Status:

RECRUITING

Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity

Lead Sponsor:

Haukeland University Hospital

Collaborating Sponsors:

University of Bergen

Conditions:

Binge Eating Disorder Associated With Obesity

Binge Eating Disorder

Eligibility:

All Genders

18-65 years

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 suppre...

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

Key Trial Info

Start Date :

July 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2028

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT07042672

Start Date

July 1 2025

End Date

December 31 2028

Last Update

September 15 2025

Active Locations (1)

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Haukeland University Hospital

Bergen, Vestland, Norway, 5021