Phase 3 · Liraglutide

BELIEVE trial results

Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder

Binge Episodes (objective binge episodes per week), baseline and 17 weeks (or last observation carried forward). Liraglutide: -3.97; Placebo: -2.50.

Participants
36
Status
terminated
Completed
2019-10-01
Sponsor
Kelly Allison

As posted on ClinicalTrials.gov (NCT03279731), updated at source Nov 24, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What BELIEVE measured first

Binge Episodesobjective binge episodes per week · baseline and 17 weeks (or last observation carried forward) · mean
Liraglutiden=13Placebon=14
-3.97(0.56)-2.50(.053)
Side effects by arm

Side effects in BELIEVE

Percent of participants affected, from the beginning to the end of the 17 week trial. The most common events the registry lists.

EventLiraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlPlacebo
Any serious event10.5%5.9%
nausea26.3%17.6%
diarrhea26.3%0%
dry mouth15.8%0%
tachycardua15.8%0%
indigestion10.5%11.8%
joint pain5.3%11.8%
upper respiratory infection10.5%5.9%
gastroenteritis10.5%5.9%
suicidal ideation5.3%5.9%
fatigue0%5.9%
depressive symptoms0%5.9%
UTI0%5.9%
strep throat0%5.9%
sty0%5.9%
cholitis flare0%5.9%
insomnia0%5.9%
allergic rhinitis0%5.9%
common cold0%5.9%
toothache0%5.9%
worsening edema0%5.9%
constipation5.3%0%
bilateral otitis media5.3%0%
flu5.3%0%
headache5.3%0%
vaginal bleeding5.3%0%
Secondary outcomes

What else it measured

Remission From Binge-eatingParticipants · 13 to 17 weeks · count of participants
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Mln=7Placebon=8
34
Assessment of Improvement of Binge Eating Symptomsunits on a scale · week 17 (or last observation carried forward) · mean
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Mln=13Placebon=14
1.52(.27)1.93(.26)
Change in Body Weightkg · baseline and 17 weeks (or last observation carried forward) · mean
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Mln=13Placebon=14
-4.7(0.83)-0.94(0.73)
The trial

How BELIEVE was run

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.

  • 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.
  • 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.
Who could join the trial

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...

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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