Binge Eating Liraglutide Intervention (BELIEVE)
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|ClinicalTrials.gov Identifier: NCT03279731|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Binge-Eating Disorder||Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml Drug: Placebo||Phase 3|
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|
|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)|
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.
|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|
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.
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
- Binge Episodes [ Time Frame: 17 weeks ]change in binge episodes per week from randomization (week 0) to study end (week 17)
- 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)
- 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
- Change in Body Weight [ Time Frame: 17 weeks ]changes in body weight measured in kilograms
- 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.
- 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.
- 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.
- 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
- Self-Report Measures of Mood [ Time Frame: 17 weeks ]Score from the Patient Health Questionnaire 9-Item version (PHQ-9) will be used
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
|Contact: Madelyn R Ruggieri, MSfirstname.lastname@example.org|
|Contact: Kelly C Allison, PhDemail@example.com|
|United States, Pennsylvania|
|University of Pennyslvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Kelly C Allison, PhD 215-898-2823 firstname.lastname@example.org|
|Contact: Madelyn Ruggieri, MS 215-573-5502 email@example.com|
|Principal Investigator: Kelly C Allison, PhD|
|Sub-Investigator: Thomas A Wadden, PhD|
|Sub-Investigator: Robert Berkowitz, MD|