parallel randomized trial

STEP7

Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.

Overweight or obesity without diabetes (adults)NCT04251156S001288

Design

Randomized: 375
Start year: 2020
Treatment: 44 weeks, follow-up 51 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or older; BMI 30 or more, or 27 or more with a weight related comorbidity including T2D

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: multiple imputation from retrieved participants

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	lifestyle: standard	249	249
A2	Placebo Placebo	lifestyle: standard	126	126

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 2.4 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	41	40
age	sd (years)	11	11
asian	n	225	115
black	n	2	2
female	n	111	59
hispanic	n	26	11
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	0	0
white	n	22	9

Analyses this trial contributes to

Results

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

HbA1c change (1 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1 vs A2	md	-1.5 percent		-1.9 to -1.1		treatment policy; full analysis; region:china_t2d; R0017470:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	responders				57 / 62	not stated; full analysis; diabetes:t2d; registry:outcomes
44	A2	responders				8 / 28	not stated; full analysis; diabetes:t2d; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	change	-7 mmHg	12		238	not stated; full analysis; registry:outcomes
44	A2	change	-2 mmHg	12		116	not stated; full analysis; registry:outcomes

Percent body weight change (19 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1 vs A2	md	-9.3 percent		-11.8 to -6.8		hypothetical; other; region:china_age_less_than_40; R0017470:Supplement Table S3
44	A1 vs A2	md	-8.5 percent		-11.4 to -5.6		hypothetical; other; region:china_bmi_30_to_less_than_35; R0017470:Supplement Table S3
44	A1 vs A2	md	-8.1 percent		-11.2 to -5.0		hypothetical; other; region:china_bmi_35_or_more; R0017470:Supplement Table S3
44	A1 vs A2	md	-8.1 percent		-12.3 to -3.9		hypothetical; other; region:china_bmi_less_than_30; R0017470:Supplement Table S3
44	A1 vs A2	md	-9.7 percent		-13.0 to -6.3		hypothetical; other; region:china_female; R0017470:Supplement Table S3
44	A1	percent change	-12.5 percent	7.4		238	not stated; full analysis; registry:outcomes
44	A1 vs A2	md	-8.47 percent		-10.17 to -6.76		not stated; full analysis; registry:outcomes
44	A1 vs A2	md	-7.1 percent		-11.1 to -3.2		hypothetical; other; region:china_age_40_to_less_than_50; R0017470:Supplement Table S3
44	A1 vs A2	md	-6.7 percent		-10.8 to -2.7		hypothetical; other; region:china_age_50_or_more; R0017470:Supplement Table S3
44	A1 vs A2	md	-7.4 percent		-9.8 to -5.0		hypothetical; other; region:china_male; R0017470:Supplement Table S3
44	A1 vs A2	md	-9.2 percent		-11.5 to -6.9		hypothetical; other; region:china_no_t2d; R0017470:Supplement Table S3
44	A1 vs A2	md	-5.7 percent		-9.0 to -2.3		hypothetical; other; region:china_t2d; R0017470:Supplement Table S3
44	A1	percent change	-12.5 percent			195	hypothetical; full analysis; region:china; R0017470:Supplement Table S3
44	A1 vs A2	md	-9.7 percent		-11.3 to -8.1		hypothetical; full analysis; region:china; R0017470:Supplement Table S3
44	A1	percent change	-11.8 percent			195	treatment policy; full analysis; region:china; R0017470:Table 2
44	A1 vs A2	md	-8.3 percent		-10.2 to -6.4		treatment policy; full analysis; region:china; R0017470:Table 2
44	A2	percent change	-3.5 percent			105	treatment policy; full analysis; region:china; R0017470:Table 2
44	A2	percent change	-3.6 percent	5.9		116	not stated; full analysis; registry:outcomes
44	A2	percent change	-2.8 percent			105	hypothetical; full analysis; region:china; R0017470:Supplement Table S3

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
44	A1	responders			203 / 238	not stated; full analysis; registry:outcomes
44	A1 vs A2	or	13.07	7.40 to 23.10		not stated; full analysis; registry:outcomes
44	A2	responders			36 / 116	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	responders				151 / 238	not stated; full analysis; registry:outcomes
44	A2	responders				12 / 116	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	responders				82 / 238	not stated; full analysis; registry:outcomes
44	A2	responders				7 / 116	not stated; full analysis; registry:outcomes

Weight loss of 20 percent or more (2 lines; O11D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	responders				34 / 238	not stated; full analysis; registry:outcomes
44	A2	responders				2 / 116	not stated; full analysis; registry:outcomes

Progression to type 2 diabetes (2 lines; O14)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 173	not stated; full analysis; diabetes:none; registry:outcomes
	A2	events				2 / 84	not stated; full analysis; diabetes:none; registry:outcomes

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 249	not stated; safety; registry:adverse_events
A1	events	0 / 195	treatment policy; safety; region:china; R0017470:Table 3
A2	events	0 / 126	not stated; safety; registry:adverse_events
A2	events	0 / 105	treatment policy; safety; region:china; R0017470:Table 3

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	change	1.4 points	5.2		237	not stated; full analysis; registry:outcomes
44	A2	change	0.4 points	5.5		116	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (4 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
44	A1	change	8.0 points	16.4	236	not stated; full analysis; registry:outcomes
44	A1	change	1.3 points	4.7	237	not stated; full analysis; registry:outcomes
44	A2	change	0.2 points	5.7	116	not stated; full analysis; registry:outcomes
44	A2	change	2.3 points	18.5	115	not stated; full analysis; registry:outcomes

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
44	A1	change	10.3 points	15.4		236	not stated; full analysis; registry:outcomes
44	A2	change	3.8 points	16.2		115	not stated; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 249	not stated; safety; registry:adverse_events
	A2	events				8 / 126	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				60 / 249	not stated; safety; registry:adverse_events
	A2	events				9 / 126	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				21 / 249	not stated; safety; registry:adverse_events
	A2	events				0 / 126	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				65 / 249	not stated; safety; registry:adverse_events
	A2	events				13 / 126	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 249	not stated; safety; registry:adverse_events
	A2	events				7 / 126	not stated; safety; registry:adverse_events

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 249	not stated; safety; Papillary thyroid cancer; registry:adverse_events
	A2	events				0 / 126	not stated; safety; Papillary thyroid cancer; registry:adverse_events