parallel randomized trial

NCT02970942

This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

Metabolic dysfunction associated steatotic liver disease or steatohepatitis NCT02970942S000922

Design

Randomized: 320
Start year: 2016
Treatment: 72 weeks, follow-up 79 weeks
Countries: multinational (143 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 75; biopsy NASH F1 to F3; NAS 4 or more; BMI above 25; HbA1c 10 percent or less

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Semaglutide 0.1 mg injection once daily Semaglutide 0.1 mg	lifestyle: standard	80	80
A2	Semaglutide 0.2 mg injection once daily Semaglutide 0.2 mg	lifestyle: standard	78	78
A3	Semaglutide 0.4 mg injection once daily Semaglutide 0.4 mg	lifestyle: standard	82	82
A4	Placebo Placebo	lifestyle: standard	80	80

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 0.1 mg injection once daily A1	Semaglutide 0.2 mg injection once daily A2	Semaglutide 0.4 mg injection once daily A3	Placebo A4	Whole trial ALL
age	mean (years)	55.2	58.1	54.3	52.4
age	sd (years)	10.9	9.9	10.2	10.8
asian	n	10	12	14	12
black	n	1	1	0	0
bmi	mean (kg/m2)					35.8
bmi	sd (kg/m2)					6.4
female	n	51	52	47	44
fibrosis stage: F0	n					0
fibrosis stage: F0	percent					0.0
fibrosis stage: F1	n					90
fibrosis stage: F1	percent					28.1
fibrosis stage: F2	n					72
fibrosis stage: F2	percent					22.5
fibrosis stage: F3	n					158
fibrosis stage: F3	percent					49.4
fibrosis stage: F4	n					0
fibrosis stage: F4	percent					0.0
hispanic	n	7	10	14	9
other race american indian alaska native	n	0	1	2	0
other race native hawaiian pacific islander	n	0	0	0	0
other race other	n	0	0	1	1
weight	mean (kg)					98.4
weight	sd (kg)					21.7
white	n	65	59	62	62

Analyses this trial contributes to

Results

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

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 80	while on treatment; safety; registry:adverse_events
A2	events	2 / 78	while on treatment; safety; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; registry:adverse_events

SF-36 physical component summary change (4 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
72	A1	change	2.1 points	7.0	80	treatment policy; full analysis; registry:outcomes
72	A2	change	1.1 points	7.3	78	treatment policy; full analysis; registry:outcomes
72	A3	change	3.9 points	7.1	82	treatment policy; full analysis; registry:outcomes
72	A4	change	-0.1 points	8.3	80	treatment policy; full analysis; registry:outcomes

Physical functioning (any instrument) (4 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
72	A1	change	1.8 points	7.8	80	treatment policy; full analysis; registry:outcomes
72	A2	change	2.0 points	7.3	78	treatment policy; full analysis; registry:outcomes
72	A3	change	2.8 points	7.8	82	treatment policy; full analysis; registry:outcomes
72	A4	change	-0.4 points	8.2	80	treatment policy; full analysis; registry:outcomes

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	12 / 80	while on treatment; safety; registry:adverse_events
A2	events	15 / 78	while on treatment; safety; registry:adverse_events
A3	events	12 / 81	while on treatment; safety; registry:adverse_events
A4	events	8 / 80	while on treatment; safety; registry:adverse_events

Nausea (8 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	24 / 80	while on treatment; safety; registry:adverse_events
A1	events	0 / 80	while on treatment; safety; registry:adverse_events
A2	events	29 / 78	while on treatment; safety; registry:adverse_events
A2	events	0 / 78	while on treatment; safety; registry:adverse_events
A3	events	33 / 81	while on treatment; safety; registry:adverse_events
A3	events	1 / 81	while on treatment; safety; registry:adverse_events
A4	events	9 / 80	while on treatment; safety; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	14 / 80	while on treatment; safety; registry:adverse_events
A2	events	17 / 78	while on treatment; safety; registry:adverse_events
A3	events	12 / 81	while on treatment; safety; registry:adverse_events
A4	events	2 / 80	while on treatment; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	23 / 80	while on treatment; safety; registry:adverse_events
A2	events	22 / 78	while on treatment; safety; registry:adverse_events
A3	events	16 / 81	while on treatment; safety; registry:adverse_events
A4	events	11 / 80	while on treatment; safety; registry:adverse_events

Constipation (8 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	12 / 80	while on treatment; safety; registry:adverse_events
A1	events	1 / 80	while on treatment; safety; registry:adverse_events
A2	events	17 / 78	while on treatment; safety; registry:adverse_events
A2	events	0 / 78	while on treatment; safety; registry:adverse_events
A3	events	18 / 81	while on treatment; safety; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; registry:adverse_events
A4	events	10 / 80	while on treatment; safety; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 80	while on treatment; safety; registry:outcomes
A2	events	6 / 78	while on treatment; safety; registry:outcomes
A3	events	2 / 81	while on treatment; safety; registry:outcomes
A4	events	0 / 80	while on treatment; safety; registry:outcomes

Gallbladder and biliary disease (12 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 80	while on treatment; safety; cholangitis acute; registry:adverse_events
A1	events	1 / 80	while on treatment; safety; cholelithiasis; registry:adverse_events
A1	events	1 / 80	while on treatment; safety; cholecystitis; registry:adverse_events
A2	events	1 / 78	while on treatment; safety; cholangitis acute; registry:adverse_events
A2	events	1 / 78	while on treatment; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 78	while on treatment; safety; cholecystitis; registry:adverse_events
A3	events	1 / 81	while on treatment; safety; cholecystitis; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; cholangitis acute; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; cholangitis acute; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; cholecystitis; registry:adverse_events

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 80	while on treatment; safety; suicidal ideation; registry:adverse_events
A2	events	0 / 78	while on treatment; safety; suicidal ideation; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; suicidal ideation; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; suicidal ideation; registry:adverse_events

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 80	while on treatment; safety; registry:adverse_events
A2	events	0 / 78	while on treatment; safety; registry:adverse_events
A3	events	0 / 81	while on treatment; safety; registry:adverse_events
A4	events	0 / 80	while on treatment; safety; registry:adverse_events

Resolution of steatohepatitis without worsening of fibrosis (4 lines; O60)

Week	Arm	Statistic	Estimate	Events / N	Detail
72	A1	responders	40.4	57	treatment policy; other; registry:outcomes
72	A2	responders	35.6	59	treatment policy; other; registry:outcomes
72	A3	responders	58.9	56	treatment policy; other; registry:outcomes
72	A4	responders	17.2	58	treatment policy; other; registry:outcomes

Fibrosis improvement without worsening of steatohepatitis (4 lines; O61)

Week	Arm	Statistic	Estimate	Events / N	Detail
72	A1	responders	49.1	57	treatment policy; other; registry:outcomes
72	A2	responders	32.2	59	treatment policy; other; registry:outcomes
72	A3	responders	42.9	56	treatment policy; other; registry:outcomes
72	A4	responders	32.8	58	treatment policy; other; registry:outcomes