Compares behavioral therapy with and without GLP-1 drugs for binge eating and obesity
Compares GLP-1 drugs with no appetite drugs in adults with obesity and binge eating.
Plain-language title generated from the registry record
Registry title: Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity
Key facts
- Where
- Bergen, NorwaySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07042672, who can take part
Where in Norway
- Haukeland University HospitalBergen, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haukeland University Hospital
- Trial code
- NCT07042672
- Record updated
- 15 September 2025
- Original description
This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED.Read full original descriptionShow less
Behavioral Therapy With and Without GLP-1 Analogue in Patients With Morbid Obesity and Binge Eating Disorder: A Clinical Prospective Observational Study on Body Weight, Binge Eating Behavior, and Harmful Coping Strategies
This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED.
The primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions.
Adult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions.
Changes in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.
Inclusion: Severe obesity defined as BMI >40 kg/m2 or 35 kg/m2 with obesity-related comorbidities: coronary artery disease, heart failure, hypertension, atrial fibrillation, cerebral stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes mellitus, non-alcoholic fatty liver disease, dyslipidemia, osteoarthritis and polecystic ovary syndrome; Age between 18 to 65 years; Diagnosis of BED according to DSM-5 criteria; Willingness to participate and provide informed consent; Able to understand and communicate in Norwegian.
Exclusion: Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication); Previous medullary thyroid cancer; Previous pancreatitis; Active substance abuse (but previous drug abuse accepted); Any illness or prior treatment that in the opinion of the investigator would jeopardize the patient's participation in the study or impact integrity and/or quality of study data; Previous bariatric surgery; Use of appetite suppressing drugs (e.g., GLP-1 analogues and/or naltrexone/bupropion) within the last 6 months; Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion; Renal failure with estimated glomerular filtration rate less than 30 mL/min/1,73m2; Liver failure with either ASAT and/or ALAT 5 times upper reference limit, or ALP and/or GT more than 3 times upper reference limit, or clinical signs of liver decompensation; Active cancer; Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months; Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program; Pregnant or lactating women, as well as women planning pregnancy within one year.