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BELIEVE
TerminatedPhase 3Results postedBinge Eating Liraglutide Intervention
Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Liraglutide
Listed sites
1
Recruiting sites
—
Enrollment
36
actual
Study population
Feeding And Eating Disorders, Obesity / overweight
Key I/E criterion
•BMI 27-29.9
Primary endpoint
•Binge Episodes
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
Inclusion criteria
1. BMI > 30 kg/m2 or BMI ≥ 27 - 29.9 kg/m² in the presence of at least one weight-related comorbid condition, such as binge eating disorder, hypertension, or dyslipidemia. There is no upper BMI limit for this trial.
2. Age ≥ 21 years and ≤ 70 years
3. Meet full DSM 5 criteria for BED
1. Recurrent episodes of binge eating characterized by both consuming an abnormally large amount of food in a short period of time compared with what others might eat in the same amount of time under the same or similar circumstances and experiencing a loss of control over eating during the episode.
2. These episodes feature at least 3 of the following:
4. All races and ethnicities are included
5. Eligible female subjects will be:
6. Ability to provide informed consent before any trial-related activities
7. Subjects must:
Exclusion criteria
1. Pregnant or nursing, or plans to become pregnant in the next 6 months, or not using adequate contraceptive measures
2. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg)
4. Type 1 diabetes
5. Type 2 diabetes
6. A combination of fasting glucose ≥ 126 mg/dl, combined with an HbA1c >6.5, will be used to indicate the presence of diabetes, an exclusion criterion
7. Recent history of cardiovascular disease (e.g., myocardial infarction or stroke within the past 6 months), congestive heart failure, or heart block greater than first degree
8. Clinically significant hepatic or renal disease
9. Thyroid disease, not controlled
10. History of malignancy (except for non-melanoma skin cancer) in past 5 years
11. The presence of current anorexia nervosa or bulimia nervosa
12. Current major depressive episode, active suicidal ideation, or lifetime history of suicide attempts. We will exclude participants who have a Patient Health Questionnaire-9 (PHQ-9) [31] score > 15, or a score of > 1 on the suicidal ideation item, as well as any risk of suicidality as measured by a score of 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)[32].
13. Psychiatric hospitalization within the past 6 months
14. Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
15. Diagnosis current or past psychosis
16. Use in past 3 months of medications known to treat BED (such as lisdexamfetamine), induce significant weight loss (i.e., prescription weight loss medications), or induce weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
17. Currently receiving behavioral or pharmacological treatment for BED
18. Loss of ≥ 10 lb of body weight within the past 3 months
19. Known or suspected allergy to trial medication(s), excipients, or related products
20. Hypersensitivity to liraglutide or any product components
21. The receipt of any investigational drug within 6 months prior to this trial
22. Previous participation in this trial (e.g., randomized and failed to participate)
23. History of pancreatitis
24. History of gastrointestinal surgery (unless it was an adjustable gastric band that has been removed).
Endpoints (8)
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
2 endpointsChange in Body Weight
Time frame:baseline and 17 weeks (or last observation carried forward)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | -4.7 | — |
| Placebo | -0.94 | — |
Change in Body Weight
Time frame:baseline and 17 weeks (or last observation carried forward)
Body weight, absolute change (kg)
change from baseline, improvement
Patient-reported / QoL
2 endpointsAssessment of Improvement of Binge Eating Symptoms
Time frame:week 17 (or last observation carried forward)
PGI, change
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | 95% CI |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 1.52 | — |
| Placebo | 1.93 | — |
Assessment of Improvement of Binge Eating Symptoms
Time frame:week 17 (or last observation carried forward)
PGI, change
change from baseline, improvement
Other clinical outcomes
4 endpointsBinge Episodes
Time frame:baseline and 17 weeks (or last observation carried forward)
change from baseline, improvement
Posted result
| Group | Value (mean), objective binge episodes per week | 95% CI |
|---|---|---|
| Liraglutide | -3.97 | — |
| Placebo | -2.50 | — |
Binge Episodes
Time frame:baseline and 17 weeks (or last observation carried forward)
change from baseline, improvement
Remission From Binge-eating
Time frame:13 to 17 weeks
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 3 | — |
| Placebo | 4 | — |
Remission From Binge-eating
Time frame:13 to 17 weeks
threshold achievement, improvement
Publications (10)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Scientific reports2025 Aug 12PMID40796593doi:10.1038/s41598-025-12728-7via pubmed acronym asset candidate
- Vascular health and risk management2023 (year)PMID36647392doi:10.2147/VHRM.S396295via pubmed acronym asset candidate
- Frontiers in endocrinology2022 (year)PMID36733804doi:10.3389/fendo.2022.1061511via pubmed acronym asset candidate
- Frontiers in endocrinology2021 (year)PMID33841337doi:10.3389/fendo.2021.649018via pubmed acronym asset candidate
- Expert opinion on therapeutic patents2020 Oct (month)PMID32799587doi:10.1080/13543776.2020.1811851via pubmed acronym asset candidate
- Journal of inflammation (London, England)2019 (year)PMID31632200doi:10.1186/s12950-019-0225-zvia pubmed acronym asset candidate
- European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2016 Sep 20PMID27343696doi:10.1016/j.ejps.2016.06.018via pubmed acronym asset candidate
- International journal of clinical practice. Supplement2010 Oct (month)PMID20949698doi:10.1111/j.1742-1241.2010.02497.xvia pubmed acronym asset candidate
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.