A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
This study will be a randomized, double‐blind, placebo‐controlled 3‐arm parallel study with a nested crossover design for positive control with moxifloxacin administration in healthy male and female participants. Participants will be randomized to receive treatment with either cotadutide during the 13‐week treatment period (Arm 1) or cotadutide‐placebo (Arm 2). The cotadutide‐placebo treatment arm will be further divided into 2 subgroups (Arms 2A and 2B), in a nested crossover design for only the placebo‐treated participants. Participants will be randomized in a 2:1:1 ratio to Arm 1, Arm 2A, and Arm 2B. Approximately 80 participants will be randomized to have 64 evaluable participants in the study. Each participant will be involved in the study for approximately 22 weeks.
Epistemonikos ID: 0d0933d19369feddebb9cd883097975fede04a4c
First added on: Oct 02, 2023