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Clinical Trial Results:
Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator

Summary
EudraCT number	2014-001540-38
Trial protocol	BE DE GB
Global end of trial date	12 Apr 2017

Results information
Results version number	v1(current)
This version publication date	22 Apr 2018
First version publication date	22 Apr 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

NN9536-4153

ISRCTN number

US NCT number

NCT02453711

WHO universal trial number (UTN)

U1111-1155-4660

Sponsor organisation name

Novo Nordisk A/S

Sponsor organisation address

Novo Allé, Bagsvaerd, Denmark, 2880

Public contact

Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Scientific contact

Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Oct 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Mar 2017

Global end of trial reached?

Yes

Global end of trial date

12 Apr 2017

Was the trial ended prematurely?

Main objective of the trial

To assess and compare the dose-response of five doses of once-daily semaglutide versus placebo in inducing and maintaining weight loss after 52 weeks in obese subjects without diabetes mellitus

Protection of trial subjects

The trial was conducted in accordance with the Declaration of Helsinki (October 2013), ICH Good Clinical Practice (June 1996), Europäische Norm (EN) International Organization for Standardization (ISO) 14155 Part 1 and 2 and 21 United States (US) Code of Federal Regulations (CFR) 312.120.

Background therapy

Not applicable.

Evidence for comparator

Not applicable.

Actual start date of recruitment

01 Oct 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 56

Country: Number of subjects enrolled

Belgium: 96

Country: Number of subjects enrolled

Canada: 75

Country: Number of subjects enrolled

Germany: 69

Country: Number of subjects enrolled

Israel: 83

Country: Number of subjects enrolled

Russian Federation: 124

Country: Number of subjects enrolled

United Kingdom: 113

Country: Number of subjects enrolled

United States: 341

Worldwide total number of subjects

957

EEA total number of subjects

278

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

882

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The trial was conducted at 71 sites in 8 countries as follows: Australia: 5, Belgium: 5, Canada: 9, Germany: 6, Israel: 7, Russian Federation: 10, United Kingdom (UK): 8, United States (US): 21. Along with this, recruitment of subjects was planned at 3 sites (1 each in Germany, Russian Federation, and US), but where no subjects were screened.

Screening details

Design:Subjects were randomised to 1 of the 16 parallel treatment arms in a 6:1 ratio (active:placebo) to receive either: A)Semaglutide 0.05/0.1/0.2/0.3/0.4 mg; dose escalation every fourth week B)Semaglutide 0.3/0.4 mg; dose escalation every second week C)Liraglutide 3.0 mg;dose escalation every week D)Placebo;matching each of the active treatment

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Subjects were centrally randomised to 1 of the 16 parallel treatment arms using interactive web response system (IWRS). Semaglutide and corresponding placebo as well as liraglutide and corresponding placebo were supplied in similar pen systems and were by all means visually identical and were packed and labelled to fulfil the requirements for double-blind procedures. Furthermore, equal volumes of active substance and placebo were administered during treatment ensuring blinding within dose level

Are arms mutually exclusive

Yes

Semaglutide 0.05 mg

Arm description

Subjects received once daily semaglutide 0.05 mg subcutaneous (s.c.; under the skin) injections for 52 weeks.

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.1 mg

Arm description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.2 mg

Arm description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.3 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.4 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.3 mg (fast escalation)

Arm description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Semaglutide 0.4 mg (fast escalation)

Arm description

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide 1.0 mg/mL injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Liraglutide 3.0 mg

Arm description

Subjects received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.

Arm type

Active comparator

Investigational medicinal product name

Liraglutide

Investigational medicinal product code

Other name

Saxenda®

Pharmaceutical forms

Solution for injection in pre-filled pen

Routes of administration

Subcutaneous use

Dosage and administration details

Liraglutide 6.0 mg/mL injections were administered using pre-filled PDS290 pen-injector in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Placebo pool

Arm description

Subjects received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).

Arm type

Placebo

Investigational medicinal product name

Semaglutide placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Semaglutide placebo injections were administered using NovoPen® 4 in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Investigational medicinal product name

Liraglutide placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled pen

Routes of administration

Subcutaneous use

Dosage and administration details

Liraglutide placebo injections were administered using pre-filled PDS290 pen-injector in the thigh, abdomen or upper arm daily and were to the extent possible to be administered on the same time every day.

Number of subjects in period 1	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Started	103	102	103	103	102	102	103	103	136
Completed	92	95	94	96	100	96	100	96	123
Not completed	11	7	9	7	2	6	3	7	13
Adverse event, serious fatal	-	-	-	-	-	-	1	-	-
Consent withdrawn by subject	5	4	6	4	1	1	-	1	7
Unclassified	1	-	1	-	-	-	-	-	-
Lost to follow-up	5	3	2	3	1	5	2	6	6

Baseline characteristics

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Reporting group title

Semaglutide 0.05 mg

Reporting group description

Subjects received once daily semaglutide 0.05 mg subcutaneous (s.c.; under the skin) injections for 52 weeks.

Reporting group title

Semaglutide 0.1 mg

Reporting group description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).

Reporting group title

Semaglutide 0.2 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg

Reporting group description

Reporting group title

Semaglutide 0.4 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg (fast escalation)

Reporting group description

Reporting group title

Semaglutide 0.4 mg (fast escalation)

Reporting group description

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo pool

Reporting group description

Reporting group values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool	Total
Number of subjects	103	102	103	103	102	102	103	103	136	957
Age Categorical
Results are based on the full analysis set (FAS), which included all randomised subjects.
Units: Subjects
Adults (18-64 years)	93	93	99	97	86	95	95	97	127	882
From 65-84 years	10	9	4	6	16	7	7	6	9	74
85 years and over	0	0	0	0	0	0	1	0	0	1
Age Continuous
Results are based on the FAS.
Units: years
arithmetic mean (standard deviation)	46.97 ± 12.80	45.24 ± 12.62	44.37 ± 11.24	46.73 ± 12.02	48.37 ± 13.44	47.10 ± 12.05	46.07 ± 13.51	48.50 ± 11.22	46.42 ± 12.80	-
Gender Categorical
Results are based on the FAS.
Units: Subjects
Female	67	66	66	66	66	66	67	67	88	619
Male	36	36	37	37	36	36	36	36	48	338
Body weight
Results are based on the FAS.
Units: Kg
arithmetic mean (standard deviation)	111.29 ± 23.17	111.31 ± 21.47	114.49 ± 24.53	111.51 ± 22.96	113.20 ± 26.42	108.11 ± 22.08	109.56 ± 21.33	108.71 ± 21.94	114.19 ± 25.37	-
Glycosylated haemoglobin (HbA1c)
Results are based on the FAS. Number of subjects analysed in ‘Semaglutide 0.1 mg treatment arm’ = 101.
Units: Percentage (%) of HbA1c
arithmetic mean (standard deviation)	5.51 ± 0.35	5.45 ± 0.43	5.41 ± 0.39	5.51 ± 0.38	5.47 ± 0.42	5.48 ± 0.41	5.49 ± 0.42	5.53 ± 0.38	5.54 ± 0.38	-
Fasting plasma glucose (FPG)
Results are based on the FAS. Number of subjects analysed in ‘Semaglutide 0.4 mg treatment arm’ = 101.
Units: mmol/L
arithmetic mean (standard deviation)	5.48 ± 0.64	5.48 ± 0.55	5.41 ± 0.77	5.48 ± 0.73	5.40 ± 0.67	5.43 ± 0.64	5.54 ± 0.87	5.55 ± 0.73	5.50 ± 0.62	-

End points

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Reporting group title

Semaglutide 0.05 mg

Reporting group description

Subjects received once daily semaglutide 0.05 mg subcutaneous (s.c.; under the skin) injections for 52 weeks.

Reporting group title

Semaglutide 0.1 mg

Reporting group description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).

Reporting group title

Semaglutide 0.2 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg

Reporting group description

Reporting group title

Semaglutide 0.4 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg (fast escalation)

Reporting group description

Reporting group title

Semaglutide 0.4 mg (fast escalation)

Reporting group description

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo pool

Reporting group description

Primary: Relative change from baseline in body weight (%)

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End point title

Relative change from baseline in body weight (%)

End point description

Relative change from baseline (week 0) in body weight was evaluated after 52 weeks of treatment. Results are based on the full analysis set (FAS), which included all randomised subjects. Number of subjects analysed = number of subjects contributed to the analysis. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate.

End point type

Primary

End point timeframe

At 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	92	96	94	95	100	95	100	96	123
Units: Percentage (%)
number (not applicable)	-5.99	-8.62	-11.60	-11.17	-13.84	-11.38	-16.29	-7.76	-2.29

Semaglutide 0.05 mg versus Placebo Pool

Statistical analysis description

J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons. The following ‘comparison groups’ should be read as 'semaglutide 0.05 mg - placebo pool'.

Comparison groups

Semaglutide 0.05 mg v Placebo pool

Number of subjects included in analysis

215

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0055

Method

ANCOVA

Parameter type

Treatment difference (%-points)

Point estimate

-3.7

Confidence interval

level

95%

sides

2-sided

lower limit

-6.55

upper limit

-0.85

Semaglutide 0.1 mg versus placebo pool

Statistical analysis description

Comparison groups

Semaglutide 0.1 mg v Placebo pool

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

ANCOVA

Parameter type

Treatment difference (%-points)

Point estimate

-6.32

Confidence interval

level

95%

sides

2-sided

lower limit

-9.16

upper limit

-3.49

Semaglutide 0.2 mg versus placebo pool

Statistical analysis description

Comparison groups

Semaglutide 0.2 mg v Placebo pool

Number of subjects included in analysis

217

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

ANCOVA

Parameter type

Treatment difference (%-points)

Point estimate

-9.31

Confidence interval

level

95%

sides

2-sided

lower limit

-12.15

upper limit

-6.46

Semaglutide 0.3 mg versus placebo pool

Statistical analysis description

Comparison groups

Semaglutide 0.3 mg v Placebo pool

Number of subjects included in analysis

218

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

ANCOVA

Parameter type

Treatment difference (%-points)

Point estimate

-8.88

Confidence interval

level

95%

sides

2-sided

lower limit

-11.72

upper limit

-6.03

Semaglutide 0.4 mg versus placebo pool

Statistical analysis description

Comparison groups

Semaglutide 0.4 mg v Placebo pool

Number of subjects included in analysis

223

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

ANCOVA

Parameter type

Treatment difference (%-points)

Point estimate

-11.55

Confidence interval

level

95%

sides

2-sided

lower limit

-14.38

upper limit

-8.72

Secondary: Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

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End point title

Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

End point description

Proportion of subjects who lost more than or equal to 5% of their baseline (week 0) body weight was evaluated after 52 weeks of treatment. Results are based on the FAS, which included all randomised subjects. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate.

End point type

Secondary

End point timeframe

At 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	92	96	94	95	100	95	100	96	123
Units: Percentage (%) of subjects
number (not applicable)	53.50	67.49	74.91	80.52	82.52	72.19	89.58	66.12	22.87

No statistical analyses for this end point

Secondary: Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

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End point title

Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

End point description

Proportion of subjects who lost more than or equal to 10% of their baseline (week 0) body weight was evaluated after 52 weeks of treatment. Results are based on the FAS, which included all randomised subjects. Number of subjects analysed = number of subjects contributed to the analysis. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate.

End point type

Secondary

End point timeframe

At 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	92	96	94	95	100	95	100	96	123
Units: Percentage (%) of subjects
number (not applicable)	18.94	36.57	55.95	57.76	64.61	58.45	71.91	33.98	10.08

No statistical analyses for this end point

Secondary: Change in body weight (kg)

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End point title

Change in body weight (kg)

End point description

Change from baseline (week 0) in body weight was evaluated after 52 weeks of treatment. Results are based on the FAS, which included all randomised subjects. Number of subjects analysed = number of subjects contributed to the analysis. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate.

End point type

Secondary

End point timeframe

From baseline to 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	92	96	94	95	100	95	100	96	123
Units: Kg
number (not applicable)	-6.66	-9.34	-12.30	-12.45	-15.15	-12.54	-17.36	-8.47	-2.48

No statistical analyses for this end point

Secondary: Change in glycosylated haemoglobin (HbA1c)

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End point title

Change in glycosylated haemoglobin (HbA1c)

End point description

Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment. Results are based on the FAS, which included all randomised subjects. Number of subjects analysed = number of subjects contributed to the analysis. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate.

End point type

Secondary

End point timeframe

From baseline to 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	77	88	87	87	82	75	91	85	103
Units: Percentage (%) of HbA1c
number (not applicable)	-0.13	-0.21	-0.28	-0.23	-0.29	-0.25	-0.34	-0.21	-0.01

No statistical analyses for this end point

Secondary: Change in fasting plasma glucose (FPG)

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End point title

Change in fasting plasma glucose (FPG)

End point description

Change from baseline (week 0) in FPG was evaluated after 52 weeks of treatment. Results are based on the FAS, which included all randomised subjects. Number of subjects analysed = number of subjects contributed to the analysis. Following mentioned ‘measure type’ should be read as ‘Least Square Mean’. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate.

End point type

Secondary

End point timeframe

From baseline to 52 weeks

End point values	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Number of subjects analysed	77	88	86	88	81	75	91	86	103
Units: mmol/L
number (not applicable)	-0.29	-0.35	-0.40	-0.39	-0.43	-0.38	-0.51	-0.35	0.01

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Week 0 up to Week 59 (treatment period: week 0 to week 52 + follow-up period: week 53 to week 59). Number of deaths causally related to treatment’ is the data considered to present under ‘total number of deaths resulting from adverse events’.

Adverse event reporting additional description

All AEs mentioned here are treatment-emergent adverse events (TEAEs), which was defined as any AE reported after first trial product administration and until last trial product administration with a 7-week follow-up period. Results are based on the safety analysis set, which included all subjects receiving at least 1 dose of randomised treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Semaglutide 0.05 mg

Reporting group description

Subjects received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.

Reporting group title

Semaglutide 0.1 mg

Reporting group description

Subjects received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).

Reporting group title

Semaglutide 0.2 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg

Reporting group description

Reporting group title

Semaglutide 0.4 mg

Reporting group description

Reporting group title

Semaglutide 0.3 mg (fast escalation)

Reporting group description

Reporting group title

Semaglutide 0.4 mg (fast escalation)

Reporting group description

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo pool

Reporting group description

Serious adverse events	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Total subjects affected by serious adverse events
subjects affected / exposed	13 / 103 (12.62%)	8 / 102 (7.84%)	5 / 103 (4.85%)	6 / 103 (5.83%)	13 / 102 (12.75%)	6 / 102 (5.88%)	7 / 103 (6.80%)	4 / 103 (3.88%)	11 / 136 (8.09%)
number of deaths (all causes)	0	0	0	0	0	0	1	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular insufficiency
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Cardiac pacemaker insertion
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrectomy
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Percutaneous coronary intervention
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Food allergy
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Endometrial hyperplasia
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Human chorionic gonadotropin increased
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle enzyme increased
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal anastomotic leak
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Very long-chain acyl-coenzyme A dehydrogenase deficiency
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cauda equina syndrome
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vestibular disorder
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal scarring
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	2 / 102 (1.96%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	3 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	1 / 102 (0.98%)	3 / 102 (2.94%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 1	2 / 3	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Hand dermatitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Livedo reticularis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 103 (0.00%)	2 / 102 (1.96%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	3 / 103 (2.91%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 103 (0.97%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 136 (0.74%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterocolitis infectious
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	1 / 103 (0.97%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	1 / 102 (0.98%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 136 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	0 / 102 (0.00%)	0 / 102 (0.00%)	0 / 103 (0.00%)	0 / 103 (0.00%)	2 / 136 (1.47%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Semaglutide 0.05 mg	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.3 mg	Semaglutide 0.4 mg	Semaglutide 0.3 mg (fast escalation)	Semaglutide 0.4 mg (fast escalation)	Liraglutide 3.0 mg	Placebo pool
Total subjects affected by non serious adverse events
subjects affected / exposed	83 / 103 (80.58%)	87 / 102 (85.29%)	84 / 103 (81.55%)	85 / 103 (82.52%)	90 / 102 (88.24%)	91 / 102 (89.22%)	88 / 103 (85.44%)	83 / 103 (80.58%)	87 / 136 (63.97%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 103 (0.00%)	6 / 102 (5.88%)	1 / 103 (0.97%)	0 / 103 (0.00%)	5 / 102 (4.90%)	0 / 102 (0.00%)	3 / 103 (2.91%)	1 / 103 (0.97%)	1 / 136 (0.74%)
occurrences all number	0	6	1	0	7	0	3	1	1
Lipase increased
subjects affected / exposed	2 / 103 (1.94%)	2 / 102 (1.96%)	2 / 103 (1.94%)	0 / 103 (0.00%)	6 / 102 (5.88%)	4 / 102 (3.92%)	1 / 103 (0.97%)	3 / 103 (2.91%)	1 / 136 (0.74%)
occurrences all number	2	2	2	0	7	4	1	4	1
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	4 / 103 (3.88%)	1 / 102 (0.98%)	2 / 103 (1.94%)	3 / 103 (2.91%)	4 / 102 (3.92%)	2 / 102 (1.96%)	1 / 103 (0.97%)	0 / 103 (0.00%)	7 / 136 (5.15%)
occurrences all number	4	1	2	3	5	2	1	0	14
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 103 (2.91%)	6 / 102 (5.88%)	9 / 103 (8.74%)	4 / 103 (3.88%)	9 / 102 (8.82%)	8 / 102 (7.84%)	7 / 103 (6.80%)	7 / 103 (6.80%)	2 / 136 (1.47%)
occurrences all number	3	6	9	4	11	9	8	8	2
Headache
subjects affected / exposed	7 / 103 (6.80%)	15 / 102 (14.71%)	10 / 103 (9.71%)	10 / 103 (9.71%)	20 / 102 (19.61%)	14 / 102 (13.73%)	11 / 103 (10.68%)	15 / 103 (14.56%)	15 / 136 (11.03%)
occurrences all number	9	20	12	12	31	17	13	22	19
General disorders and administration site conditions
Early satiety
subjects affected / exposed	3 / 103 (2.91%)	4 / 102 (3.92%)	5 / 103 (4.85%)	3 / 103 (2.91%)	6 / 102 (5.88%)	3 / 102 (2.94%)	3 / 103 (2.91%)	4 / 103 (3.88%)	2 / 136 (1.47%)
occurrences all number	3	4	5	3	6	3	3	4	2
Fatigue
subjects affected / exposed	4 / 103 (3.88%)	7 / 102 (6.86%)	7 / 103 (6.80%)	7 / 103 (6.80%)	13 / 102 (12.75%)	9 / 102 (8.82%)	7 / 103 (6.80%)	5 / 103 (4.85%)	9 / 136 (6.62%)
occurrences all number	4	7	7	7	15	10	7	6	9
Injection site bruising
subjects affected / exposed	3 / 103 (2.91%)	5 / 102 (4.90%)	5 / 103 (4.85%)	5 / 103 (4.85%)	6 / 102 (5.88%)	5 / 102 (4.90%)	6 / 103 (5.83%)	4 / 103 (3.88%)	9 / 136 (6.62%)
occurrences all number	4	5	8	10	6	5	8	4	27
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 103 (0.00%)	3 / 102 (2.94%)	6 / 103 (5.83%)	2 / 103 (1.94%)	3 / 102 (2.94%)	6 / 102 (5.88%)	4 / 103 (3.88%)	3 / 103 (2.91%)	4 / 136 (2.94%)
occurrences all number	0	3	7	2	4	6	5	3	4
Abdominal distension
subjects affected / exposed	3 / 103 (2.91%)	7 / 102 (6.86%)	4 / 103 (3.88%)	2 / 103 (1.94%)	6 / 102 (5.88%)	8 / 102 (7.84%)	6 / 103 (5.83%)	6 / 103 (5.83%)	1 / 136 (0.74%)
occurrences all number	3	8	6	2	7	10	7	7	1
Abdominal pain
subjects affected / exposed	5 / 103 (4.85%)	3 / 102 (2.94%)	16 / 103 (15.53%)	8 / 103 (7.77%)	9 / 102 (8.82%)	8 / 102 (7.84%)	5 / 103 (4.85%)	4 / 103 (3.88%)	3 / 136 (2.21%)
occurrences all number	8	6	18	10	11	8	5	5	4
Abdominal pain upper
subjects affected / exposed	2 / 103 (1.94%)	4 / 102 (3.92%)	6 / 103 (5.83%)	6 / 103 (5.83%)	4 / 102 (3.92%)	6 / 102 (5.88%)	9 / 103 (8.74%)	5 / 103 (4.85%)	2 / 136 (1.47%)
occurrences all number	2	4	6	6	5	7	14	7	2
Constipation
subjects affected / exposed	13 / 103 (12.62%)	22 / 102 (21.57%)	26 / 103 (25.24%)	18 / 103 (17.48%)	24 / 102 (23.53%)	19 / 102 (18.63%)	29 / 103 (28.16%)	24 / 103 (23.30%)	6 / 136 (4.41%)
occurrences all number	15	27	33	25	35	23	34	30	7
Diarrhoea
subjects affected / exposed	20 / 103 (19.42%)	25 / 102 (24.51%)	35 / 103 (33.98%)	27 / 103 (26.21%)	38 / 102 (37.25%)	28 / 102 (27.45%)	28 / 103 (27.18%)	29 / 103 (28.16%)	16 / 136 (11.76%)
occurrences all number	29	37	60	54	62	52	49	46	23
Dyspepsia
subjects affected / exposed	3 / 103 (2.91%)	8 / 102 (7.84%)	6 / 103 (5.83%)	14 / 103 (13.59%)	14 / 102 (13.73%)	15 / 102 (14.71%)	13 / 103 (12.62%)	8 / 103 (7.77%)	4 / 136 (2.94%)
occurrences all number	5	8	8	24	17	16	19	13	5
Eructation
subjects affected / exposed	4 / 103 (3.88%)	8 / 102 (7.84%)	14 / 103 (13.59%)	8 / 103 (7.77%)	7 / 102 (6.86%)	17 / 102 (16.67%)	10 / 103 (9.71%)	6 / 103 (5.83%)	1 / 136 (0.74%)
occurrences all number	4	13	20	12	7	21	12	9	1
Flatulence
subjects affected / exposed	4 / 103 (3.88%)	4 / 102 (3.92%)	3 / 103 (2.91%)	3 / 103 (2.91%)	6 / 102 (5.88%)	8 / 102 (7.84%)	5 / 103 (4.85%)	5 / 103 (4.85%)	3 / 136 (2.21%)
occurrences all number	4	4	4	3	9	10	8	6	3
Gastrooesophageal reflux disease
subjects affected / exposed	8 / 103 (7.77%)	9 / 102 (8.82%)	8 / 103 (7.77%)	7 / 103 (6.80%)	10 / 102 (9.80%)	10 / 102 (9.80%)	9 / 103 (8.74%)	8 / 103 (7.77%)	0 / 136 (0.00%)
occurrences all number	8	9	8	8	11	13	13	9	0
Nausea
subjects affected / exposed	32 / 103 (31.07%)	42 / 102 (41.18%)	45 / 103 (43.69%)	43 / 103 (41.75%)	49 / 102 (48.04%)	55 / 102 (53.92%)	50 / 103 (48.54%)	46 / 103 (44.66%)	24 / 136 (17.65%)
occurrences all number	41	80	74	69	94	106	97	89	30
Vomiting
subjects affected / exposed	8 / 103 (7.77%)	18 / 102 (17.65%)	24 / 103 (23.30%)	11 / 103 (10.68%)	17 / 102 (16.67%)	21 / 102 (20.59%)	23 / 103 (22.33%)	11 / 103 (10.68%)	6 / 136 (4.41%)
occurrences all number	10	29	41	18	34	32	46	17	6
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 103 (4.85%)	5 / 102 (4.90%)	3 / 103 (2.91%)	6 / 103 (5.83%)	2 / 102 (1.96%)	3 / 102 (2.94%)	1 / 103 (0.97%)	3 / 103 (2.91%)	5 / 136 (3.68%)
occurrences all number	5	5	3	6	2	3	1	3	5
Oropharyngeal pain
subjects affected / exposed	2 / 103 (1.94%)	8 / 102 (7.84%)	3 / 103 (2.91%)	1 / 103 (0.97%)	4 / 102 (3.92%)	5 / 102 (4.90%)	4 / 103 (3.88%)	4 / 103 (3.88%)	7 / 136 (5.15%)
occurrences all number	2	9	4	1	4	6	4	5	7
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	1 / 103 (0.97%)	3 / 102 (2.94%)	1 / 103 (0.97%)	6 / 103 (5.83%)	1 / 102 (0.98%)	1 / 102 (0.98%)	6 / 103 (5.83%)	3 / 103 (2.91%)	1 / 136 (0.74%)
occurrences all number	1	3	1	6	1	1	6	3	1
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 103 (0.97%)	0 / 102 (0.00%)	6 / 103 (5.83%)	2 / 103 (1.94%)	1 / 102 (0.98%)	2 / 102 (1.96%)	1 / 103 (0.97%)	3 / 103 (2.91%)	5 / 136 (3.68%)
occurrences all number	1	0	6	3	1	2	1	3	5
Insomnia
subjects affected / exposed	3 / 103 (2.91%)	6 / 102 (5.88%)	2 / 103 (1.94%)	1 / 103 (0.97%)	3 / 102 (2.94%)	2 / 102 (1.96%)	2 / 103 (1.94%)	2 / 103 (1.94%)	1 / 136 (0.74%)
occurrences all number	3	6	2	1	3	2	2	2	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	7 / 103 (6.80%)	9 / 102 (8.82%)	6 / 103 (5.83%)	4 / 103 (3.88%)	7 / 102 (6.86%)	4 / 102 (3.92%)	4 / 103 (3.88%)	5 / 103 (4.85%)	10 / 136 (7.35%)
occurrences all number	9	13	7	4	8	5	6	5	10
Back pain
subjects affected / exposed	8 / 103 (7.77%)	11 / 102 (10.78%)	6 / 103 (5.83%)	9 / 103 (8.74%)	3 / 102 (2.94%)	7 / 102 (6.86%)	8 / 103 (7.77%)	7 / 103 (6.80%)	10 / 136 (7.35%)
occurrences all number	17	16	6	10	3	7	8	7	11
Infections and infestations
Bronchitis
subjects affected / exposed	4 / 103 (3.88%)	5 / 102 (4.90%)	4 / 103 (3.88%)	7 / 103 (6.80%)	3 / 102 (2.94%)	3 / 102 (2.94%)	2 / 103 (1.94%)	1 / 103 (0.97%)	9 / 136 (6.62%)
occurrences all number	6	5	6	7	3	3	2	2	12
Gastroenteritis
subjects affected / exposed	5 / 103 (4.85%)	11 / 102 (10.78%)	6 / 103 (5.83%)	8 / 103 (7.77%)	10 / 102 (9.80%)	4 / 102 (3.92%)	6 / 103 (5.83%)	4 / 103 (3.88%)	4 / 136 (2.94%)
occurrences all number	7	15	6	9	11	4	6	5	6
Influenza
subjects affected / exposed	2 / 103 (1.94%)	10 / 102 (9.80%)	4 / 103 (3.88%)	10 / 103 (9.71%)	2 / 102 (1.96%)	5 / 102 (4.90%)	7 / 103 (6.80%)	8 / 103 (7.77%)	8 / 136 (5.88%)
occurrences all number	2	14	6	13	2	5	7	9	9
Nasopharyngitis
subjects affected / exposed	16 / 103 (15.53%)	23 / 102 (22.55%)	19 / 103 (18.45%)	15 / 103 (14.56%)	19 / 102 (18.63%)	16 / 102 (15.69%)	20 / 103 (19.42%)	16 / 103 (15.53%)	16 / 136 (11.76%)
occurrences all number	20	26	24	20	26	18	27	22	26
Sinusitis
subjects affected / exposed	4 / 103 (3.88%)	5 / 102 (4.90%)	7 / 103 (6.80%)	3 / 103 (2.91%)	6 / 102 (5.88%)	5 / 102 (4.90%)	4 / 103 (3.88%)	6 / 103 (5.83%)	8 / 136 (5.88%)
occurrences all number	6	7	10	3	6	6	6	6	8
Upper respiratory tract infection
subjects affected / exposed	12 / 103 (11.65%)	10 / 102 (9.80%)	13 / 103 (12.62%)	10 / 103 (9.71%)	11 / 102 (10.78%)	10 / 102 (9.80%)	7 / 103 (6.80%)	12 / 103 (11.65%)	13 / 136 (9.56%)
occurrences all number	16	12	17	15	16	11	8	16	19
Urinary tract infection
subjects affected / exposed	3 / 103 (2.91%)	6 / 102 (5.88%)	4 / 103 (3.88%)	6 / 103 (5.83%)	2 / 102 (1.96%)	4 / 102 (3.92%)	3 / 103 (2.91%)	3 / 103 (2.91%)	5 / 136 (3.68%)
occurrences all number	3	6	5	6	2	5	3	3	11
Viral infection
subjects affected / exposed	5 / 103 (4.85%)	6 / 102 (5.88%)	3 / 103 (2.91%)	3 / 103 (2.91%)	4 / 102 (3.92%)	3 / 102 (2.94%)	4 / 103 (3.88%)	4 / 103 (3.88%)	4 / 136 (2.94%)
occurrences all number	5	8	3	3	4	3	5	4	4
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	8 / 103 (7.77%)	17 / 102 (16.67%)	13 / 103 (12.62%)	13 / 103 (12.62%)	14 / 102 (13.73%)	18 / 102 (17.65%)	20 / 103 (19.42%)	12 / 103 (11.65%)	5 / 136 (3.68%)
occurrences all number	8	17	14	14	14	21	23	13	5

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Were there any global substantial amendments to the protocol? Yes

26 Aug 2015

1) Clarifications of adequate contraceptive measures in Canada (one of the exclusion criteria), data collection of history of gallbladder disease, thyroid disease events that must be sent for adjudication and addition of timelines for adjudication. 2) Addition of standardised assessment of injection site reactions was added.

27 Sep 2016

This amendment addressed comments raised by the FDA during the investigational new drug (IND) review and clarified trial procedures: 1) The title and design was changed to a “sixteen armed” trial, as operationally there are 16 arms 2) In addition to the pooled data, supportive statistical analyses of primary endpoint including separate placebo arms were added. Descriptive statistics/plots for both pooled and separate placebo arms were added 3) To evaluate the intention-to-treat (ITT) estimand, the definition of effectiveness (and efficacy) estimand was added 4) The primary imputation approach was kept, and the imputation model was updated. Notes on the number of imputations were added. Sensitivity analyses were replaced with more appropriate approaches including the suggestions from FDA 5) Definitions of “in-trial” and “on-treatment” observation periods were added in the statistical section. It was clarified that safety endpoints were evaluated using the on-treatment observation period and the in-trial observation period. 6) It was clarified that hypoglycaemic episodes were tabulated according to full American Diabetes Association (ADA) classifications of hypoglycaemic episodes 7) Thyroid neoplasms were initially to be adjudicated centrally for the trial, but as the number of thyroid neoplasms was subsequently expected to be low, all trial procedures related to collection and central reading of thyroid pathology slides were removed 8) Retention of site files was changed to 15 years to comply with updated Novo Nordisk Standard Operating Procedure 9) Minor clarifications and correction of inconsistencies.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator

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Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Relative change from baseline in body weight (%)

Primary: Relative change from baseline in body weight (%)

Secondary: Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

Secondary: Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

Secondary: Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

Secondary: Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

Secondary: Change in body weight (kg)

Secondary: Change in body weight (kg)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in fasting plasma glucose (FPG)

Secondary: Change in fasting plasma glucose (FPG)

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Clinical trials

Clinical Trial Results: Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Relative change from baseline in body weight (%)

Primary: Relative change from baseline in body weight (%)

Secondary: Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

Secondary: Proportion (%) of subjects with weight loss of ≥ 5% of baseline body weight

Secondary: Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

Secondary: Proportion (%) of subjects with weight loss of ≥ 10% of baseline body

Secondary: Change in body weight (kg)

Secondary: Change in body weight (kg)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in fasting plasma glucose (FPG)

Secondary: Change in fasting plasma glucose (FPG)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator