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Trial record 17 of 128 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

Binge Eating Liraglutide Intervention (BELIEVE)

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ClinicalTrials.gov Identifier: NCT03279731
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kelly Allison, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-center, double-blind, randomized placebo-controlled trial with parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment
Official Title: Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
Drug Information available for: Liraglutide

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




Primary Outcome Measures :
  1. Binge Episodes [ Time Frame: 17 weeks ]
    change in binge episodes per week from randomization (week 0) to study end (week 17)


Secondary Outcome Measures :
  1. Remission from binge-eating [ Time Frame: 17 weeks ]
    the proportion of participants who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)

  2. Assessment of improvement of binge eating symptoms [ Time Frame: 17 weeks ]
    week 17 rating on the interviewer-based Clinical Global Impression of Improvement Scale for global assessment of BED symptoms

  3. Change in Body Weight [ Time Frame: 17 weeks ]
    changes in body weight measured in kilograms

  4. Self-Report cognitive restraint from the Eating Inventory Questionnaire [ Time Frame: 17 weeks ]
    self-report measure of cognitive restraint will be measured from the Eating Inventory questionnaire.

  5. Self-Report dietary disinhibition of from the Eating Inventory Questionnaire [ Time Frame: 17 weeks ]
    self-report measure of dietary disinhibition will be measured from the Eating Inventory questionnaire.

  6. Self-Report perceived hunger from the Eating Inventory Questionnaire [ Time Frame: 17 weeks ]
    self-report measure of perceived hunger will be measured from the Eating Inventory questionnaire.

  7. Self-Report Measure of Quality of Life [ Time Frame: 17 weeks ]
    Self report measure of quality of life will be measured using the Quality of Life, Enjoyment and Satisfaction Questionnaire

  8. Self-Report Measures of Mood [ Time Frame: 17 weeks ]
    Score from the Patient Health Questionnaire 9-Item version (PHQ-9) will be used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279731


Contacts
Contact: Elizabeth Jones, BS 215-573-5502 ejonesa@pennmedicine.upenn.edu
Contact: Kelly C Allison, PhD 215-898-2823 kca@pennmedicine.upenn.edu

Locations
United States, Pennsylvania
University of Pennyslvania Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Kelly C Allison, PhD    215-898-2823    kca@pennmedicine.upenn.edu   
Contact: Madelyn Ruggieri, MS    215-573-5502    mrugg@pennmedicine.upenn.edu   
Principal Investigator: Kelly C Allison, PhD         
Sub-Investigator: Thomas A Wadden, PhD         
Sub-Investigator: Robert Berkowitz, MD         
Sponsors and Collaborators
Kelly Allison
Novo Nordisk A/S
Investigators
Principal Investigator: Kelly C Allison, PhD University of Pennsylvania

Responsible Party: Kelly Allison, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03279731     History of Changes
Other Study ID Numbers: 827450
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Allison, University of Pennsylvania:
eating disorder, pharmacotherapy

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists