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

What Was Tested

In this phase 1 trial, researchers set out to test Cotadutide.

It had three arms (groups): Arm 1 (experimental), Arm 2A (experimental) and Arm 2B (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male and female participants of age 18 to 55 years. Females must have a negative pregnancy test. Have a Body Mass Index (BMI) of ≥ 18 and ≤ 29.9 kg/m\^2.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: history of acute or chronic pancreatitis; history of neoplastic disease; current smokers or those who have smoked or used nicotine products (including e-cigarettes).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Cotadutide and who got the comparison, which limits bias.

The Cotadutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cotadutide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-01-03 with completion listed for 2023-03-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time-matched change-from-baseline Fridericia's correction of QT interval (QTcF) (time frame: Up to Day 92).

It also tracked 25 secondary outcomes, for example Change from baseline in QTcF, Change from baseline in Heart rate (HR), Change from baseline in PR interval, Change from baseline in QRS interval, Number of treatment-emergent changes in T-wave morphology and Number of treatment-emergent changes in U-waves presence.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cotadutide in 31 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cotadutide compound page, all human trials.