drugset / Trial / NCT03244800
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
RandomizedParallel-groupDouble-blindTreatment
Summary
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM). Approximately 63 subjects will be enrolled across two cohorts.
Timeline
- Start
- 2017-09-04
- Primary completion
- 2018-01-23
- Completion
- 2018-01-23
Publications
- Bosch R, Petrone M, Arends R, Sijbrands EJG, Hoefman S, Snelder N. From In Vitro Efficacy to Long-Term HbA1c Response for GLP-1R/GlucagonR Agonism Using the 4GI-HbA1c Systems Model. CPT Pharmacometrics Syst Pharmacol. 2025 Sep;14(9):1515-1525. doi: 10.1002/psp4.70074. Epub 2025 Jul 16.
- Parker VER, Robertson D, Wang T, Hornigold DC, Petrone M, Cooper AT, Posch MG, Heise T, Plum-Moerschel L, Schlichthaar H, Klaus B, Ambery PD, Meier JJ, Hirshberg B. Efficacy, Safety, and Mechanistic Insights of Cotadutide, a Dual Receptor Glucagon-Like Peptide-1 and Glucagon Agonist. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz047. doi: 10.1210/clinem/dgz047.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cotadutide | Peptide | 300 ug | Subcutaneous |