parallel randomized trial

NCT04102189

Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity

Design

Randomized: 201
Start year: 2019
Treatment: 68 weeks, follow-up 75 weeks
Countries: multinational (37 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 12 to under 18; BMI 95th percentile or more, or 85th with a comorbidity

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg weekly	lifestyle: not reported	134	134
A2	Placebo Placebo	lifestyle: not reported	67	67

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)	15.5	15.3
age	sd (years)	1.5	1.6
asian	n	3	1
black	n	11	5
female	n	84	41
hispanic	n	14	8
other race american indian alaska native	n	2	0
other race other	n	14	6
white	n	104	55

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

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	percent change	-14.8 percent	13.2		131	treatment policy; full analysis; registry:outcomes
68	A2	percent change	2.3 percent	9.1		62	treatment policy; full analysis; registry:outcomes

BMI standard deviation score change (2 lines; O13A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	change	-1.1 SDS	0.9		131	treatment policy; full analysis; registry:outcomes
68	A2	change	-0.1 SDS	0.5		62	treatment policy; full analysis; registry:outcomes

Percent BMI change (3 lines; O13B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1 vs A2	md	-16.75 percent		-20.27 to -13.23		treatment policy; full analysis; registry:outcomes
68	A1	percent change	-16.2 percent	12.9		131	treatment policy; full analysis; registry:outcomes
68	A2	percent change	-0.1 percent	8.6		62	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				15 / 133	not stated; safety; registry:adverse_events
	A2	events				6 / 67	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				56 / 133	not stated; safety; registry:adverse_events
	A2	events				12 / 67	not stated; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 133	not stated; safety; registry:adverse_events
A1	events	48 / 133	not stated; safety; registry:adverse_events
A2	events	7 / 67	not stated; safety; registry:adverse_events
A2	events	0 / 67	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 133	not stated; safety; registry:adverse_events
	A2	events				13 / 67	not stated; safety; registry:adverse_events

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	8 / 133	not stated; safety; registry:adverse_events
A1	events	1 / 133	not stated; safety; post procedural constipation; registry:adverse_events
A2	events	1 / 67	not stated; safety; registry:adverse_events
A2	events	0 / 67	not stated; safety; post procedural constipation; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 133	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	3 / 133	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 67	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 67	not stated; safety; cholelithiasis; registry:adverse_events