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Binge Eating Liraglutide Intervention (BELIEVE)

Primary Purpose

Binge-Eating Disorder

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring eating disorder, pharmacotherapy

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Age ≥ 21 years and ≤ 70 years
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.
All races and ethnicities are included
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
Ability to provide informed consent before any trial-related activities
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:

Pregnant or nursing, or plans to become pregnant in the next 6 months, or not using adequate contraceptive measures
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg)
Type 1 diabetes
Type 2 diabetes
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
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
Clinically significant hepatic or renal disease
Thyroid disease, not controlled
History of malignancy (except for non-melanoma skin cancer) in past 5 years
The presence of current anorexia nervosa or bulimia nervosa
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].
Psychiatric hospitalization within the past 6 months
Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
Diagnosis current or past psychosis
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)
Currently receiving behavioral or pharmacological treatment for BED
Loss of ≥ 10 lb of body weight within the past 3 months
Known or suspected allergy to trial medication(s), excipients, or related products
Hypersensitivity to liraglutide or any product components
The receipt of any investigational drug within 6 months prior to this trial
Previous participation in this trial (e.g., randomized and failed to participate)
History of pancreatitis
History of gastrointestinal surgery (unless it was an adjustable gastric band that has been removed).

Sites / Locations

University of Pennyslvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Binge Episodes

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

Secondary Outcome Measures

Remission From Binge-eating

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

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.

Change in Body Weight

changes in body weight

Full Information

NCT ID

NCT03279731

First Posted

September 6, 2017

Last Updated

November 2, 2020

Sponsor

Kelly Allison

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03279731

Brief Title

Binge Eating Liraglutide Intervention

Acronym

BELIEVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

The study was not meeting recruitment goals.

Study Start Date

September 29, 2017 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kelly Allison

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge-Eating Disorder

Keywords

eating disorder, pharmacotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Single-center, double-blind, randomized placebo-controlled trial with parallel groups.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Novo Nordisk's Clinical Services (CS) will label, package, and ship the labelled study drugs to the Penn's Investigational Drug Service (IDS). Dr. Rockwell from Penn's IDS service will generate the randomization code using a 1:1 randomization scheme of liraglutide and placebo. The first subject to meet the treatment criteria will be assigned the first number in the sequence; each subsequent subject to meet treatment criteria will be assigned the next number in the sequence. Unblinding of the treatment codes will occur after all data have been verified and deemed clean by the data managers and statistician, and right before analysis of the data occurs. The code for a particular subject may be broken in a medical emergency if knowing the identity of the treatment allocation would influence the treatment of the subject or if demanded by the subject. Whenever a code is broken, the staff-member breaking the code will record the time, date and reason.

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Binge Episodes

Description

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

Time Frame

baseline and 17 weeks (or last observation carried forward)

Secondary Outcome Measure Information:

Title

Remission From Binge-eating

Description

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

Time Frame

13 to 17 weeks

Title

Assessment of Improvement of Binge Eating Symptoms

Description

Time Frame

week 17 (or last observation carried forward)

Title

Change in Body Weight

Description

changes in body weight

Time Frame

baseline and 17 weeks (or last observation carried forward)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Age ≥ 21 years and ≤ 70 years Meet full DSM 5 criteria for BED 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. 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. All races and ethnicities are included 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 Ability to provide informed consent before any trial-related activities 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: Pregnant or nursing, or plans to become pregnant in the next 6 months, or not using adequate contraceptive measures Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg) Type 1 diabetes Type 2 diabetes 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 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 Clinically significant hepatic or renal disease Thyroid disease, not controlled History of malignancy (except for non-melanoma skin cancer) in past 5 years The presence of current anorexia nervosa or bulimia nervosa 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]. Psychiatric hospitalization within the past 6 months Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week) Diagnosis current or past psychosis 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) Currently receiving behavioral or pharmacological treatment for BED Loss of ≥ 10 lb of body weight within the past 3 months Known or suspected allergy to trial medication(s), excipients, or related products Hypersensitivity to liraglutide or any product components The receipt of any investigational drug within 6 months prior to this trial Previous participation in this trial (e.g., randomized and failed to participate) History of pancreatitis History of gastrointestinal surgery (unless it was an adjustable gastric band that has been removed).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly C Allison, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennyslvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data available to other researchers.

Learn more about this trial

Binge Eating Liraglutide Intervention

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