parallel randomized trial

NCT02717858

A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects

Overweight or obesity without diabetes (adults)NCT02717858S000103

Design

Randomized: 52
Start year: 2016
Treatment: 12 weeks, follow-up 16.1 weeks
Countries: Denmark (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 64, BMI 27 or more, no diabetes, no gallbladder disease

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	none; lifestyle: intensive	26	23
A2	Placebo Placebo	none; lifestyle: intensive	26	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)	47.6	47.5
age	sd (years)	10.4	9.7
bmi	mean (kg/m2)	32.5	32.6
bmi	sd (kg/m2)	3.6	3.3
female	n	13	13
female	percent	50.0	50.0
weight	mean (kg)	98.2	99.8
weight	sd (kg)	17.0	14.7

Analyses this trial contributes to

Results

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

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	percent change	-8.2 percent	1.8		23	not stated; completers; R0024932:Results
12	A2	percent change	-5.5 percent	3.6		24	not stated; completers; R0024932:Results

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders	100			23	not stated; completers; R0024932:Results
12	A2	responders				13 / 24	not stated; completers; R0024932:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; R0024932:Results
	A2	events				1 / 26	not stated; safety; R0024932:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; R0024932:Results
	A2	events				1 / 26	not stated; safety; R0024932:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 26	not stated; safety; cholelithiasis; R0024932:Results
	A2	events				0 / 26	not stated; safety; cholelithiasis; R0024932:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; R0024932:Results
	A2	events				0 / 26	not stated; safety; R0024932:Results

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; R0024932:Results
	A2	events				0 / 26	not stated; safety; R0024932:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 26	not stated; safety; R0024932:Results
	A2	events				0 / 26	not stated; safety; R0024932:Results