Obesity & OverweightPhase 4SEM-BEATNCT07870538
A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
A Phase 4 study testing Semaglutide 3,2 mg/ml in people with Obesity & Overweight, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Semaglutide 3,2 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Aug 2026to Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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)
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity
Who cannot join
- Any form of diabetes mellitus (T1- or T2DM), defined as current hemoglobin A1c (HbA1c) > 6.5% or the use of antihyperglycemic drugs (metformin is permitted if prescribed for an indication other than T2DM and at a stable dose for at least 3 months days prior to screening)
- 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)
- Chronic kidney disease 3b or worse, defined as estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73m²
- Previous bariatric surgery
- Disorders known to affect DA signaling significantly, including movement disorders such as Parkinson's disease, prolactinoma, paraganglioma, pheochromocytoma
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- Active use of medication affecting DA signaling, including antiparkinson medications, attention deficit hyperactivity disorder (ADHD) medications, antipsychotics, naltrexone-bupropion for weight management or antidepressants; use of serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or trazodone is permitted if participants are on a stable dose for at least three months. Incidental use of antiemetics or sedative hypnotics is allowed but not within 48 hours prior to a study visit
- Current or recent (within the past 6 months) clinically significant alcohol or drug misuse (excluding nicotine) that, in the investigator's judgment, may compromise participant safety or the integrity of study data.
- Active severe neuropsychiatric disorders, including dementia, psychotic disorder, bipolar disorder and severe depression
- Acute suicidality or history of suicide attempt within 5 years prior to screening
- Any condition or major illness which, in the investigator's opinion, may jeopardise participant safety or compliance with the protocol
- Unable to understand the risks, realistic benefits and compliance requirements of each program
- Unwillingness to be informed about incidental findings that may be important for the participant's health
- Recent participation (< 30 days) or simultaneous participation in an interventional Trial with an investigational medicinal product (IMP) or device
- If applicable: Female who is pregnant, breast-feeding or intends to become pregnant in the following 6 months or is of childbearing potential and not using an adequate, highly effective contraceptive
- For PET scanning (subset n=64): exposure to a significant amount (> 1mSv) of ionizing radiation in other research studies within the last 12 months
- For MRI scanning: any condition that would interfere with MRI scanning (e.g., cochlear implant, metal fragments in the eyes, cardiac pacemaker, neural stimulator and metallic body inclusion or other metallic implants in the body which may interfere with MRI scanning)
- Claustrophobia or too much uneasiness in limited spaces (to tolerate confinement during scanning procedures)
- Severe back problems, interfering with lying in supine position in the scanner without movement for long durations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Obesity & Overweight
- Being tested
- Semaglutide 3,2 mg/ml
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 3,2 mg/mlDrug
Starting dose is 0.25 mg once a week, escalated every four weeks until the maximal dose of 2.4 mg per week or the highest tolerated dose is reached, which will be maintained until the end of the Trial.
Route of administration: subcutaneous in the abdomen, thigh or upper arm.
| Study group | Role | What they receive |
|---|---|---|
| To identify for whom semaglutide works best across the binge eating spectrum | Experimental | Semaglutide 3,2 mg/ml (Wegovy®) Receives: Drug: Semaglutide 3,2 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) after semaglutide treatment
Change in BMI between baseline and 6 months after initiation of semaglutide treatment, expressed in kg/m²
Measured: From enrollment to the end of treatment at 6 months
Change in Binge Eating Scale (BES) score after semaglutide treatment
Change in BES score between baseline and 6 months after initiation of semaglutide treatment. Score range: 0 to 46 points
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start26 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870538
- Sponsor's protocol ID
- S71869
- Other IDs
- 2026-526016-36
- Acronym
- SEM-BEAT
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No