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Semaglutide for weight management in adults with obesity and binge‑eating: a study to identify who benefits

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Obesity is a condition in which a person carries excess body weight that can affect health, and many people with obesity also experience episodes of uncontrolled eating, known as binge eating. The study examines a medication called semaglutide, which works through a hormone pathway called GLP-1. This medicine is given as a small subcutaneous injection (a shot under the skin) and is intended to help reduce weight and control eating habits.

The main goal of the research is to find out which individuals respond best to the treatment. Participants will receive the medication for about six months, with visits at the beginning and end of the period to collect information on weight, eating behavior, and other health measures.

Key outcomes include changes in BMI (a number that compares weight to height), changes in the Binge Eating Scale (a questionnaire that measures the severity of binge eating), as well as waist‑to‑hip ratio, body composition, appetite feelings, and various blood markers. Simple explanations are provided for any technical terms, such as BMI being a standard way doctors assess whether weight is in a healthy range.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and initial briefing
After signing the consent form, receive written information about the study procedures.
Receive training on how to use the pre‑filled pen for the subcutaneous injection of wegovy 2.4 mg.
Step 2
Baseline assessments
Measure body weight, height and calculate body mass index (bmi).
Complete the binge eating scale (bes) questionnaire.
Provide blood and urine samples for laboratory analysis of hormone levels, dopamine, cytokines and other markers.
Record waist and hip measurements, blood pressure, heart rate and other vital signs.
Step 3
First dose of medication
Receive the first wegovy 2.4 mg dose administered as a subcutaneous injection using the pre‑filled pen.
Follow the injection technique demonstrated during the training session.
Step 4
Ongoing medication period
Continue receiving wegovy 2.4 mg injections according to the study schedule for approximately six months.
Attend scheduled clinic visits for safety checks, collection of additional blood or urine samples, and monitoring of weight, bmi and binge eating scale as instructed.
Step 5
Six‑month assessment
Repeat the measurements performed at baseline, including body weight, bmi, waist/hip ratio, body composition and binge eating scale.
Provide follow‑up blood and urine samples for the same laboratory analyses conducted at baseline.
Record any changes in appetite, food cravings, emotional state, heart rate, blood pressure and other study endpoints.
Step 6
Study completion
Attend a final visit to discuss the overall results of the study measurements.
Receive instructions regarding discontinuation of the study medication and any further follow‑up that may be recommended.

Who can join the trial?

4 criteria

You must sign a voluntary written informed consent form, which shows you agree to join the study after understanding what it involves.
You must be at least 18 years old but younger than 65 years old when you sign the consent form.
You need to use a highly effective method of birth control (such as implants, injections, combined oral contraceptive pills, certain IUDs, complete abstinence, or have a partner who has had a vasectomy) to prevent pregnancy during the trial.
Your body‑mass index (BMI) must be 30 kg/m² or higher, or at least 27 kg/m² if you have at least one weight‑related comorbidity (another health problem caused by excess weight).

Who cannot join the trial?

19 criteria

Diabetes mellitus (type 1 or type 2) – any form of diabetes, shown by a blood test called HbA1c higher than 6.5% or by using blood‑sugar medicines (metformin is allowed only if taken for another reason and at a stable dose for at least 3 months).
Acute suicidality or a suicide attempt within the past 5 years.
Any serious illness that the doctor believes could put you at risk or make it hard to follow the study rules.
Inability to understand the risks, realistic benefits, and what is required to take part in the study.
Unwillingness to be informed about unexpected health findings that might be important for you.
Participation in another drug or device trial, or starting one, 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 are not using a highly effective birth‑control method.
For the PET scan portion: having received a high amount of radiation (> 1 mSv) from other research studies in the past year.
For the MRI scan portion: having any implant or metal that could be unsafe in an MRI (e.g., cochlear implant, metal fragments in the eyes, heart pacemaker, neural stimulator, or other metal devices).
Severe claustrophobia or extreme discomfort in small, enclosed spaces.
Serious back problems that prevent you from lying flat on your back without moving for a long time.
Use of incretin‑based drugs (including GLP‑1 receptor agonists, dual agonists, DPP‑4 inhibitors, or amylin analogues) within the past 3 months.
History of conditions that are a contraindication for semaglutide: past pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN2).
Having chronic kidney disease stage 3b or worse, defined by an estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73 m² (a test that measures kidney function).
Previous bariatric (weight‑loss) surgery.
Disorders that significantly affect dopamine (DA) signaling, such as Parkinson’s disease, prolactinoma, paraganglioma, or pheochromocytoma.
Active use of medications that affect dopamine signaling, including Parkinson’s medicines, ADHD medicines, antipsychotics, naltrexone‑bupropion for weight management, or antidepressants (stable dose for at least 3 months). Occasional anti‑nausea or sleep medicines are allowed except within 48 hours before a study visit.
Current or recent (within the past 6 months) significant alcohol or drug misuse (excluding nicotine) that the doctor believes could compromise safety or study data.
Active severe neuropsychiatric disorders, such as dementia, psychotic disorder, bipolar disorder, or severe depression.

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Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

Wegovy is a medication that contains the active ingredient semaglutide. It is given as a small injection under the skin. In this study, Wegovy is being tested to see how well it helps people lose weight, especially those who have problems with binge eating. Researchers want to find out which patients get the biggest benefit from this drug.

Semaglutide

What is already known about the treatment

Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen - It is administered as a subcutaneous injection using a ready‑to‑use pre‑filled pen that delivers 2.4 mg of semaglutide in liquid form. Semaglutide is an approved drug in many countries for chronic weight management and type 2 diabetes and is well documented in medical literature. It works by acting like the body’s own GLP‑1 hormone, which signals fullness to the brain, helping to lower appetite and food intake. The medication belongs to the GLP‑1 receptor agonist class.

Investigated diseases

Obesity - Obesity is a condition characterized by excess body fat that accumulates to a level that may affect health. It usually develops gradually as a result of consuming more calories than the body uses. Over time, the extra fat can increase the size of the abdomen and other body parts. The condition often leads to a higher body mass index (BMI) and can become more pronounced without changes in diet or activity. As weight continues to increase, the individual may notice changes in waist and hip measurements and a shift in body composition. The progression can vary, but the amount of stored fat tends to rise steadily if the underlying pattern persists.