parallel randomized trial

BELIEVE

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

Design

Randomized: 37
Start year: 2017
Treatment: 17 weeks
Countries: United States (1 sites)
Sponsor: University of Pennsylvania (Kelly Allison) (industry)
Eligibility: age 21 to 70; BMI 27 or more; binge eating disorder; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: none		14	7
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: none		13	7

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Liraglutide 3.0 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)	42.8	46.3
age	sd (years)	12.5	7.8
asian	n	0	0
black	n	6	5
black	percent	42.9	38.5
bmi	mean (kg/m2)	35.8	40.1
bmi	sd (kg/m2)	5.7	16.0
female	n	11	6
female	percent	78.6	46.2
other binge episodes per week	mean	2.8	4.9
other binge episodes per week	sd	1.8	3.1
other not hispanic	percent			100
waist	mean (cm)	110.5	111.0
waist	sd (cm)	14.5	11.6
weight	mean (kg)	105.1	107.7
weight	sd (kg)	23.6	19.6
white	n	8	8
white	percent	57.1	61.5

22 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
17	A1	percent change	-0.9 percent	0.9		14	not stated; modified itt; R0014190:Table 3
17	A1 vs A2	md	4.2 percent		1.4 to 7.1		not stated; modified itt; R0014190:Table 3
17	A2	percent change	-5.1 percent	1.0		13	not stated; modified itt; R0014190:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; safety; registry:adverse_events
	A2	events				0 / 19	not stated; safety; registry:adverse_events

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
17	A1	change	5.1 points	2.9		14	not stated; modified itt; R0014190:Table 3
17	A1 vs A2	md	0.6 points		-8.4 to 9.7		not stated; modified itt; R0014190:Table 3
17	A2	change	4.5 points	3.3		13	not stated; modified itt; R0014190:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 17	not stated; safety; registry:adverse_events
	A2	events				2 / 19	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 17	not stated; safety; R0014190:Table 4
	A2	events				5 / 19	not stated; safety; R0014190:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; safety; severe vomiting; R0014190:Table 4
	A2	events				1 / 19	not stated; safety; severe vomiting; R0014190:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; safety; R0014190:Table 4
	A2	events				5 / 19	not stated; safety; R0014190:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; safety; registry:adverse_events
	A2	events				1 / 19	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; safety; cholecystectomy; R0014190:Table 4
	A2	events				1 / 19	not stated; safety; cholecystectomy; R0014190:Table 4

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 17	not stated; safety; suicidal ideation; registry:adverse_events
	A2	events				1 / 19	not stated; safety; suicidal ideation; registry:adverse_events