Binge Eating Liraglutide Intervention
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml; 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). 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.; 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
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel 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.
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: eating disorder, pharmacotherapy

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.
    

Eligibility 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).