parallel randomized trial

S003431

Design

Randomized: 60
Start year
Treatment: 24 weeks, follow-up 48 weeks
Countries
Sponsor: (not reported)
Eligibility: age 12 to 17; BMI 85th percentile or higher; MRI-PDFF 8 percent or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lifestyle intervention (randomized arm) Intensive family supported lifestyle intervention	lifestyle: intensive	30
A2	liraglutide or semaglutide GLP-1RA plus brief lifestyle advice	lifestyle: standard	30

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

Characteristic	Statistic	Lifestyle intervention (randomized arm) A1	GLP-1RA plus brief lifestyle advice A2
age	mean (years)	14.6	14.4
age	sd (years)	1.7	1.8
bmi sds	mean	2.12	2.10
bmi sds	sd	0.29	0.27
other male	n	16	17
other male	percent	53.3	56.7
other mri pdff	mean (percent)	15.4	15.8
other mri pdff	sd (percent)	4.9	5.2
waist	mean (cm)	97.6	98.1
waist	sd (cm)	9.4	10.2

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

BMI standard deviation score change (2 lines; O13A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.15 SDS	0.22		30	not stated; randomized; R0040603:Table 2
24	A2	change	-0.38 SDS	0.16		30	not stated; randomized; R0040603:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 /	not stated; other; R0040603:Table 3
	A2	events				1 /	not stated; other; R0040603:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0040603:Results
	A2	events				0 /	not stated; other; R0040603:Results