A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects

What Was Tested

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

This trial is conducted in Europe.

The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.

It had three arms (groups): Arm 1: semaglutide + moxifloxacin placebo (experimental), Arm 2A: (active comparator) and Arm 2B: (experimental).

Semaglutide placebo + moxifloxacin/moxifloxacin placebo: Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment.

Semaglutide placebo + moxifloxacin placebo/moxifloxacin: Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment.

The registry classes the interventions as drug.

Who Took Part

The registry lists 168 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: BMI (Body Mass Index): 20-30 kg/m\^2. Body weight: 60-110 kg. Normal ECG (electrocardiogram).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of seizures, epilepsy, syncope, cardiac arrest, cardiac arrhythmia or torsades de pointes, a-v (atrioventricular) block or structural heart disease; smoking, drug or alcohol abuse.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-02-26 with completion listed for 2015-04-23.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points.

It also tracked 1 secondary outcome, for example QTcI, based on ECG (electrocardiogram) recordings obtained at 2 out of 8 time points.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 168 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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