parallel randomized trial

NCT03523273

Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

Design

Randomized: 136
Start year: 2017
Treatment: 16 weeks, follow-up 18 weeks
Countries: United States (1 sites)
Sponsor: Mayo Clinic (Michael Camilleri) (non industry)
Eligibility: age 18 to 65; BMI 30 or more; no diabetes; no delayed gastric emptying

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: standard	69
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: standard	67

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
age	median (years)	37.2	42
age	q1 (years)	29.3	32
age	q3 (years)	45.2	51
asian	n	0	0
black	n	0	0
bmi substudy:liver_ultrasound	mean (kg/m2)	38.4	37.0
bmi substudy:liver_ultrasound	sd (kg/m2)	5.7	4.3
female	n	59	59
other race unknown	n	4	7
white	n	65	60

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

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 69	not stated; randomized; registry:adverse_events
	A2	events				0 / 67	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				1 / 69	not stated; randomized; registry:adverse_events
	A2	events				1 / 67	not stated; randomized; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 69	not stated; randomized; registry:adverse_events
	A2	events				40 / 67	not stated; randomized; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 69	not stated; randomized; registry:adverse_events
	A2	events				23 / 67	not stated; randomized; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 69	not stated; randomized; registry:adverse_events
	A2	events				18 / 67	not stated; randomized; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 69	not stated; randomized; Cholecystectomy for acute cholecystitis associated with gallstones; registry:adverse_events
	A2	events				1 / 67	not stated; randomized; Cholecystectomy for acute cholecystitis associated with gallstones; registry:adverse_events