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Search / Trial NCT07042672

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

Launched by HAUKELAND UNIVERSITY HOSPITAL · Jun 27, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This study is looking at how two different approaches affect people who have both obesity and binge eating disorder (BED), a condition where someone frequently eats large amounts of food and feels out of control. The researchers want to compare the effects and safety of a medicine called GLP-1 analogues—which can help reduce appetite—with not using any appetite-suppressing drugs. Everyone in the study will also take part in a lifestyle program that includes regular check-ins every four months and group therapy focused on changing eating habits and coping skills.

Adults between 18 and 65 years old who have severe obesity (a very high body weight that affects health) and diagnosed BED may be eligible. Participants will be split into two groups: one receiving the GLP-1 medicine and the other not using any appetite suppressants. Both groups will attend the same group therapy sessions and follow-up visits. Over the course of a year, the study will track changes in binge eating behaviors, mental health, use of other harmful coping methods, and weight. This research aims to find out which treatment helps best with binge eating and overall well-being in people struggling with obesity and BED.

Gender

ALL

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

About Haukeland University Hospital

Haukeland University Hospital, located in Bergen, Norway, is a leading academic medical center renowned for its commitment to innovative research and high-quality patient care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical fields to facilitate cutting-edge clinical studies that aim to advance healthcare outcomes. With a multidisciplinary team of healthcare professionals and researchers, Haukeland University Hospital fosters collaboration and knowledge exchange, ensuring that trials are conducted with the highest standards of ethics, safety, and scientific rigor. Its strategic focus on translational research enhances the bridge between laboratory discoveries and real-world applications, contributing to the global body of medical knowledge.

Locations

Bergen, Vestland, Norway

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported