Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher

What Was Tested

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

Patients with BMI 60 kg/m² or higher are the hardest operations in bariatric surgery.

Every bariatric surgeon knows this group.

It had two arms (groups): GLP 1 (active comparator) and Placebo (placebo comparator).

Matched placebo pens on the identical schedule.

The registry classes the interventions as drug.

More on the Plan

Operative difficulty can be measured properly.

The surgeon cannot be blinded to the patient's habitus on the table; the raters watching the video are blinded to allocation.

This gives a blinded, objective primary endpoint in an unblindable operation.

Perioperative drug handling follows the 2025 multisociety guidance: last injection at least 7 days before surgery, 24 hours of clear fluids, and full-stomach precautions at induction (PMID 39480373).

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: BMI 60 kg/m² or higher at first surgical assessment. Accepted by the multidisciplinary team for primary laparoscopic SG or RYGB. Able to self-inject and consent.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: any previous bariatric or major upper abdominal surgery; GLP-1-based therapy within the previous 6 months; type 1 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and care provider.

It started in 2026-10 with completion listed for 2028-11.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean operative difficulty score (time frame: At the time or during surgery).

It also tracked 11 secondary outcomes, for example Preoperative percentage of total weight loss (%TWL), Operative time, skin to skin, Estimated blood loss, Intraoperative adverse events, Conversion to open and Number of stapler loads.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 100 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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