Phase 2 · Semaglutide

NCT02970942 trial results

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

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) (Percentage of participants), After 72 weeks, Yes. Semaglutide 0.1 mg: 40.4; Semaglutide 0.2 mg: 35.6; Semaglutide 0.4 mg: 58.9; Placebo: 17.2.

Participants: 320
Status: completed
Completed: 2020-03-19
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02970942), updated at source Nov 16, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02970942 measured first

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)Percentage of participants · After 72 weeks · number

Measure	Semaglutide 0.1 mgn=57	Semaglutide 0.2 mgn=59	Semaglutide 0.4 mgn=56	Placebon=58
Yes	40.4	35.6	58.9	17.2
No	54.4	47.5	30.4	74.1
Missing	5.3	16.9	10.7	8.6

Side effects by arm

Side effects in NCT02970942

Percent of participants affected, From week 0 to week 79 Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.. The most common events the registry lists.

Event	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Placebo
Any serious event	15%	19.2%	14.8%	10%
Nausea	30%	37.2%	40.7%	11.3%
Diarrhoea	28.8%	28.2%	19.8%	13.8%
Decreased appetite	20%	23.1%	22.2%	5%
Constipation	15%	21.8%	22.2%	12.5%
Vomiting	17.5%	21.8%	14.8%	2.5%
Nasopharyngitis	13.8%	19.2%	12.3%	15%
Headache	8.8%	12.8%	12.3%	10%
Back pain	8.8%	6.4%	12.3%	7.5%
Dyspepsia	5%	11.5%	4.9%	6.3%
Abdominal pain	11.3%	10.3%	7.4%	3.8%
Abdominal distension	1.3%	10.3%	4.9%	5%
Fatigue	8.8%	10.3%	8.6%	8.8%
Abdominal pain upper	6.3%	7.7%	9.9%	3.8%
Arthralgia	0%	5.1%	9.9%	8.8%
Dizziness	7.5%	7.7%	9.9%	7.5%
Lipase increased	5%	9%	1.2%	0%
Sinusitis	5%	9%	2.5%	1.3%
Hyperglycaemia	1.3%	2.6%	3.7%	8.8%
Influenza	8.8%	1.3%	3.7%	7.5%
Urinary tract infection	6.3%	2.6%	8.6%	0%
Eructation	6.3%	7.7%	1.2%	0%
Upper respiratory tract infection	5%	7.7%	3.7%	6.3%
Procedural pain	7.5%	2.6%	2.5%	2.5%
Flatulence	2.5%	6.4%	3.7%	0%
Injection site bruising	1.3%	6.4%	3.7%	2.5%

Secondary outcomes

What else it measured

Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)Percentage of participants · After 72 weeks · number

Measure	Semaglutide 0.1 mgn=57	Semaglutide 0.2 mgn=59	Semaglutide 0.4 mgn=56	Placebon=58
Yes	49.1	32.2	42.9	32.8
No	45.6	50.8	46.4	58.6
Missing	5.3	16.9	10.7	8.6

Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)Percentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	71.3	79.5	82.9	43.8
Worsening	7.5	2.6	3.7	16.3
No change	13.8	5.1	1.2	27.5
Missing	7.5	12.8	12.2	12.5

Percentage of Participants With Change in SteatosisPercentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	52.5	60.3	63.4	26.3
Worsening	6.3	2.6	3.7	15.0
No change	33.8	24.4	20.7	46.3
Missing	7.5	12.8	12.2	12.5

Percentage of Participants With Change in Lobular InflammationPercentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	41.3	47.4	37.8	26.3
Worsening	7.5	7.7	6.1	17.5
No change	43.8	32.1	43.9	45.0
Missing	7.5	12.8	12.2	11.3

Percentage of Participants With Change in Hepatocyte BallooningPercentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	61.3	70.5	74.4	38.8
Worsening	2.5	2.6	1.2	2.5
No change	28.8	14.1	12.2	46.3
Missing	7.5	12.8	12.2	12.5

Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis ClassificationPercentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	46.3	32.1	42.7	31.3
Worsening	10.0	7.7	4.9	18.8
No change	36.3	42.3	36.6	37.5
Missing	7.5	17.9	15.9	12.5

Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) ScorePercentage of participants · Baseline (week 0), Week 72 · number

Measure	Semaglutide 0.1 mgn=80	Semaglutide 0.2 mgn=78	Semaglutide 0.4 mgn=82	Placebon=80
Improvement	62.5	71.8	72.0	42.5
Worsening	7.5	3.8	1.2	11.3
No change	22.5	11.5	14.6	33.8
Missing	7.5	12.8	12.2	12.5

Change in Fibrosis-4 ScoreRatio of fibrosis-4 score · Baseline (week 0), Week 72 · geometric mean

Semaglutide 0.1 mgn=71	Semaglutide 0.2 mgn=63	Semaglutide 0.4 mgn=72	Placebon=67
0.81(36.8)	0.77(32.4)	0.77(31.3)	0.95(43.1)

Change in NAFLD Fibrosis Score (NFS)Score on a scale · Baseline (week 0), Week 72 · mean

Semaglutide 0.1 mgn=71	Semaglutide 0.2 mgn=63	Semaglutide 0.4 mgn=72	Placebon=66
-0.322(0.819)	-0.617(0.691)	-0.475(0.770)	-0.040(0.844)

Change in Alanine Aminotransferase (ALT)Ratio of ALT · Baseline (week 0), Week 72 · geometric mean

Semaglutide 0.1 mgn=76	Semaglutide 0.2 mgn=71	Semaglutide 0.4 mgn=77	Placebon=75
0.62(62.7)	0.57(62.1)	0.40(68.2)	0.80(60.3)

Change in Aspartate Aminotransferase (AST)Ratio of AST · Baseline (week 0), Week 72 · geometric mean

Semaglutide 0.1 mgn=74	Semaglutide 0.2 mgn=69	Semaglutide 0.4 mgn=77	Placebon=74
0.66(55.1)	0.63(46.6)	0.50(45.8)	0.84(62.3)

Change in Gamma Glutamyl Transferase (GGT)Ratio of GGT · Baseline (week 0), Week 72 · geometric mean

Semaglutide 0.1 mgn=76	Semaglutide 0.2 mgn=71	Semaglutide 0.4 mgn=77	Placebon=75
0.76(52.0)	0.64(51.6)	0.48(60.2)	0.92(46.6)

The trial

How NCT02970942 was run

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

Semaglutide 0,1 mg
Semaglutide 0,2 mg
Semaglutide 0,4 mg
Placebo 1
Placebo 2
Placebo 3

Who could join the trial

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence\* or narcotics. (\* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Published papers

Papers from NCT02970942

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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