parallel randomized trial

STEP 6

Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity

Overweight or obesity without diabetes (adults)NCT03811574S002102

Design

Randomized: 401
Start year: 2019
Treatment: 68 weeks, follow-up 75 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Semaglutide 1.7 mg injection once weekly Semaglutide 1.7 mg	lifestyle: not reported	101	98
A2	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	lifestyle: not reported	199	193
A3	Placebo Placebo	lifestyle: not reported	101	100

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 1.7 mg injection once weekly A1	Semaglutide 2.4 mg subcutaneous once weekly A2	Placebo A3	Whole trial ALL
age	mean (years)	51	52	50	51
age	sd (years)	10	12	9	11
asian	n	101	199	101	401
black	n				0
female	n	37	85	26	148
hispanic	n				0
white	n				0

Analyses this trial contributes to

Results

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

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Events / N	Detail
68	A1	responders	24 / 25	not stated; full analysis; t2d:yes; registry:outcomes
68	A2	responders	43 / 49	not stated; full analysis; t2d:yes; registry:outcomes
68	A3	responders	1 / 25	not stated; full analysis; t2d:yes; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 25	not stated; safety; t2d:yes; registry:outcomes
A2	events	0 / 49	not stated; safety; t2d:yes; registry:outcomes
A3	events	0 / 25	not stated; safety; t2d:yes; registry:outcomes

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
68	A1	change	-12 mmHg	13	98	not stated; full analysis; registry:outcomes
68	A2	change	-11 mmHg	15	193	not stated; full analysis; registry:outcomes
68	A3	change	-5 mmHg	15	100	not stated; full analysis; registry:outcomes

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	percent change	-9.9 percent	7.8		98	not stated; full analysis; registry:outcomes
68	A1 vs A3	md	-7.52 percent		-9.62 to -5.43		not stated; full analysis; registry:outcomes
68	A2	percent change	-13.4 percent	8.6		193	not stated; full analysis; registry:outcomes
68	A2 vs A3	md	-11.06 percent		-12.88 to -9.24		not stated; full analysis; registry:outcomes
68	A3	percent change	-1.9 percent	5.9		100	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
68	A1	responders			71 / 98	not stated; full analysis; registry:outcomes
68	A1 vs A3	or	11.08	5.53 to 22.22		not stated; full analysis; registry:outcomes
68	A2	responders			160 / 193	not stated; full analysis; registry:outcomes
68	A2 vs A3	or	21.72	11.27 to 41.86		not stated; full analysis; registry:outcomes
68	A3	responders			21 / 100	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Events / N	Detail
68	A1	responders	41 / 98	not stated; full analysis; registry:outcomes
68	A2	responders	117 / 193	not stated; full analysis; registry:outcomes
68	A3	responders	5 / 100	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Events / N	Detail
68	A1	responders	24 / 98	not stated; full analysis; registry:outcomes
68	A2	responders	79 / 193	not stated; full analysis; registry:outcomes
68	A3	responders	3 / 100	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Events / N	Detail
68	A1	responders	11 / 98	not stated; full analysis; registry:outcomes
68	A2	responders	38 / 193	not stated; full analysis; registry:outcomes
68	A3	responders	2 / 100	not stated; full analysis; registry:outcomes

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 100	not stated; safety; registry:adverse_events
A2	events	0 / 199	not stated; safety; registry:adverse_events
A3	events	0 / 101	not stated; safety; registry:adverse_events

SF-36 physical component summary change (3 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
68	A1	change	-0.8 points	6.0	98	not stated; full analysis; registry:outcomes
68	A2	change	0.7 points	4.4	192	not stated; full analysis; registry:outcomes
68	A3	change	0.1 points	5.3	100	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (6 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
68	A1	change	2.6 points	16.3	98	not stated; full analysis; registry:outcomes
68	A1	change	0.0 points	5.7	98	not stated; full analysis; registry:outcomes
68	A2	change	4.9 points	15.1	192	not stated; full analysis; registry:outcomes
68	A2	change	1.0 points	3.7	192	not stated; full analysis; registry:outcomes
68	A3	change	0.5 points	12.7	100	not stated; full analysis; registry:outcomes
68	A3	change	-0.5 points	3.9	100	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
68	A1	change	3.5 points	11.0	98	not stated; full analysis; registry:outcomes
68	A2	change	4.8 points	11.8	192	not stated; full analysis; registry:outcomes
68	A3	change	-0.5 points	10.3	100	not stated; full analysis; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	7 / 100	not stated; safety; registry:adverse_events
A2	events	10 / 199	not stated; safety; registry:adverse_events
A3	events	7 / 101	not stated; safety; registry:adverse_events

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	18 / 100	not stated; safety; registry:adverse_events
A2	events	35 / 199	not stated; safety; registry:adverse_events
A3	events	4 / 101	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	10 / 100	not stated; safety; registry:adverse_events
A2	events	17 / 199	not stated; safety; registry:adverse_events
A3	events	2 / 101	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	22 / 100	not stated; safety; registry:adverse_events
A2	events	32 / 199	not stated; safety; registry:adverse_events
A3	events	6 / 101	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	19 / 100	not stated; safety; registry:adverse_events
A2	events	52 / 199	not stated; safety; registry:adverse_events
A3	events	3 / 101	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (3 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 100	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	2 / 199	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 101	not stated; safety; cholelithiasis; registry:adverse_events

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 100	not stated; safety; intestinal obstruction; registry:adverse_events
A2	events	0 / 199	not stated; safety; intestinal obstruction; registry:adverse_events
A3	events	1 / 101	not stated; safety; intestinal obstruction; registry:adverse_events