parallel randomized trial

NCT03357380

A Trial Investigating the Effect of Subcutaneous Semaglutide on Liver Fibrosis Assessed by Magnetic Resonance Elastography in Subjects With Non-alcoholic Fatty Liver Disease

Metabolic dysfunction associated steatotic liver disease or steatohepatitis NCT03357380S000576

Design

Randomized: 67
Start year: 2017
Treatment: 72 weeks, follow-up 79 weeks
Countries: Germany (2 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 75; BMI 25 to 40; MRE stiffness 2.50 to 4.63 kPa; MRI PDFF 10 percent or more; HbA1c 9.5 or less

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 0.4 mg injection once daily Semaglutide 0.4 mg once daily	lifestyle: not reported	34	34
A2	Placebo Placebo	lifestyle: not reported	33	33

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 0.4 mg injection once daily A1	Placebo A2
age	mean (years)	59.5	60.5
age	sd (years)	10.1	8.5
bmi: 25 to less than 30	n	2	2
bmi: 25 to less than 30	percent	5.9	6.1
bmi: 30 to less than 35	n	15	21
bmi: 30 to less than 35	percent	44.1	63.6
bmi: 35 or more	n	17	10
bmi: 35 or more	percent	50.0	30.3
female	n	11	9
female	percent	32.4	27.3
hba1c t2d:no	mean (percent)	6.0	5.9
hba1c t2d:no	sd (percent)	0.5	0.3
hba1c t2d:yes	mean (percent)	7.3	7.4
hba1c t2d:yes	sd (percent)	0.9	1.0
weight	mean (kg)	105.1	102.3
weight	sd (kg)	15.3	12.7
white	n	34	33
white	percent	100	100

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-1.03 percent		28	not stated; full analysis; t2d:yes; R0011165:Table 2
24	A1 vs A2	md	-1.08 percent	-1.44 to -0.72		not stated; full analysis; t2d:yes; R0011165:Table 2
24	A2	change	0.05 percent		21	not stated; full analysis; t2d:yes; R0011165:Table 2
48	A1	change	-1.01 percent		28	not stated; full analysis; t2d:yes; R0011165:Table 2
48	A1 vs A2	md	-0.97 percent	-1.34 to -0.60		not stated; full analysis; t2d:yes; R0011165:Table 2
48	A2	change	-0.05 percent		21	not stated; full analysis; t2d:yes; R0011165:Table 2
72	A1	change	-1.03 percent		28	not stated; full analysis; t2d:yes; R0011165:Table 2
72	A1 vs A2	md	-1.00 percent	-1.38 to -0.62		not stated; full analysis; t2d:yes; R0011165:Table 2
72	A2	change	-0.03 percent		21	not stated; full analysis; t2d:yes; R0011165:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	14.8			4 /	while on treatment; safety; t2d:yes; R0011165:Results
	A2	events	9.5			2 /	while on treatment; safety; t2d:yes; R0011165:Results

Percent body weight change (9 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	percent change	-8.34 percent		34	not stated; full analysis; R0011165:Table 2
24	A1 vs A2	md	-8.09 percent	-9.99 to -6.20		not stated; full analysis; R0011165:Table 2
24	A2	percent change	-0.25 percent		33	not stated; full analysis; R0011165:Table 2
48	A1	percent change	-11.18 percent		34	not stated; full analysis; R0011165:Table 2
48	A1 vs A2	md	-10.52 percent	-13.40 to -7.65		not stated; full analysis; R0011165:Table 2
48	A2	percent change	-0.65 percent		33	not stated; full analysis; R0011165:Table 2
72	A1	percent change	-10.83 percent		34	not stated; full analysis; R0011165:Table 2
72	A1 vs A2	md	-9.68 percent	-12.58 to -6.77		not stated; full analysis; R0011165:Table 2
72	A2	percent change	-1.15 percent		33	not stated; full analysis; R0011165:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				0 / 33	while on treatment; safety; R0011165:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				3 / 33	while on treatment; safety; R0011165:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				0 / 33	while on treatment; safety; R0011165:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				3 / 33	while on treatment; safety; R0011165:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				0 / 33	while on treatment; safety; R0011165:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				8 / 33	while on treatment; safety; R0011165:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 33	while on treatment; safety; R0011165:Table 3
	A2	events				2 / 33	while on treatment; safety; R0011165:Table 3