Last updated 35 days ago
A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
618 patients around the world
Available in Spain, Brazil, Argentina, United States
Novo Nordisk A/S
618Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Diabetes
Diabetes mellitus type 2
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female.Age 18 years or above at the time of signing the informed consent.Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening.HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole [mmol/mol]) as assessed by central laboratory at screening.Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 milliliters per minutes per 1.73^m^2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed by central laboratory at screening.Albuminuria defined by UACR ≥ 100 and < 5000 milligram per gram (mg/g) as assessed by central laboratory at screening.Treatment with 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.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening.Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) within 5 years before screening.
SponsorNovo Nordisk A/S
Conditions
Chronic kidney diseaseDiabetes mellitus type 2Obesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06131372
