A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Cohort 1 vs MEDI0382 Cohort 1; p <0.001; ANCOVA NCT03244800 ↗

registry analysis (superiority test); Placebo Cohort 1 vs MEDI0382 Cohort 1; p = 0.002; ANCOVA NCT03244800 ↗

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

Indications