parallel randomized trial

BARIOPTIMISE

BARI-OPTIMISE: a Double-blinded, Randomised, Placebo-controlled Trial of Liraglutide 3.0 mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response Following Bariatric Surgery

Overweight or obesity without diabetes (adults)NCT03341429S000466

Design

Randomized: 70
Start year: 2018
Treatment: 24 weeks, follow-up 28 weeks
Countries: United Kingdom (1 sites)
Sponsor: University College London (mixed)
Eligibility: adults at least 1 year after RYGB or sleeve gastrectomy with 20 percent or less weight loss and suboptimal GLP-1 response

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: standard	35	26
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: standard	35	31

Baseline characteristics

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	mean (years)	48.4	46.7
age	sd (years)	10.6	10.8
asian	n	1	4
black	n	9	5
bmi	mean (kg/m2)	44.6	41.6
bmi	sd (kg/m2)	8.3	6.9
female	n	26	26
female	percent	74	74
hba1c	mean (percent)	6.0	5.8
hba1c	sd (percent)	0.9	0.7
other months since surgery	mean (months)	49.1	55.1
other sleeve gastrectomy	n	32	33
other type2 diabetes	n	4	5
other type2 diabetes	percent	11	14
sbp	mean (mmHg)	131.3	131.3
sbp	sd (mmHg)	14.5	15.0
weight	mean (kg)	123.5	116.1
weight	sd (kg)	24.8	23.6
white	n	22	22

Analyses this trial contributes to

Results

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

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	2.34 mmHg	18.93		32	not stated; modified itt; R0017334:Table 2
24	A2	change	-6.28 mmHg	16.40		32	not stated; modified itt; R0017334:Table 2
24	A2 vs A1	md	-9.05 mmHg		-16.24 to -1.85		not stated; modified itt; R0017334:Table 2

Percent body weight change (12 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	percent change	-0.54 percent	3.32		26	not stated; modified itt; R0017334:Results
24	A1	percent change	-0.14 percent	3.28		34	not stated; modified itt; R0017334:eTable 1
24	A1	percent change	-0.86 percent	3.23		23	not stated; per protocol; R0017334:Results
24	A1	percent change	-0.14 percent	3.28		34	not stated; modified itt; R0017334:Results
24	A2	percent change	-8.82 percent	4.94		31	not stated; modified itt; R0017334:Results
24	A2	percent change	-8.6 percent	4.96		32	not stated; modified itt; R0017334:eTable 1
24	A2	percent change	-9.05 percent	4.85		30	not stated; per protocol; R0017334:Results
24	A2	percent change	-8.65 percent	4.96		32	not stated; modified itt; R0017334:Results
24	A2 vs A1	md	-8.03 percent		-10.39 to -5.66		not stated; modified itt; R0017334:Results
24	A2 vs A1	md	-8.44 percent		-9.71 to -7.18		not stated; modified itt; R0017334:eTable 1
24	A2 vs A1	md	-7.67 percent		-10.14 to -5.21		not stated; per protocol; R0017334:Results
24	A2 vs A1	md	-8.29 percent		-10.42 to -6.16		not stated; modified itt; R0017334:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	8.8			3 /	not stated; other; R0017334:Supplement eTable 2
24	A2	responders	71.9			23 /	not stated; other; R0017334:Supplement eTable 2

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	0			0 /	not stated; other; R0017334:Supplement eTable 2
24	A2	responders	28.1			9 /	not stated; other; R0017334:Supplement eTable 2

Weight loss of 15 percent or more (2 lines; O11C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	0			0 /	not stated; other; R0017334:Supplement eTable 2
24	A2	responders	12.5			4 /	not stated; other; R0017334:Supplement eTable 2

Physical functioning (any instrument) (3 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.28 points	11.29		33	not stated; modified itt; R0017334:Table 2
24	A2	change	5.54 points	18.48		32	not stated; modified itt; R0017334:Table 2
24	A2 vs A1	md	7.54 points		0.10 to 14.99		not stated; modified itt; R0017334:Table 2

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.93 points	10.70		33	not stated; modified itt; R0017334:Table 2
24	A2	change	4.98 points	15.05		32	not stated; modified itt; R0017334:Table 2
24	A2 vs A1	md	7.13 points		0.60 to 13.66		not stated; modified itt; R0017334:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 35	not stated; randomized; R0017334:Table 3
	A2	events				0 / 35	not stated; randomized; R0017334:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 35	not stated; randomized; R0017334:Table 3
	A2	events				18 / 35	not stated; randomized; R0017334:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; R0017334:Table 3
	A2	events				1 / 35	not stated; randomized; R0017334:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 35	not stated; randomized; R0017334:Table 3
	A2	events				2 / 35	not stated; randomized; R0017334:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 35	not stated; randomized; R0017334:Table 3
	A2	events				9 / 35	not stated; randomized; R0017334:Table 3

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 35	not stated; randomized; acute cholecystitis; R0017334:Results
	A2	events				0 / 35	not stated; randomized; acute cholecystitis; R0017334:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 35	not stated; randomized; R0017334:Results
	A2	events				0 / 35	not stated; randomized; R0017334:Results