A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease

Sep 1, 2024Kidney international

Cotadutide's effects on kidney health in people with diabetic kidney disease: A randomized phase 2b trial

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Abstract

Cotadutide at 600 μg reduced urinary albumin-to-creatinine ratio by 49.9% at week 14 compared to placebo.

Patients with type 2 diabetes and chronic kidney disease participated in a phase 2b study.
The study involved 248 randomized patients with a mean age of 67.1 years and a mean eGFR of 55.3 mL/min.
Cotadutide demonstrated a dose-dependent reduction in urinary albumin-to-creatinine ratio, achieving statistical significance at doses of 300 μg and 600 μg.
Effects on urinary albumin-to-creatinine ratio were sustained up to week 26.
Safety and tolerability of cotadutide 600 μg were similar to that of semaglutide.
Findings suggest potential kidney protective benefits of cotadutide that require further investigation in larger studies.

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Cotadutide is a glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist that may improve kidney function in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). In this phase 2b study, patients with T2D and CKD (estimated glomerular filtration rate [eGFR] of 20 or more and under 90 mL/min per 1.73 mand urinary albumin-to-creatinine ratio [UACR] over 50 mg/g) were randomized 1:1:1:1:1 to 26 weeks' treatment with standard of care plus subcutaneous cotadutide uptitrated to 100, 300, or 600 μg, or placebo daily (double-blind), or the GLP-1 agonist semaglutide 1 mg once weekly (open-label).The co-primary endpoints were absolute and percentage change versus placebo in UACR from baseline to the end of week 14. Among 248 randomized patients, mean age 67.1 years, 19% were female, mean eGFR was 55.3 mL/min per 1.73 m, geometric mean was UACR 205.5 mg/g (coefficient of variation 270.0), and 46.8% were receiving concomitant sodium-glucose co-transporter 2 inhibitors. Cotadutide dose-dependently reduced UACR from baseline to the end of week 14, reaching significance at 300 μg (-43.9% [95% confidence interval -54.7 to -30.6]) and 600 μg (-49.9% [-59.3 to -38.4]) versus placebo; with effects sustained at week 26. Serious adverse events were balanced across arms. Safety and tolerability of cotadutide 600 μg were comparable to semaglutide. Thus, our study shows that in patients with T2D and CKD, cotadutide significantly reduced UACR on top of standard of care with an acceptable tolerability profile, suggesting kidney protective benefits that need confirmation in a larger study. 2 2

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A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease

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