Clinical Efficacy and Safety of Using [amount hidden] Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain.

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

The registry classes the interventions as drug.

Who Took Part

132 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: ≥18 months status-post RYGB. BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition. BMI 30 kg/m2 or greater. Ability to provide informed consent before any trial-related activities. Express willingness to follow protocol requirements.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: pregnancy at time of enrollment; intention of becoming pregnant or breast feeding in the next 12 months; females of childbearing potential who are not using adequate contraceptive methods.

How the Study Was Run

The set-up was 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.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2017-05-22 with completion listed for 2021-03-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 132 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.