A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum

What Was Tested

The trial (phase 4) is built around Semaglutide.

The goal of this clinical trial is to investigate how GLP-1 receptor analogs, such as semaglutide (Wegovy®), influence processes that determine eating behavior, binge eating, and weight regulation via the gut-brain axis.

The main question it aims to answer is: to identify for whom semaglutide works best.

Participants will: * undergo a semaglutide treatment for 6 months * visit the clinic for 2-4 study checkup and tests * wear a smartwatch and complete questionnaires on their smartphone.

It had 1 arm (groups): To identify for whom semaglutide works best across the binge eating spectrum (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 96 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. At least 18 years of age and under 65 years of age at the time of signing the informed consent form (ICF). BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: use of incretin-based drugs, including glp-1ras (including dual agonists) and dipeptidyl peptidase-4 (dpp-4) inhibitors or amylin analogues within 3 months prior to screening; contraindications for semaglutide: history of pancreatitis, medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men2); previous bariatric surgery.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-08-26 with completion listed for 2028-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Mass Index (BMI) after semaglutide treatment (time frame: From enrollment to the end of treatment at 6 months). Change in Binge Eating Scale (BES) score after semaglutide treatment (time frame: From enrollment to the end of treatment at 6 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 96 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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