Semaglutide [amount hidden] for Low Responders After Bariatric Surgery

What Was Tested

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

Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high.

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

Patients in this group will receive the placebo. This is a placebo which is distributed by an intramuscular injection once weekly.

The registry classes the interventions as drug and other.

More on the Plan

All these different fields have, as their cornerstone of treatment, lifestyle interventions.

All treatment options are adjunct to the lifestyle interventions.

Besides, not all overweight or obese people are eligible for all types of treatment.

These medications generally affect appetite and cause weight loss only when the agent is taken in adjunct to lifestyle modification.

Who Took Part

The registry lists 152 planned participants were the target.

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: BMI before surgery was ≥ 35.0 kg/m2. Patient is treated with group consultation at the NOK. Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG). Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: gastropareses or gastro-intestinal complaints after bariatric surgery; type 1 or type 2 diabetes and/or diabetic retinopathy; liver failure (all).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2024-05 with completion listed for 2026-02.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight change from start study at 3 months post operative until 15 months later (time frame: 15 months). Difference between placebo group and treatment group in weight change (time frame: 15 months).

It also tracked 53 secondary outcomes, for example Weight loss 3 months after surgery, Weight loss 6 months after surgery, Weight loss 12 months after surgery, Weight loss 18 months after surgery, Metabolic health before surgery (bloodpressure) and Metabolic health before surgery (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 152 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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