drugset / Trial / NCT04515849
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.
Timeline
- Start
- 2020-08-31
- Primary completion
- 2022-03-08
- Completion
- 2022-03-08
Publications
- Results Selvarajah V, Robertson D, Hansen L, Jermutus L, Smith K, Coggi A, Sanchez J, Chang YT, Yu H, Parkinson J, Khan A, Chung HS, Hess S, Dumas R, Duck T, Jolly S, Elliott TG, Baker J, Lecube A, Derwahl KM, Scott R, Morales C, Peters C, Goldenberg R, Parker VER, Heerspink HJL; study investigators. 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. Kidney Int. 2024 Dec;106(6):1170-1180. doi: 10.1016/j.kint.2024.08.023. Epub 2024 Aug 31.
- Yu H, Parker V, Selvarajah V, Hansen L, Robertson D, Hamren B, Khan A, Parkinson J. Pharmacokinetic-pharmacodynamic (PK/PD) modelling of cotadutide effect in patients with chronic kidney disease and type 2 diabetes mellitus. Br J Clin Pharmacol. 2025 Sep;91(9):2672-2683. doi: 10.1002/bcp.70093. Epub 2025 May 9.
- Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cotadutide | Peptide | 100 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 300 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 600 ug | Subcutaneous |
| Comparator | Semaglutide | Peptide | 1 mg | Subcutaneous |