Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects

What Was Tested

The trial (phase 1) is built around Liraglutide.

This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.

It had two arms (groups): Active (experimental) and Placebo (placebo comparator).

Liraglutide.

Placebo comparator.

The registry classes the interventions as drug and other.

Who Took Part

61 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and female subjects;. Body Mass Index 30-40 kg/m2;.

The full record lists 2 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group 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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-02-20 with completion listed for 2018-01-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5 (time frame: Visit 3, Visit 4 and Visit 5).

It also tracked 8 secondary outcomes, for example Number of Participants With Vital Signs Data Meeting Categorical Criteria, Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Number of Participants With Abnormal 12-lead Electrocardiogram (ECG), Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) and Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 61 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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