The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

This trial is conducted in Europe.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.

It had six arms (groups): one (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 564 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: obesity induced by drug treatment; use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial; type 1 or type 2 diabetes.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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 Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2007-01-10 with completion listed for 2007-09-13.

It ran at 19 sites in Spain (4), Denmark (3), Finland (3), United Kingdom (3), Czechia (2) and Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Change From Baseline in Body Weight at Week 20 (time frame: Week 0, week 20).

It also tracked 19 secondary outcomes, for example Mean Change From Baseline in Body Weight at Week 104, Change From Baseline in Fasting Plasma Glucose at Week 20, Change From Baseline in Fasting Plasma Glucose at Week 104, Change From Baseline in Fasting Insulin at Week 20, Change From Baseline in Fasting Insulin at Week 104 and Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 564 people.

With 564 participants it is a large trial for this field.

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.