Binge Eating Liraglutide Intervention (BELIEVE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml; Drug: Placebo

Detailed Description

All applicants will be initially screened by phone and/or electronically to determine whether they potentially meet eligibility criteria. Those who appear to meet eligibility criteria and remain interested in the trial will be scheduled for an in-person interview.

The in-person interview will be conducted by a psychologist or Masters' level staff member, who will obtain informed consent and evaluate subjects' behavioral eligibility (i.e., willingness and appropriateness to participate) using structured and semi-structured clinical interviews including: an examination of the applicants' BED symptoms, their mood, suicidality, and other general psychopathology. Participants will also be asked to complete questionnaires assessing eating behavior, demographic characteristics, frequency of specific eating behaviors related to loss of control, risk of substance dependence with the consumption of high fat/sugar foods, alexithymia, night eating syndrome, sleep patterns and quality, and attitudes towards food cravings.

Subjects who remain interested and pass this portion of the assessment will proceed to meet with the study physician or nurse practitioner, who will obtain a medical history and conduct a physical examination to determine medical eligibility. Subjects will also have an electrocardiogram (EKG), fasting blood test, and a urine pregnancy test (for females of child bearing age) to confirm eligibility.

Upon successful completion of the screening visit, subjects will be asked to eat as they normally would for 2 weeks. Once per week over these two weeks they will receive a brief survey through REDcap to assess their binge eating episodes for eligibility.

Subjects who continue to meet eligibility criteria assessed at the screening visit and during the run-in period will be scheduled for a randomization visit at the Center within 3 weeks of their screening.

Subjects will be randomly assigned to the two interventions in equal numbers (i.e., 1:1 ratio). The subject's weight, blood pressure, and pulse will then be measured. Following randomization, all subjects will have a medical visit with the study physician or nurse practitioner who will instruct them in the use of liraglutide 3.0 (as described later) and provide the first month's supply of medication.

After randomization, subjects will return at week 1 to assess rate of response. Subjects will return for study visits every two weeks thereafter, at weeks 3, 5, 7, 9, 11, 13, 15, and 17.

These study visits include a brief medical visit (10-15 minutes) with a physician or nurse practitioner to monitor their response to the medication or any changes in health. Vitals and weight will be taken. Additionally, binge episodes, mood, suicidality, and symptom improvement will be assessed by the psychologist or Masters' level trained study staff. Participants will be asked also to complete questionnaires assessing quality of life, obsessions related to food, and food cravings prior to each treatment visit for the secondary outcomes:

In summary, study visits will consist of the medical visit, completion of written surveys, review of structured interviews with the study staff and review of medication adverse events. These visits are expected to last about 30-40 minutes. The study assessments at week 17 will consist of the previously listed procedures and measures in addition to the questionnaires and blood tests conducted at baseline.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • University of Pennyslvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.
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.	Drug: 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 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Episodes	Change in objective binge episodes per week from randomization (week 0) to study end (week 17)	baseline and 17 weeks (or last observation carried forward)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission From Binge-eating	the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)	13 to 17 weeks
Assessment of Improvement of Binge Eating Symptoms	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.	week 17 (or last observation carried forward)
Change in Body Weight	changes in body weight	baseline and 17 weeks (or last observation carried forward)

Collaborators and Investigators

• Sponsor: Kelly Allison
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Kelly C Allison, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 9, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: eating disorder, pharmacotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 827450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No