Status:
TERMINATED
Binge Eating Liraglutide Intervention
Lead Sponsor:
Kelly Allison
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Binge-Eating Disorder
Eligibility:
All Genders
21-70 years
Phase:
PHASE3
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 numb...
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 inter...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03279731
Start Date
September 29 2017
End Date
October 1 2019
Last Update
November 24 2020
Active Locations (1)
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1
University of Pennyslvania
Philadelphia, Pennsylvania, United States, 19140