Behavioral therapy plus GLP-1 medicines for binge eating and weight in people with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized observational study comparing patients who use GLP-1 analogues with patients who do not while both receive a lifestyle program and 10 weeks of CBT-E group therapy plus individual consultations. About 80 adults with severe obesity and DSM-5 binge eating disorder at Haukeland University Hospital will be followed over time and divided into Group-GLP1 and Group-NoMED. The primary focus is on changes in binge eating symptoms, with secondary evaluations of adoption of harmful coping behaviors, psychological well-being, weight change, and effects on obesity-related comorbidities. Safety and tolerability of GLP-1 use in this population will also be recorded.

Why it matters

Who can join: the full rules

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

Where it's running

• Haukeland University Hospital
  Bergen, Vestland, Norway Recruiting

Study contacts

• Study coordinator: Malin M Kleppe, PhD candidate
• Email: malin.mandelid.kleppe@helse-bergen.no
• Phone: +47 99357771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.