Binge Episodes
| Group | Value (objective binge episodes per week) | Spread |
|---|---|---|
| Liraglutide | -3.97 | 0.56 |
| Placebo | -2.50 | .053 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataShort name BELIEVE
This trial was stopped early.
Reason given at the registry: The study was not meeting recruitment goals.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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.
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.
Outcomes the sponsor listed as primary.
Binge Episodes
Time frame · baseline and 17 weeks (or last observation carried forward)
Change in objective binge episodes per week from randomization (week 0) to study end (week 17)
Remission From Binge-eating
Time frame · 13 to 17 weeks
the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)
Assessment of Improvement of Binge Eating Symptoms
Time frame · week 17 (or last observation carried forward)
week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project \[prior to medication initiation\], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.
Change in Body Weight
Time frame · baseline and 17 weeks (or last observation carried forward)
changes in body weight
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (objective binge episodes per week) | Spread |
|---|---|---|
| Liraglutide | -3.97 | 0.56 |
| Placebo | -2.50 | .053 |
| Group | Value (Participants) |
|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 3 |
| Placebo | 4 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 1.52 | .27 |
| Placebo | 1.93 | .26 |
| Group | Value (kg) | Spread |
|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | -4.7 | 0.83 |
| Placebo | -0.94 | 0.73 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3MlPre-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. 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. | 0 / 19 | 2 / 19 | 17 / 19 |
| PlaceboPre-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. Placebo: 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 | 0 / 17 | 1 / 17 | 11 / 17 |
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