factorial randomized trial

S-LITE

Synergy Effect of the Appetite Hormone GLP-1 (LiragluTide) and Exercise on Maintenance of Weight Loss and Health After a Low Calorie Diet - the S-LiTE Randomized Trial

Overweight or obesity without diabetes (adults)NCT04122716S000371

Design

Randomized: 195
Start year: 2016
Treatment: 52 weeks, follow-up 52 weeks
Countries: Denmark
Sponsor: Signe Torekov (mixed)
Eligibility: age 18 to 65; BMI 32 to 43; no diabetes; at least 5 percent loss on 8 week low calorie diet

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: randomized
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo and usual activity	usual physical activity; 12 dietary consultations; lifestyle: intensive	49	49
A2	Placebo Exercise and placebo	supervised group exercise twice weekly plus individual exercise twice weekly; 12 dietary consultations; lifestyle: intensive	48	48
A3	Liraglutide 3.0 mg subcutaneous once daily Liraglutide and usual activity	usual physical activity; 12 dietary consultations; lifestyle: intensive	49	49
A4	Liraglutide 3.0 mg subcutaneous once daily Liraglutide and exercise	supervised group exercise twice weekly plus individual exercise twice weekly; 12 dietary consultations; lifestyle: intensive	49	49

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Placebo A2	Liraglutide 3.0 mg subcutaneous once daily A3	Liraglutide 3.0 mg subcutaneous once daily A4	Whole trial ALL
age	mean (years)	42.95	42.97	43.23	42.20
age	sd (years)	11.54	12.37	11.64	12.28
bmi	mean (kg/m2)	32.3	32.7	32.7	32.8
bmi	sd (kg/m2)	3.0	3.0	3.1	2.5
female	n	31	31	31	31
female	percent	65	63	65	65
sbp	mean (mmHg)					122
sbp	sd (mmHg)					13
waist	mean (cm)					100.3
waist	sd (cm)					10.0
weight	mean (kg)	96.7	96.8	95.1	98.3
weight	sd (kg)	12.7	13.2	12.8	11.5

Analyses this trial contributes to

Results

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	change	4.3 mmHg	-0.4 to 9.1	39	not stated; per protocol; R0007438:Table 2
52	A2	change	3.6 mmHg	-2.2 to 9.5	26	not stated; per protocol; R0007438:Table 2
52	A3	change	-0.7 mmHg	-5.7 to 4.3	36	not stated; per protocol; R0007438:Table 2
52	A4	change	1.2 mmHg	-4.3 to 6.8	29	not stated; per protocol; R0007438:Table 2

Percent body weight change (12 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	percent change	6.5 percent		3.8 to 9.2	39	not stated; per protocol; R0006966:Supplementary Table 2
52	A1	percent change	6.4 percent	5.1		24	not stated; per protocol; sex:female; R0003076:Table 1
52	A1	percent change	6.4 percent	7.6		14	not stated; per protocol; sex:male; R0003076:Table 1
52	A2	percent change	-1.8 percent	8.8		15	not stated; per protocol; sex:female; R0003076:Table 1
52	A2	percent change	0.7 percent		-2.6 to 4.0	26	not stated; per protocol; R0006966:Supplementary Table 2
52	A2	percent change	4.1 percent	6.3		11	not stated; per protocol; sex:male; R0003076:Table 1
52	A3	percent change	-4.7 percent	9.6		23	not stated; per protocol; sex:female; R0003076:Table 1
52	A3	percent change	-2.4 percent		-5.2 to 0.4	36	not stated; per protocol; R0006966:Supplementary Table 2
52	A3	percent change	1.5 percent	8.7		13	not stated; per protocol; sex:male; R0003076:Table 1
52	A4	percent change	-6.3 percent		-9.5 to -3.2	29	not stated; per protocol; R0006966:Supplementary Table 2
52	A4	percent change	-0.8 percent	7.8		11	not stated; per protocol; sex:male; R0003076:Table 1
52	A4	percent change	-10.2 percent	10		17	not stated; per protocol; sex:female; R0003076:Table 1

Weight loss of 5 percent or more (1 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
104	A2 vs A3	or	2.9		1.3 to 6.6		treatment policy; other; R0014026:Results

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

Week	Arm	Statistic	Estimate	95% CI	Detail
104	A2 vs A1	or	3.7	1.2 to 11.1	treatment policy; other; R0014026:Results
104	A4 vs A3	or	4.2	1.6 to 10.8	treatment policy; other; R0014026:Results
104	A4 vs A1	or	7.2	2.4 to 21.3	treatment policy; other; R0014026:Results

Physical functioning (any instrument) (14 lines; O24B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	change	-0.9 points	-3.3 to 1.5	39	not stated; per protocol; R0002886:Supplementary Table S2
52	A1	change	-0.6 points	-3.1 to 1.9	48	treatment policy; full analysis; R0002886:Table 2
52	A2	change	2.0 points	-0.5 to 4.6	48	treatment policy; full analysis; R0002886:Table 2
52	A2 vs A1	md	2.6 points	-0.9 to 6.1		treatment policy; full analysis; R0002886:Supplementary Table S3
52	A2	change	3.0 points	0.0 to 5.9	26	not stated; per protocol; R0002886:Supplementary Table S2
52	A3 vs A2	md	-2.0 points	-5.5 to 1.4		treatment policy; full analysis; R0002886:Supplementary Table S3
52	A3	change	0.2 points	-2.3 to 2.7	36	not stated; per protocol; R0002886:Supplementary Table S2
52	A3	change	0.0 points	-2.4 to 2.4	49	treatment policy; full analysis; R0002886:Table 2
52	A3 vs A1	md	0.6 points	-2.8 to 4.0		treatment policy; full analysis; R0002886:Supplementary Table S3
52	A4	change	4.2 points	1.5 to 7.0	29	not stated; per protocol; R0002886:Supplementary Table S2
52	A4	change	3.5 points	1.2 to 5.8	48	treatment policy; full analysis; R0002886:Table 2
52	A4 vs A1	md	4.1 points	0.7 to 7.5		treatment policy; full analysis; R0002886:Supplementary Table S3
52	A4 vs A2	md	1.5 points	-1.9 to 4.9		treatment policy; full analysis; R0002886:Supplementary Table S3
52	A4 vs A3	md	3.5 points	0.2 to 6.8		treatment policy; full analysis; R0002886:Supplementary Table S3

Serious adverse events (4 lines; O25)

Arm	Statistic	Estimate	Detail
A1	events	4	not stated; other; R0007438:Results
A2	events	8	not stated; other; R0007438:Results
A3	events	12	not stated; other; R0007438:Results
A4	events	8	not stated; other; R0007438:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0017714:Results