parallel randomized trial

STEP 4

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

Design

Randomized: 803
Start year: 2018
Treatment: 48 weeks, follow-up 55 weeks
Countries: multinational
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or more; BMI 30 or more, or 27 or more with comorbidity; no diabetes; reached 2.4 mg at week 20

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Continued semaglutide 2.4 mg	lifestyle: standard	535	535	504
A2	Placebo Switched to placebo	lifestyle: standard	268	268	237

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: 20 to less than 40	n	147	72
age: 20 to less than 40	percent	27.5	26.9
age: 40 to less than 60	n	313	164
age: 40 to less than 60	percent	58.5	61.2
age: 60 to less than 80	n	74	32
age: 60 to less than 80	percent	13.8	11.9
age: 80 or more	n	0	0
age: less than 20	n	1	0
age: less than 20	percent	0.2
age	mean (years)	47	46
age	sd (years)	12	12
asian	n	15	4
asian	percent	2.8	1.5
black	n	69	35
black	percent	12.9	13.1
bmi: 30 to less than 35	n	166	97
bmi: 30 to less than 35	percent	31.0	36.2
bmi: 35 to less than 40	n	116	52
bmi: 35 to less than 40	percent	21.7	19.4
bmi: 40 or more	n	93	41
bmi: 40 or more	percent	17.4	15.3
bmi: less than 30	n	160	78
bmi: less than 30	percent	29.9	29.1
bmi	mean (kg/m2)	34.5	34.1
bmi	sd (kg/m2)	6.9	7.1
female	n	429	205
female	percent	80.2	76.5
hba1c	mean (percent)	5.4	5.4
hba1c	sd (percent)	0.3	0.3
hispanic	n	42	21
hispanic	percent	7.9	7.8
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	0	0
other race other	n	5	3
other race other	percent	0.9	1.1
sbp	mean (mmHg)	121	121
sbp	sd (mmHg)	13	13
waist	mean (cm)	105.5	104.7
waist	sd (cm)	15.9	16.9
weight	mean (kg)	96.5	95.4
weight	sd (kg)	22.5	22.7
white	n	446	226
white	percent	83.4	84.3

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

Percent body weight change after randomization in maintenance trials (10 lines; O12)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	percent change	-8.8 percent				hypothetical; full analysis; R0019147:Abstract
48	A1 vs A2	md	-15.3 percent		-16.5 to -14.1		hypothetical; full analysis; R0019147:Abstract
48	A1	percent change	-7.9 percent				treatment policy; full analysis; R0019147:Abstract
48	A1	percent change	-8.3 percent	8.1		535	treatment policy; full analysis; registry:outcomes
48	A1 vs A2	md	-14.8 percent		-16.0 to -13.5		treatment policy; full analysis; R0019147:Abstract
48	A1	percent change	-8.8 percent	7.8		535	while on treatment; full analysis; registry:outcomes
48	A2	percent change	6.9 percent				treatment policy; full analysis; R0019147:Abstract
48	A2	percent change	6.5 percent				hypothetical; full analysis; R0019147:Abstract
48	A2	percent change	6.5 percent	7.7		268	treatment policy; full analysis; registry:outcomes
48	A2	percent change	6.1 percent	7.7		268	while on treatment; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	change	0.8 points	4.9		515	treatment policy; full analysis; registry:outcomes
48	A2	change	-0.9 points	5.6		245	treatment policy; full analysis; registry:outcomes

Physical functioning (any instrument) (2 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	change	1.0 points	3.8		515	treatment policy; full analysis; registry:outcomes
48	A2	change	-1.2 points	4.5		245	treatment policy; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				41 / 535	not stated; safety; registry:adverse_events
	A2	events				15 / 268	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	2.4		not stated; other; R0019147:Abstract
A1	events		13 / 535	not stated; randomized; registry:flow
A2	events	2.2		not stated; other; R0019147:Abstract
A2	events		6 / 268	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	75 / 535	not stated; safety; registry:adverse_events
A1	events	1 / 535	not stated; safety; registry:adverse_events
A2	events	13 / 268	not stated; safety; registry:adverse_events
A2	events	0 / 268	not stated; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	54 / 535	not stated; safety; registry:adverse_events
A1	events	1 / 535	not stated; safety; registry:adverse_events
A2	events	8 / 268	not stated; safety; registry:adverse_events
A2	events	0 / 268	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				77 / 535	not stated; safety; registry:adverse_events
	A2	events				19 / 268	not stated; safety; registry:adverse_events

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	62 / 535	not stated; safety; registry:adverse_events
A1	events	0 / 535	not stated; safety; registry:adverse_events
A2	events	16 / 268	not stated; safety; registry:adverse_events
A2	events	1 / 268	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (8 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 535	not stated; safety; biliary cyst; registry:adverse_events
A1	events	1 / 535	not stated; safety; cholecystitis; registry:adverse_events
A1	events	5 / 535	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	15 / 535	not stated; randomized; R0013578:Table 1
A2	events	2 / 268	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 268	not stated; safety; biliary cyst; registry:adverse_events
A2	events	10 / 268	not stated; randomized; R0013578:Table 1
A2	events	0 / 268	not stated; safety; cholecystitis; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 535	not stated; safety; intestinal obstruction; registry:adverse_events
	A2	events				1 / 268	not stated; safety; intestinal obstruction; registry:adverse_events