← Trials/Trial dossier/NCT03279731

BELIEVE

TerminatedPhase 3Results posted

Binge Eating Liraglutide Intervention

Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder

Lead sponsor

Kelly Allison

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

NCT IDNCT03279731
Org study ID827450

Timeline

Milestones

Study first posted2017-09-12actual
Study start2017-09-29actual
Primary completion2019-09-30actual
Study completion2019-10-01actual
Last update posted2020-11-24actual
Results first posted2020-11-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Feeding And Eating DisordersObesity / overweight

Eligibility

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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:

i.consuming food more rapidly than normal;
ii.eating until uncomfortably full;
iii.consuming large amounts of food when not hungry;
iv.consuming food alone due to embarrassment;
v.feeling disgusted, depressed, or guilty after eating a large amount of food. c. Significant distress about the binge episodes is present. d. Binge episodes must occur, on average, at least once per week for 3 months.

4. All races and ethnicities are included

5. Eligible female subjects will be:

non-pregnant, evidenced by a negative urine dipstick pregnancy test
non-lactating
surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study

6. Ability to provide informed consent before any trial-related activities

7. Subjects must:

have a primary care provider (PCP) who is responsible for providing routine care
have reliable telephone or Internet service to communicate with study staff
understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
plan to remain in the Philadelphia area for the next 6 months or more

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

Other clinical outcomes
4
Weight & body composition
2
Patient-reported / QoL
2

Weight & body composition

2 endpoints
Secondary/registry result

Change 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

GroupValue (mean), kg95% CI
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml-4.7
Placebo-0.94
Secondary/protocol endpoint

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 endpoints
Secondary/registry result

Assessment of Improvement of Binge Eating Symptoms

Time frame:week 17 (or last observation carried forward)

PGI, change

change from baseline, improvement

Posted result

GroupValue (mean), units on a scale95% CI
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml1.52
Placebo1.93
Secondary/protocol endpoint

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 endpoints
Primary/registry result

Binge Episodes

Time frame:baseline and 17 weeks (or last observation carried forward)

change from baseline, improvement

Posted result

GroupValue (mean), objective binge episodes per week95% CI
Liraglutide-3.97
Placebo-2.50
Primary/protocol endpoint

Binge Episodes

Time frame:baseline and 17 weeks (or last observation carried forward)

change from baseline, improvement

Secondary/registry result

Remission From Binge-eating

Time frame:13 to 17 weeks

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml3
Placebo4
Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.