Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

What Was Tested

The trial (phase 3) is built around Liraglutide.

It had three arms (groups): Sleeve Gastrectomy Placebo (placebo comparator), Sleeve Gastrectomy Saxenda (active comparator) and RYGB (sham comparator).

Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.

Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.

The registry classes the interventions as drug and procedure.

More on the Plan

Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG).

The study team will play no role in assignment of the surgical procedure.

Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily.

Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months).

Who Took Part

The registry lists 46 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 20-65 years of age. No active physical illness which will interfere with mobility or weight loss after bariatric surgery. Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: prior use of glucose lowering medication in the 3 months prior to screening; prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy; pregnancy or active consideration of pregnancy during the period of study. subjects will be discontinued if they become pregnant during the study.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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, care provider and investigator.

It started in 2017-06-22 with completion listed for 2023-10-04.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Weight (time frame: baseline and 36 months).

It also tracked 3 secondary outcomes, for example Systolic Blood Pressure, Diastolic Blood Pressure and Low-density Lipoprotein (LDL).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 46 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.