Semaglutide for Weight Management in Adults with Obesity and Binge Eating: Identifying Who Benefits Most

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What is this study about?

The study focuses on adults with obesity who also experience binge eating. The medication being tested is a once‑weekly injection of semaglutide, which mimics the action of a natural gut hormone called GLP‑1 to reduce appetite and help control food intake.

The purpose of the study is to determine which individuals respond best to this therapy. Participants will receive the injection for about six months, during which their weight, measured by BMI, will be recorded at the start and after the treatment period. They will also complete a questionnaire called the Binge Eating Scale to see how their eating patterns change. Simple measurements such as the waist/hip ratio and a brief assessment of body composition will be taken to track where weight is lost.

Throughout the trial, blood samples and brief health checks will be used to look at things like hormone levels, feelings of hunger or fullness, heart rate, and blood pressure. These tests help researchers understand how the drug influences appetite, mood, and the body’s response to food without requiring any complex procedures.

1 baseline assessment

on the first day after joining, you will have a baseline assessment. this includes measuring your body mass index (bmi), waist and hip circumference, body composition, and completing the binge eating scale (bes) questionnaire. blood and urine samples will be collected to evaluate hormone levels, dopamine (da) levels, and other health indicators.

2 start medication

you will receive a pre‑filled pen containing semaglutide (brand name wegovy) at a dose of 2.4 mg. the medication is administered by a subcutaneous injection, which means the injection is given under the skin. the first injection is given under supervision, after which you will be instructed on how to give yourself the weekly injection.

3 weekly injections

you will self‑administer a 2.4 mg dose of semaglutide once every week for a total period of six months. each injection is given under the skin, typically in the abdomen, thigh, or upper arm. you should keep a record of the injection dates to maintain the weekly schedule.

4 regular study visits

approximately once a month, you will attend a study visit. during these visits, the research team will measure your weight, bmi, waist/hip ratio, and body composition. blood and urine samples may be taken again, and you will complete the bes questionnaire to track changes in binge‑eating behavior. any side effects or concerns will be reviewed.

5 six‑month assessment

at the end of six months of treatment, a comprehensive assessment identical to the baseline assessment will be performed. the same measurements—bmi, waist/hip ratio, body composition, blood and urine tests, and the bes questionnaire—will be repeated to evaluate changes.

6 trial completion

after the six‑month assessment, the study medication phase ends. final data are collected, and no further injections of semaglutide are required as part of the trial.

Who Can Join the Study?

You must sign a written informed consent form, which means you understand the study and agree to join voluntarily.
You must be at least 18 years old but younger than 65 years old when you sign the consent form.
You must use a highly effective birth control method (fails less than 1% per year) such as implants, injectables, combined oral contraceptives, certain IUD devices, complete abstinence from heterosexual intercourse, or have a partner who is vasectomised.
Your BMI (body mass index, measured in kilograms per square meter) must be 30 kg/m² or higher, or at least 27 kg/m² if you have at least one weight‑related comorbidity (a health problem linked to excess weight, such as high blood pressure or diabetes).

Who Cannot Join the Study?

Having any type of diabetes mellitus (type 1 or type 2), which means a blood‑sugar test called HbA1c higher than 6.5% or using medicines to lower blood sugar (except metformin taken for a different reason and stable for at least 3 months).
Feeling an urgent desire to kill yourself or having tried to kill yourself within the past 5 years.
Having any other serious illness that the doctor thinks could put your safety at risk or make it hard to follow the study rules.
Not being able to understand the possible risks, realistic benefits, and what you would need to do in the study.
Not wanting to be told about unexpected health findings that might be important for you.
Having taken part in another experimental drug or device study, or using an investigational product, within the last 30 days.
If you are a woman who is pregnant, breast‑feeding, plans to become pregnant in the next 6 months, or could become pregnant and is not using a reliable, highly effective birth‑control method.
For the small group that will have a PET scan: having received a large amount (more than 1 millisievert) of ionizing radiation in other research studies in the past 12 months. (Ionizing radiation is a type of energy that can affect cells.)
For MRI scanning: having any condition that would interfere with the scan, such as a cochlear implant, metal fragments in the eyes, a heart pacemaker, a neural stimulator, or any other metal implants that could be affected by the magnetic field.
Having severe claustrophobia or feeling extremely uncomfortable in small, enclosed spaces, which would make it hard to stay still in the scanner.
Having serious back problems that prevent you from lying flat on your back without moving for a long time.
Using any incretin‑based medicines (including GLP‑1 receptor agonists, dual agonists, DPP‑4 inhibitors, or amylin analogues) within the past 3 months.
Having a medical history that makes semaglutide unsafe, such as past pancreatitis (inflammation of the pancreas), medullary thyroid carcinoma (a type of thyroid cancer), or multiple endocrine neoplasia type 2 (MEN2, a genetic condition that can cause tumors).
Having chronic kidney disease stage 3b or worse, defined as an estimated glomerular filtration rate (eGFR) lower than 45 ml/min/1.73 m². (eGFR measures how well the kidneys filter blood.)
Having had bariatric (weight‑loss) surgery in the past.
Having disorders that strongly affect dopamine (DA) signaling, such as Parkinson’s disease, prolactinoma, paraganglioma, or pheochromocytoma.
Currently using medications that affect dopamine signaling, including medicines for Parkinson’s disease, ADHD, antipsychotics, or weight‑loss drugs like naltrexone‑bupropion, as well as most antidepressants. (Stable use of SSRIs, SNRIs, or trazodone for at least 3 months is allowed; occasional anti‑nausea or sleep medicines are allowed if not taken within 48 hours before a study visit.)
Having a current or recent (within the past 6 months) significant problem with alcohol or drug misuse (excluding nicotine) that the doctor believes could affect your safety or the study results.
Having an active severe neuropsychiatric disorder, such as dementia, a psychotic disorder, bipolar disorder, or severe depression.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.07.2026

Trial locations

Investigated drugs:

Semaglutide

Wegovy is an injectable medicine that contains semaglutide, a compound that works like a natural hormone in the body to help control appetite. In this study, participants receive Wegovy under the skin to see how well it helps them lose weight and manage binge‑eating behaviors. The goal is to find out which types of patients respond best to this medication, so doctors can choose the right people for this type of weight‑management treatment.

Obesity – Obesity is a condition where excess body fat builds up to a level that may affect health. It usually develops gradually as the amount of food consumed consistently exceeds the amount burned for energy. Over time, the extra weight can increase waist size, alter body composition, and make it harder to feel full after eating. The condition often progresses with stronger cravings and a reduced sense of satiety. As more fat is stored, the body’s hormone signals that control hunger and metabolism may change.

Trial ID:

2026-526016-36-00

Protocol code:

SEM-BEAT

Trial Phase:

Therapeutic confirmatory (Phase III)

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Semaglutide for Weight Management in Adults with Obesity and Binge Eating: Identifying Who Benefits Most

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