Effect of Liraglutide on Heart Frequency in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in the United States of America (USA).

The aim of this trial is to investigate if liraglutide effects the QTc interval.

Moxifloxacin (Avelox®) is administered as positive control.

It had four arms (groups): Double-blind / liraglutide (experimental), Double-blind / placebo (placebo comparator), Open-label / moxifloxacin (active comparator) and Open-label / placebo (placebo comparator).

The registry classes the interventions as drug and procedure.

Who Took Part

64 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): 20.0-29.0 kg/m\^2 (inclusive). Heart rate within the range of 50-90 beats per minute (inclusive). Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: T-wave abnormalities; individual or familial history of long qt syndrome; positive results on screening for hepatitis b surface antigen, hepatitis c antibody or hiv (human immunodeficiency virus) antibody.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-07 with completion listed for 2006-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum time-matched mean difference between the baseline subtracted QTci intervals.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 64 people.

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

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