NCT07042672 Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity
| NCT ID | NCT07042672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Binge Eating Disorder Associated With Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-07-01 with a primary completion date of 2027-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria 1. 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 2. Age between 18 to 65 years 3. Diagnosis of BED according to DSM-5 criteria 4. Willingness to participate and provide informed consent 5. Able to understand and communicate in Norwegian Exclusion criteria 1. Pregnant or lactating women, as well as women planning pregnancy within one year. 2. Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication) 3. Renal failure with estimated glomerular filtration rate less than 30 mL/min/1,73m2 4. 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 5. Active cancer 6. Previous medullary thyroid cancer 7. Previous pancreatitis 8. Active substance abuse (but previous drug abuse accepted) 9. Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months. 10. Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program 11. 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. 12. Previous bariatric surgery 13. Use of appetite suppressing drugs (e.g., GLP-1 analogues and/or naltrexone/bupropion) within the last 6 months 14. Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07042672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Binge Eating Disorder Associated With Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042672 currently recruiting?
Yes, NCT07042672 is actively recruiting participants. Contact the research team at malin.mandelid.kleppe@helse-bergen.no for enrollment information.
Where is the NCT07042672 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT07042672 clinical trial?
NCT07042672 is sponsored by Haukeland University Hospital. The trial plans to enroll 80 participants.
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