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
- Are there results?
- Not yet: the study is under way
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
Show all 19Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
- ClinicalTrials.gov ID
- NCT07870538
- Acronym / sponsor ID
- SEM-BEAT / S71869
- Conditions
- Obesity & Overweight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To identify for whom semaglutide works best across the binge eating spectrum | Experimental | Drug: Semaglutide 3,2 mg/mlSemaglutide 3,2 mg/ml (Wegovy®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 3,2 mg/mlStarting 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. | Drug | To identify for whom semaglutide works best across the binge eating spectrum |
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 BMI between baseline and 6 months after initiation of semaglutide treatment, expressed in kg/m²
Change in Binge Eating Scale (BES) score after semaglutide treatment
Time frame: From enrollment to the end of treatment at 6 months
Change in BES score between baseline and 6 months after initiation of semaglutide treatment. Score range: 0 to 46 points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman Vangoitsenhoven, Prof. Dr. (+3216193235, roman.vangoitsenhoven@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) after semaglutide treatment (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.