetes mellitus for greater than or equal to 6 months before screening.
- Have been treated with the maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
You may not qualify to participate if you:
- Are pregnant, breast-feeding or intend to become pregnant, or are of child-bearing potential and not using a highly effective contraceptive method.
- Have participated in any other interventional clinical study within 60 days before screening.
- Experience congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases or congenital urinary tract malformations.
- Have used any GLP-1RA or amylin analogue within 60 days prior to screening
- Have a personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Have experienced myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
- Experience chronic heart failure.
- Have a planned coronary, carotid or peripheral artery revascularization.
- Have uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- Have had a prior solid organ transplant, or are awaiting a solid organ transplant.
- Have experienced acute pancreatitis within 6 months prior to screening.
- Have a history of chronic pancreatitis.
- Have been treated with any medication for the indication of obesity within 3 months before screening.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
