Binge Eating Liraglutide Intervention

• Status: Terminated
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kelly Allison
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

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).