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
- Conditions
- Chronic Kidney DiseaseType 2 DiabetesObesity
- Registration Number
- NCT06131372
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 618
Inclusion Criteria:<br><br> - Male or female.<br><br> - Age 18 years or above at the time of signing the informed consent.<br><br> - Diagnosed with type 2 diabetes mellitus = 180 days before screening.<br><br> - Body mass index (BMI) = 27.0 kilograms per meter square (kg/m^2) at screening. BMI<br> will be calculated in the eCRF (electronic case report form) based on height and<br> body weight at screening.<br><br> - HbA1c less than or equal to (=) 10.5% (91 millimoles per mole [mmol/mol]) as<br> assessed by central laboratory at screening.<br><br> - Kidney impairment defined by serum creatinine and cystatin C-based eGFR = 15 and <<br> 90 milliliters per minutes per 1.73^m^2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed<br> by central laboratory at screening.<br><br> - Albuminuria defined by UACR = 100 and < 5000 milligram per gram (mg/g) as assessed<br> by central laboratory at screening.<br><br> - Treatment with maximum labelled or tolerated dose of an angiotensin converting<br> enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such<br> treatment is contraindicated or not tolerated, in the opinion of the investigator.<br> Treatment dose must be stable for at least 30 days prior to screening.<br><br>Exclusion Criteria:<br><br> - Female who is pregnant, breast-feeding or intends to become pregnant or is of<br> childbearing potential and not using a highly effective contraceptive method.<br><br> - Congenital or hereditary kidney diseases including polycystic kidney disease,<br> autoimmune kidney diseases including glomerulonephritis or congenital urinary tract<br> malformations.<br><br> - Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication<br> with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to<br> screening.<br><br> - Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for<br> unstable angina pectoris within 60 days before screening.<br><br> - Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before<br> screening.<br><br> - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified<br> by a fundus examination performed within 90 days before screening or in the period<br> between screening and randomisation. Pharmacological pupil-dilation is a requirement<br> unless using a digital fundus photography camera specified for non-dilated<br> examination.<br><br> - Presence or history of malignant neoplasms or in situ carcinomas (other than basal<br> or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the<br> cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)<br> within 5 years before screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in urinary albumin-to-creatinine ratio (UACR)
- Secondary Outcome Measures
Name Time Method Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021);Change in eGFR (creatinine-based CKD-EPI 2021);Relative change in body weight;Achievement of greater than or equal to (=) 5 % weight reduction;Achievement of = 10 % weight reduction;Change in waist circumference;Change in glycated haemoglobin (HbA1c);Change in systolic blood pressure;Change in diastolic blood pressure;Number of treatment emergent adverse events (TEAEs);Number of treatment emergent serious adverse events (SAEs);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]));Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold