parallel randomized trial

BARI-STEP

BARI-STEP:A Double-blinded, Randomised, Placebo-controlled Trial of Semaglutide 2.4 mg in Patients With Poor Weight-loss Following Bariatric Surgery.

Overweight or obesity without diabetes (adults)NCT05073835S000434

Design

Randomized: 70
Start year: 2022
Treatment: 68 weeks, follow-up 74 weeks
Countries: United Kingdom (1 sites)
Sponsor: University College London (mixed)
Eligibility: age 18 to 65; at least 1 year after primary bypass or sleeve; less than 20 percent weight loss from surgery

Conduct and analysis

Blinding: double blind
Sequence generation: computer
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	Placebo Placebo	500 kcal deficit diet counseling and exercise advice; lifestyle: standard	35	29
A2	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	500 kcal deficit diet counseling and exercise advice; lifestyle: standard	35	34

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Semaglutide 2.4 mg subcutaneous once weekly A2
age	mean (years)	47.7	46.9
age	sd (years)	10.3	10.4
asian	n	0	2
asian	percent	0.0	5.7
black	n	10	6
black	percent	28.6	17.1
bmi	mean (kg/m2)	40.2	42.8
bmi	sd (kg/m2)	6.0	6.8
female	n	28	30
female	percent	80.0	85.7
hba1c	mean (mmol/mol)	38.9	37.1
hba1c	sd (mmol/mol)	4.2	5.6
other months since surgery	mean (months)	79.1	88.6
other race mixed other	n	4	1
other race mixed other	percent	11.4	2.9
other sleeve gastrectomy	n	28	27
other sleeve gastrectomy	percent	80.0	77.1
other type2 diabetes	n	4	3
other type2 diabetes	percent	11.4	8.6
weight	mean (kg)	111.4	118.6
weight	sd (kg)	19.3	23.3
white	n	21	26
white	percent	60.0	74.3

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
68	A1	change	4.0 mmol/mol	1.5	4	not stated; modified itt; diabetes:t2d; R0014003:Results
68	A2	change	-3.4 mmol/mol	1.8	3	not stated; modified itt; diabetes:t2d; R0014003:Results
68	A2 vs A1	md	-7.4 mmol/mol			not stated; modified itt; diabetes:t2d; R0014003:Results

Systolic blood pressure change (14 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	change	5.01 mmHg	3.10		30	not stated; randomized; R0014003:Supplement Table 3
32	A2	change	-2.17 mmHg	3.14		34	not stated; randomized; R0014003:Supplement Table 3
32	A2 vs A1	md	-7.18 mmHg		-13.94 to -0.43		not stated; randomized; R0014003:Supplement Table 3
52	A1	change	2.75 mmHg	3.14		28	not stated; randomized; R0014003:Supplement Table 3
52	A2	change	-0.13 mmHg	3.16		33	not stated; randomized; R0014003:Supplement Table 3
52	A2 vs A1	md	-2.88 mmHg		-9.77 to 4.02		not stated; randomized; R0014003:Supplement Table 3
68	A1	change	2.0 mmHg	3.1		28	not stated; modified itt; R0014003:Table 2
68	A1	change	2.99 mmHg	3.14		28	not stated; randomized; R0014003:Supplement Table 3
68	A1	change	1.0 mmHg	12.8		28	not stated; modified itt; R0014003:Supplement Table 4
68	A2	change	-3.9 mmHg	3.3		34	not stated; modified itt; R0014003:Table 2
68	A2	change	-1.73 mmHg	3.14		34	not stated; randomized; R0014003:Supplement Table 3
68	A2	change	-5.1 mmHg	10.4		34	not stated; modified itt; R0014003:Supplement Table 4
68	A2 vs A1	md	-5.9 mmHg		-12.0 to 0.2		not stated; modified itt; R0014003:Table 2
68	A2 vs A1	md	-4.72 mmHg		-11.57 to 2.13		not stated; randomized; R0014003:Supplement Table 3

Percent body weight change (18 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	percent change	0.71 percent	1.33		30	not stated; randomized; R0014003:Supplement Table 6
32	A2	percent change	-12.96 percent	1.34		34	not stated; randomized; R0014003:Supplement Table 6
32	A2 vs A1	md	-13.67 percent		-16.42 to -10.92		not stated; randomized; R0014003:Supplement Table 6
52	A1	percent change	1.27 percent	1.34		28	not stated; randomized; R0014003:Supplement Table 6
52	A2	percent change	-16.87 percent	1.35		33	not stated; randomized; R0014003:Supplement Table 6
52	A2 vs A1	md	-18.14 percent		-20.93 to -15.35		not stated; randomized; R0014003:Supplement Table 6
68	A1	percent change	0.9 percent	2.2		29	not stated; modified itt; R0014003:Results
68	A1	percent change	1.10 percent	2.2		25	not stated; per protocol; R0014003:Results
68	A1	percent change	0.96 percent	1.34		29	not stated; randomized; R0014003:Supplement Table 6
68	A1	percent change	0.4 percent	7.0		29	not stated; modified itt; R0014003:Results
68	A2	percent change	-18.2 percent	2.3		34	not stated; modified itt; R0014003:Results
68	A2	percent change	-18.5 percent	2.1		32	not stated; per protocol; R0014003:Results
68	A2	percent change	-18.05 percent	1.34		34	not stated; randomized; R0014003:Supplement Table 6
68	A2	percent change	-18.0 percent	9.2		34	not stated; modified itt; R0014003:Results
68	A2 vs A1	md	-19.1 percent		-23.4 to -14.8		not stated; modified itt; R0014003:Results
68	A2 vs A1	md	-19.3 percent	2.2			not stated; modified itt; R0014003:Supplement sensitivity analyses
68	A2 vs A1	md	-19.6 percent		-23.5 to -15.6		not stated; per protocol; R0014003:Results
68	A2 vs A1	md	-19.00 percent		-21.77 to -16.24		not stated; randomized; R0014003:Supplement Table 6

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
68	A1	responders			2 / 29	not stated; modified itt; R0014003:Results
68	A2	responders			29 / 34	not stated; modified itt; R0014003:Results
68	A2 vs A1	rd	78.4	63.3 to 93.5		not stated; modified itt; R0014003:Supplement Table 2

Weight loss of 15 percent or more (3 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
68	A1	responders			2 / 29	not stated; modified itt; R0014003:Results
68	A2	responders			21 / 34	not stated; modified itt; R0014003:Results
68	A2 vs A1	rd	54.9	36.1 to 73.6		not stated; modified itt; R0014003:Supplement Table 2

Weight loss of 20 percent or more (3 lines; O11D)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
68	A1	responders			1 / 29	not stated; modified itt; R0014003:Results
68	A2	responders			16 / 34	not stated; modified itt; R0014003:Results
68	A2 vs A1	rd	43.6	25.6 to 61.7		not stated; modified itt; R0014003:Supplement Table 2

Physical functioning (any instrument) (5 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	change	7.3 points	4.0		27	not stated; modified itt; R0014003:Table 2
68	A1	change	6.1 points	16.9		27	not stated; modified itt; R0014003:Supplement Table 4
68	A2	change	23.0 points	4.2		34	not stated; modified itt; R0014003:Table 2
68	A2	change	19.9 points	14.7		34	not stated; modified itt; R0014003:Supplement Table 4
68	A2 vs A1	md	15.7 points		7.7 to 23.7		not stated; modified itt; R0014003:Table 2

Health related quality of life total score (any instrument) (14 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	change	7.44 points	3.27		29	not stated; randomized; R0014003:Supplement Table 3
32	A2	change	16.33 points	3.30		33	not stated; randomized; R0014003:Supplement Table 3
32	A2 vs A1	md	8.89 points		2.12 to 15.65		not stated; randomized; R0014003:Supplement Table 3
52	A1	change	6.64 points	3.28		28	not stated; randomized; R0014003:Supplement Table 3
52	A2	change	15.48 points	3.33		31	not stated; randomized; R0014003:Supplement Table 3
52	A2 vs A1	md	8.84 points		2.00 to 15.69		not stated; randomized; R0014003:Supplement Table 3
68	A1	change	9.3 points	3.9		27	not stated; modified itt; R0014003:Table 2
68	A1	change	7.03 points	3.29		27	not stated; randomized; R0014003:Supplement Table 3
68	A1	change	6.7 points	13.4		27	not stated; modified itt; R0014003:Supplement Table 4
68	A2	change	23.7 points	4.1		33	not stated; modified itt; R0014003:Table 2
68	A2	change	21.27 points	3.30		33	not stated; randomized; R0014003:Supplement Table 3
68	A2	change	20.0 points	16.2		33	not stated; modified itt; R0014003:Supplement Table 4
68	A2 vs A1	md	14.3 points		6.5 to 22.1		not stated; modified itt; R0014003:Table 2
68	A2 vs A1	md	14.24 points		7.42 to 21.07		not stated; randomized; R0014003:Supplement Table 3

Serious adverse events (1 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2 vs A1	rr	0.40		0.06 to 1.72		not stated; randomized; R0014003:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; R0014003:Results
	A2	events				1 / 35	not stated; randomized; R0014003:Results

Nausea (3 lines; O27A)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			8 / 35	not stated; randomized; R0014003:Table 3
A2	events			24 / 35	not stated; randomized; R0014003:Table 3
A2 vs A1	rr	3.0	1.7 to 6.3		not stated; randomized; R0014003:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 35	not stated; randomized; R0014003:Table 3
	A2	events				10 / 35	not stated; randomized; R0014003:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 35	not stated; randomized; R0014003:Table 3
	A2	events				21 / 35	not stated; randomized; R0014003:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 35	not stated; randomized; R0014003:Table 3
	A2	events				13 / 35	not stated; randomized; R0014003:Table 3

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; randomized; cholelithiasis; R0014003:Table 3
A1	events	1 / 35	not stated; randomized; gallstones; R0014003:Table 4
A2	events	2 / 35	not stated; randomized; cholelithiasis; R0014003:Table 3
A2	events	0 / 35	not stated; randomized; gallstones; R0014003:Table 4

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; pancreatitis; R0014003:Table 4
	A2	events				0 / 35	not stated; randomized; pancreatitis; R0014003:Table 4