Last updated on February 2020

Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus

Brief description of study

This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.

Detailed Study Description

This is a randomized, blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9 days and an up to 7-week up-titration treatment period followed by a 3-week treatment extension period (if applicable), followed by a 28-day follow-up period.

Clinical Study Identifier: NCT04208620

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Research Site

Suita-shi, Japan
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