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
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
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
Single group
Semaglutide 3,2 mg/ml
DrugStarting 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.
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
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
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