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CagriSema in Chronic Kidney Disease, Type 2 Diabetes, and Overweight/Obesity
NCT06131372Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2024
- Primary completion
- Sep 2025
- Countries
- 13
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- CagriSema
- Conditions
- chronic kidney disease (CKD)type 2 diabetes mellitus (T2DM)obesity
01
Overview
Phase 2, randomised, double-blind trial of CagriSema in chronic kidney disease (CKD), type 2 diabetes mellitus (T2DM) and obesity (4 arms), sponsored by Novo Nordisk. Primary endpoint: Change in urinary albumin-to-creatinine ratio at 26 weeks. Started Apr 2024; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
CagriSema
Cagrilintide and semaglutide SC once-weekly
Semaglutide
Semaglutide and placebo SC once-weekly
Cagrilintide
Cagrilintide and placebo SC once-weekly
Placebo
Placebo SC once-weekly
03
Who it enrols
Adults with type 2 diabetes, overweight/obesity (BMI >= 27), and chronic kidney disease (eGFR 15-90, UACR 100-5000) on stable ACEi/ARB therapy.
04
Endpoints
Primary
Change in urinary albumin-to-creatinine ratio
Secondary
Change in estimated glomerular filtration rate
Relative change in body weight
Achievement of >= 5 % weight reduction
Achievement of >= 10 % weight reduction
Change in waist circumference
Change in glycated haemoglobin
Change in systolic blood pressure
Change in diastolic blood pressure
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