parallel randomized trial

NCT02918279

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

Children and adolescents with obesity NCT02918279S000599

Design

Randomized: 251
Start year: 2016
Treatment: 56 weeks, follow-up 82 weeks
Countries: Belgium, Mexico, Russia, Sweden, United States (32 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: pubertal age 12 to under 18; BMI equivalent to adult 30 or more; poor response to lifestyle therapy

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle therapy throughout; lifestyle: standard	125	125	101
A2	Placebo Placebo	lifestyle therapy throughout; lifestyle: standard	126	126	100

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2	Whole trial ALL
age: 12 to 14	n	54	64
age: 12 to 14	percent	43.2	50.8
age: 15 to 17	n	71	62
age: 15 to 17	percent	56.8	49.2
age	mean (years)	14.6	14.5
age	sd (years)	1.6	1.6
asian	n	2	0
black	n	14	6
bmi sds	mean			3.17
bmi	mean (kg/m2)	35.3	35.8
bmi	sd (kg/m2)	5.1	5.7
female	n	71	78
female	percent		61.9
hispanic	n	32	24
hispanic	percent	25.6	19.0
other race american indian alaska native	n	0	1
other race native hawaiian pacific islander	n	0	0
other race other	n	4	4
weight	mean (kg)	99.3	102.2
weight	sd (kg)	19.7	21.6
white	n	105	115
white	percent	84.0	91.3

Analyses this trial contributes to

Results

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

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
30	A1	percent change	-4.3 percent	6.5	125	not stated; full analysis; registry:outcomes
30	A2	percent change	0.4 percent	6.2	126	not stated; full analysis; registry:outcomes
56	A1	percent change	-3.2 percent	9.4	125	not stated; full analysis; registry:outcomes
56	A2	percent change	2.2 percent	9.5	126	not stated; full analysis; registry:outcomes

BMI standard deviation score change (7 lines; O13A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-0.26 SDS	0.34		125	treatment policy; full analysis; registry:outcomes
30	A2	change	-0.04 SDS	0.33		126	treatment policy; full analysis; registry:outcomes
56	A1	change	-0.25 SDS	0.51		113	treatment policy; full analysis; registry:outcomes
56	A1 vs A2	md	-0.22 SDS		-0.37 to -0.08		treatment policy; full analysis; registry:outcomes
56	A2	change	-0.02 SDS	0.54		105	treatment policy; full analysis; registry:outcomes
82	A1	change	-0.06 SDS	0.53		125	treatment policy; full analysis; registry:outcomes
82	A2	change	0.07 SDS	0.66		126	treatment policy; full analysis; registry:outcomes

Percent BMI change (1 lines; O13B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1 vs A2	md	-4.64 percent		-7.14 to -2.14		not stated; other; R0024039:Abstract

Physical functioning (any instrument) (4 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
30	A1	change	3.94 points	15.34	125	not stated; completers; registry:outcomes
30	A2	change	0.43 points	22.02	126	not stated; completers; registry:outcomes
56	A1	change	6.17 points	15.44	125	not stated; completers; registry:outcomes
56	A2	change	3.32 points	16.60	126	not stated; completers; registry:outcomes

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
30	A1	change	6.16 points	11.04	125	not stated; completers; registry:outcomes
30	A2	change	2.24 points	19.69	126	not stated; completers; registry:outcomes
56	A1	change	7.46 points	13.70	125	not stated; completers; registry:outcomes
56	A2	change	6.72 points	11.62	126	not stated; completers; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 125	while on treatment; safety; registry:adverse_events
	A2	events				5 / 126	while on treatment; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				53 / 125	while on treatment; safety; registry:adverse_events
	A2	events				18 / 126	while on treatment; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				43 / 125	while on treatment; safety; registry:adverse_events
	A2	events				5 / 126	while on treatment; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				28 / 125	while on treatment; safety; registry:adverse_events
	A2	events				18 / 126	while on treatment; safety; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 125	while on treatment; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 125	while on treatment; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 126	while on treatment; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 126	while on treatment; safety; cholelithiasis; registry:adverse_events

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 125	while on treatment; safety; completed suicide; registry:adverse_events
	A2	events				0 / 126	while on treatment; safety; completed suicide; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 125	while on treatment; safety; registry:adverse_events
	A2	events				0 / 126	while on treatment; safety; registry:adverse_events