parallel randomized trial

NCT03038620

Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease

Overweight or obesity without diabetes (adults)NCT03038620S000866

Design

Randomized
Start year: 2017
Treatment: 40 weeks, follow-up 40 weeks
Countries: United States (1 sites)
Sponsor: University of Texas Southwestern Medical Center (industry)
Eligibility: age 35 or more; BMI 30 or more, or 27 or more with metabolic syndrome; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: standard	92	73
A2	Placebo Placebo	lifestyle: standard	93	55

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)	49.6	50.9
age	median (years)	49	51
age	q1 (years)	42	45
age	q3 (years)	56	56
age	sd (years)	9.8	8.8
asian	n	0	0
black	n	28	19
black	percent	38.4	34.5
bmi	mean (kg/m2)	37.2	38.1
bmi	median (kg/m2)	37.2	36.4
bmi	q1 (kg/m2)	32.3	33.8
bmi	q3 (kg/m2)	40.3	42.5
bmi	sd (kg/m2)	6.0	6.1
female	n	67	51
female	percent	91.8	92.7
hispanic	n	18	12
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	0	0
sbp	mean (mmHg)	130.3	125.8
sbp	median (mmHg)	131	126
sbp	q1 (mmHg)	120	116
sbp	q3 (mmHg)	139	135
sbp	sd (mmHg)	14.9	13.9
waist	mean (cm)	105.5	104.8
waist	sd (cm)	12.2	10.6
weight	mean (kg)	101.0	102.3
weight	median (kg)	100.5	101.9
weight	q1 (kg)	88.1	89.9
weight	q3 (kg)	114.9	117.2
weight	sd (kg)	17.9	17.9
white	n	43	35
white	percent	58.9	63.6

Analyses this trial contributes to

Results

8 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
40	A1	change	-5.84 mmHg	17.98		73	not stated; completers; registry:outcomes
40	A2	change	-0.02 mmHg	16.01		55	not stated; completers; registry:outcomes

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
40	A1	percent change	-6.59 percent	4.80		73	not stated; completers; registry:outcomes
40	A2	percent change	-1.19 percent	4.68		55	not stated; completers; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 92	not stated; randomized; registry:adverse_events
	A2	events				0 / 93	not stated; randomized; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 92	not stated; randomized; registry:adverse_events
	A2	events				0 / 93	not stated; randomized; registry:adverse_events