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BETTER-GLP1
RecruitingBehavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity
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
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Liraglutide / Semaglutide / Tirzepatide
Listed sites
1
Recruiting sites
1
Enrollment
80
estimated
Study population
Feeding And Eating Disorders, Obesity / overweight
Key I/E criterion
•BMI ≥40
Primary endpoint
•EDE-Q Global Score
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
Patients with obesity and binge eating disorder. The study will enroll patients with concomitant severe obesity and BED who are referred to the Obesity clinic at Haukeland University Hospital, Norway. All potentially eligible participants will be routinely screened for BED and EDE interview (gold standard) will be used to formally diagnose BED according to the DSM-5.
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
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointMean Difference in Change in Body Weight and BMI Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsMean Difference in Change in Systolic and Diastolic Blood Pressure Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Mean Difference in Change in Biochemical Markers of Metabolic Disease Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Patient-reported / QoL
7 endpointsChange in EDE-Q Global Score From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Qualitative Evaluation of Patient Experiences With Combined CBT and GLP-1 Treatment
Time frame:12 months
descriptive
Mean Difference in Change in DSHI Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Mean Difference in Change in DERS Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Mean Difference in Change in BDI-II Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Mean Difference in Change in BAI Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Mean Difference in Change in CIA Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
change from baseline, improvement
Other clinical outcomes
3 endpointsProportion of Participants With Increase in Composite Harmful Coping Endpoint (CHCE) From Baseline to 12 Months
Time frame:Baseline and 12 months
threshold achievement, event
componentsdeliberate self harm, AUDIT score, drug misuse dudit threshold
Mean Difference in Change in AUDIT Score Between Groups From Baseline to 12 Months
Time frame:From baseline to 12 months
AUDIT score
change from baseline, improvement
Mean Difference in Change in DUDIT Score Between Groups From Baseline to 12 Months
Time frame:Baseline and 12 months
AUDIT score
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.