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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Binge Eating Liraglutide Intervention

Short name BELIEVE

Overview

Status
Terminated
Phase
Phase 3
Enrollment
36 participants (actual)
Sponsor
Kelly Allison · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
29 Sept 2017
Primary completion
30 Sept 2019
Completion
1 Oct 2019
First posted
12 Sept 2017
Last update posted
24 Nov 2020
Conditions
Binge-Eating Disorder

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

    BELIEVE

    NCT03279731

    29 Sept 2017 to 1 Oct 2019

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study is a 17-week, single-center, double-blind, parallel-group, randomized placebo controlled trial that will test the efficacy of liraglutide 3.0 mg/d as compared to placebo in reducing the number of binge episodes per week, achieving remission from binge episodes, and in changes in body weight, global BED symptom improvement, cognitive restraint of food intake, dietary disinhibition, perceived hunger, quality of life, and depressed mood at treatment end.

Interventions

  • Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

    Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.

  • Placebo comparator

    Placebo

    Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Binge Episodes

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

    Registry description

    Change in objective binge episodes per week from randomization (week 0) to study end (week 17)

Secondary outcomes(3)
  1. Remission From Binge-eating

    Time frame · 13 to 17 weeks

    Registry description

    the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)

  2. Assessment of Improvement of Binge Eating Symptoms

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

    Registry description

    week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project \[prior to medication initiation\], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.

  3. Change in Body Weight

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

    Registry description

    changes in body weight

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline and 17 weeks (or last observation carried forward)

Binge Episodes

GroupValue (objective binge episodes per week)Spread
Liraglutide-3.970.56
Placebo-2.50.053
Secondary and other outcome results(3)
Secondary outcomeCount of participants· 13 to 17 weeks

Remission From Binge-eating

GroupValue (Participants)
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml3
Placebo4
Secondary outcomeMean· week 17 (or last observation carried forward)

Assessment of Improvement of Binge Eating Symptoms

GroupValue (units on a scale)Spread
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml1.52.27
Placebo1.93.26
Secondary outcomeMean· baseline and 17 weeks (or last observation carried forward)

Change in Body Weight

GroupValue (kg)Spread
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml-4.70.83
Placebo-0.940.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlPre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.0 / 192 / 1917 / 19
PlaceboPre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection0 / 171 / 1711 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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