parallel randomized trial

S003017

Overweight or obesity without diabetes (adults)S003017

Design

Randomized: 48
Start year: 2019
Treatment: 52.14 weeks, follow-up 52.14 weeks
Countries: Australia (1 sites)
Sponsor: (industry)
Eligibility: age 20 to 65; BMI above 35; 12 to 36 months after bariatric surgery with suboptimal stable weight loss or regain

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: mixed model, observed data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	prior bariatric surgery; common eating behavior program; lifestyle: standard	24	24
A2	Placebo Placebo	prior bariatric surgery; common eating behavior program; lifestyle: standard	24	24

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)	48.7	43.6
age	sd (years)	10.5	11.4
bmi	mean (kg/m2)	39.2	36.9
bmi	sd (kg/m2)	5.2	4.3
female	n	22	20
female	percent	92	83
hba1c	mean (percent)	5.3	5.3
hba1c	sd (percent)	0.3	0.3
sbp	mean (mmHg)	125	133
sbp	sd (mmHg)	12	14
weight	mean (kg)	104.4	101.9
weight	se (kg)	3.3	3.3

Analyses this trial contributes to

Results

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

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	final	124 mmHg	12		15	not stated; other; R0016758:Table 1
52.14	A2	final	133 mmHg	12		8	not stated; other; R0016758:Table 1

Percent body weight change (24 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Detail
21.73	A1	percent change	-3.53 percent	0.78		not stated; randomized; R0016758:Supplement eTable 1
21.73	A1 vs A2	md	-3.95 percent		-6.22 to -1.67	not stated; randomized; R0016758:Supplement eTable 1
21.73	A2	percent change	0.41 percent	0.86		not stated; randomized; R0016758:Supplement eTable 1
26.07	A1	percent change	-3.49 percent	0.79		not stated; randomized; R0016758:Supplement eTable 1
26.07	A1 vs A2	md	-3.32 percent		-5.63 to -1.02	not stated; randomized; R0016758:Supplement eTable 1
26.07	A2	percent change	-0.16 percent	0.88		not stated; randomized; R0016758:Supplement eTable 1
30.42	A1	percent change	-4.19 percent	0.79		not stated; randomized; R0016758:Supplement eTable 1
30.42	A1 vs A2	md	-3.87 percent		-6.20 to -1.53	not stated; randomized; R0016758:Supplement eTable 1
30.42	A2	percent change	-0.33 percent	0.89		not stated; randomized; R0016758:Supplement eTable 1
34.76	A1	percent change	-3.82 percent	0.81		not stated; randomized; R0016758:Supplement eTable 1
34.76	A1 vs A2	md	-3.45 percent		-5.90 to -0.99	not stated; randomized; R0016758:Supplement eTable 1
34.76	A2	percent change	-0.38 percent	0.96		not stated; randomized; R0016758:Supplement eTable 1
39.11	A1	percent change	-3.52 percent	0.81		not stated; randomized; R0016758:Supplement eTable 1
39.11	A1 vs A2	md	-3.48 percent		-5.93 to -1.02	not stated; randomized; R0016758:Supplement eTable 1
39.11	A2	percent change	-0.04 percent	0.96		not stated; randomized; R0016758:Supplement eTable 1
43.45	A1	percent change	-4.41 percent	0.85		not stated; randomized; R0016758:Supplement eTable 1
43.45	A1 vs A2	md	-4.52 percent		-7.02 to -2.01	not stated; randomized; R0016758:Supplement eTable 1
43.45	A2	percent change	0.11 percent	0.96		not stated; randomized; R0016758:Supplement eTable 1
47.8	A1	percent change	-4.13 percent	0.86		not stated; randomized; R0016758:Supplement 2 eTable 1
47.8	A1 vs A2	md	-4.12 percent		-6.65 to -1.60	not stated; randomized; R0016758:Supplement 2 eTable 1
47.8	A2	percent change	-0.01 percent	0.96		not stated; randomized; R0016758:Supplement 2 eTable 1
52.14	A1	percent change	-4.4 percent	0.9		not stated; randomized; R0016758:Results
52.14	A1 vs A2	md	-5.81 percent		-8.33 to -3.29	not stated; randomized; R0016758:Supplement 2 eTable 1
52.14	A2	percent change	1.4 percent	1.0		not stated; randomized; R0016758:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; safety; R0016758:Discussion
	A2	events				0 / 24	not stated; safety; R0016758:Discussion

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; safety; R0016758:Discussion
	A2	events				0 / 24	not stated; safety; R0016758:Discussion

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52.14	A1	change	-10.0 points	4.3	19	not stated; other; R0016758:Supplement eTable 7
52.14	A1	final	76.1 points	4.5	19	not stated; other; R0016758:Results
52.14	A2	change	-0.9 points	5.9	10	not stated; other; R0016758:Supplement eTable 7
52.14	A2	final	92.5 points	6.2	10	not stated; other; R0016758:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; safety; R0016758:Discussion
	A2	events				0 / 24	not stated; safety; R0016758:Discussion

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; safety; R0016758:Discussion
	A2	events				0 / 24	not stated; safety; R0016758:Discussion