Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide for fat loss, obesity & body recomposition.

This trial is conducted in North America.

The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

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

The registry classes the interventions as drug.

Who Took Part

422 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 with presence of co-morbidities. Stable body weight during the previous 3 months (less than 5 kg self-reported weight change).

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: diagnosis of type 1 or type 2 diabetes; previous treatment with glp-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months; visit 1 thryoid stimulating hormone (tsh) outside of the range of 0.4-6.0 miu/l.

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 fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2008-10-30 with completion listed for 2010-09-01.

It ran at 37 sites in United States (27) and Canada (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Percentage Change in Fasting Body Weight From Baseline (time frame: Week 0, week 56). Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 (time frame: Week 0, week 56).

It also tracked 23 secondary outcomes, for example Change From Baseline in Fasting Weight, Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period, Change From Baseline in Blood Pressure, Change From Baseline in Pulse, Change From Baseline in Fasting Lipid Profile: Triglycerides and Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 422 people with fat loss, obesity & body recomposition.

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

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.