parallel randomized trial

SCALE™ IBT

Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

Overweight or obesity without diabetes (adults)NCT02963935S000712

Design

Randomized: 282
Start year: 2017
Treatment: 56 weeks, follow-up 60.29 weeks
Countries: United States (17 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 or older; BMI 30 or more; no diabetes; HbA1c below 6.5 percent; stable weight

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: jump to reference multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg plus IBT	CMS based intensive behavioral therapy; lifestyle: intensive	142	142	114
A2	Placebo Placebo plus IBT	CMS based intensive behavioral therapy; lifestyle: intensive	140	140	103

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
age	mean (years)	45.4	49.0
age	sd (years)	11.6	11.2
asian	n	2	3
asian	percent	1.4	2.1
black	n	27	22
black	percent	19.0	15.7
bmi	mean (kg/m2)	39.3	38.7
bmi	sd (kg/m2)	6.8	7.2
female	n	119	116
hba1c	mean (percent)	5.5	5.5
hba1c	sd (percent)	0.4	0.4
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	1	0
sbp	mean (mmHg)	125	127
sbp	sd (mmHg)	15	14
waist	mean (cm)	116	115
waist	sd (cm)	14.4	15.6
weight	mean (kg)	108.5	106.7
weight	sd (kg)	22.1	22.0
white	n	112	115
white	percent	78.9	82.1

Results

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

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	-2.8 mmHg			142	treatment policy; full analysis; R0024012:Table 2
56	A1	change	-2 mmHg	14		142	not stated; full analysis; registry:outcomes
56	A1 vs A2	md	-2.2 mmHg		-4.9 to 0.5		treatment policy; full analysis; R0024012:Table 2
56	A2	change	-0.6 mmHg			140	treatment policy; full analysis; R0024012:Table 2
56	A2	change	-1 mmHg	13		140	not stated; full analysis; registry:outcomes

Percent body weight change (16 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	percent change	-8.4 percent				treatment policy; other; R0024012:Results
28	A2	percent change	-5.4 percent				treatment policy; other; R0024012:Results
56	A1 vs A2	md	-3.4 percent		-5.3 to -1.6		treatment policy; full analysis; R0024012:Results
56	A1	percent change	-9.1 percent			114	while on treatment; other; R0024012:Results
56	A1	percent change	-9.1 percent	7.4		142	while on treatment; full analysis; registry:outcomes
56	A1	percent change	-8.4 percent				hypothetical; full analysis; R0024012:Results
56	A1 vs A2	md	-4.6 percent		-6.5 to -2.6		hypothetical; full analysis; R0024012:Results
56	A1	percent change	-7.5 percent			142	treatment policy; full analysis; R0024012:Results
56	A1	percent change	-7.4 percent	7.9		142	treatment policy; full analysis; registry:outcomes
56	A2	percent change	-4.8 percent	7.6		140	while on treatment; full analysis; registry:outcomes
56	A2	percent change	-3.8 percent				hypothetical; full analysis; R0024012:Results
56	A2 vs A1	md	4.6 percent		2.8 to 6.5		hypothetical; other; R0024841:Abstract
56	A2	percent change	-4.0 percent			140	treatment policy; full analysis; R0024012:Results
56	A2	percent change	-4.0 percent	7.4		140	treatment policy; full analysis; registry:outcomes
56	A2 vs A1	md	3.5 percent		1.6 to 5.3		treatment policy; full analysis; R0024841:Abstract
56	A2	percent change	-4.8 percent			103	while on treatment; other; R0024012:Results

Weight loss of 5 percent or more (8 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
28	A1	responders	69.0			not stated; other; R0024012:Results
28	A2	responders	44.3			not stated; other; R0024012:Results
56	A1 vs A2	or	2.84	1.75 to 4.61		hypothetical; full analysis; registry:outcomes
56	A1	responders	61.5		142	treatment policy; full analysis; R0024012:Results
56	A1 vs A2	or	2.5	1.5 to 4.1		treatment policy; full analysis; R0024012:Results
56	A1	responders	64.08		142	while on treatment; full analysis; registry:outcomes
56	A2	responders	38.57		140	while on treatment; full analysis; registry:outcomes
56	A2	responders	38.8		140	treatment policy; full analysis; R0024012:Results

Weight loss of 10 percent or more (6 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1	responders	33.80		142	while on treatment; full analysis; registry:outcomes
56	A1 vs A2	or	2.14	1.24 to 3.69		hypothetical; full analysis; registry:outcomes
56	A1	responders	30.5		142	treatment policy; full analysis; R0024012:Results
56	A1 vs A2	or	1.8	1.0 to 3.1		treatment policy; full analysis; R0024012:Abstract
56	A2	responders	19.8		140	treatment policy; full analysis; R0024012:Results
56	A2	responders	19.29		140	while on treatment; full analysis; registry:outcomes

Weight loss of 15 percent or more (6 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1 vs A2	or	2.74	1.33 to 5.62		hypothetical; full analysis; registry:outcomes
56	A1	responders	18.1		142	treatment policy; full analysis; R0024012:Results
56	A1 vs A2	or	2.3	1.1 to 4.7		treatment policy; full analysis; R0024012:Abstract
56	A1	responders	20.42		142	while on treatment; full analysis; registry:outcomes
56	A2	responders	8.57		140	while on treatment; full analysis; registry:outcomes
56	A2	responders	8.9		140	treatment policy; full analysis; R0024012:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				0 / 140	while on treatment; safety; R0024012:Table 3

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	3.41 points	6.65		142	not stated; full analysis; registry:outcomes
56	A2	change	3.83 points	7.22		140	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (16 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	14.9 points			142	treatment policy; full analysis; R0024012:Table 2
56	A1	change	15.2 points	21.4		142	while on treatment; full analysis; registry:outcomes
56	A1	change	4.03 points	6.49		142	while on treatment; full analysis; registry:outcomes
56	A1	change	13.5 points	21.4		142	treatment policy; full analysis; registry:outcomes
56	A1 vs A2	md	0.16 points		-1.12 to 1.43		hypothetical; full analysis; registry:outcomes
56	A1	change	3.55 points	6.98		142	treatment policy; full analysis; registry:outcomes
56	A1 vs A2	md	0.9 points		-3.4 to 5.1		treatment policy; full analysis; R0024012:Table 2
56	A1 vs A2	md	0.2 points		-1.2 to 1.5		treatment policy; full analysis; R0024012:Table 2
56	A1 vs A2	md	1.25 points		-2.95 to 5.45		hypothetical; full analysis; registry:outcomes
56	A1	change	4.0 points			142	treatment policy; full analysis; R0024012:Table 2
56	A2	change	15.5 points	23.0		140	treatment policy; full analysis; registry:outcomes
56	A2	change	14.1 points			140	treatment policy; full analysis; R0024012:Table 2
56	A2	change	3.8 points			140	treatment policy; full analysis; R0024012:Table 2
56	A2	change	4.21 points	6.85		140	treatment policy; full analysis; registry:outcomes
56	A2	change	17.5 points	21.4		140	while on treatment; full analysis; registry:outcomes
56	A2	change	4.77 points	6.03		140	while on treatment; full analysis; registry:outcomes

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	13.2 points	18.5		142	treatment policy; full analysis; registry:outcomes
56	A2	change	12.8 points	20.7		140	treatment policy; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				2 / 140	while on treatment; safety; R0024012:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				6 / 140	while on treatment; safety; R0024012:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				68 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				25 / 140	while on treatment; safety; R0024012:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				33 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				7 / 140	while on treatment; safety; R0024012:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				31 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				23 / 140	while on treatment; safety; R0024012:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				43 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				26 / 140	while on treatment; safety; R0024012:Table 3

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 142	while on treatment; safety; cholecystitis acute; registry:adverse_events
	A2	events				0 / 140	while on treatment; safety; cholecystitis acute; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 142	while on treatment; safety; R0024012:Results
	A2	events				0 / 140	while on treatment; safety; R0024012:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 142	while on treatment; safety; R0024012:Results
	A2	events				0 / 140	while on treatment; safety; R0024012:Results

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 142	while on treatment; safety; papillary thyroid cancer; R0024012:Results
A1	events	1 / 142	while on treatment; safety; papillary thyroid cancer; registry:adverse_events
A2	events	0 / 140	while on treatment; safety; papillary thyroid cancer; registry:adverse_events

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 142	while on treatment; safety; R0024012:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 142	while on treatment; safety; R0024012:Table 3
	A2	events				0 / 140	while on treatment; safety; R0024012:Table 3