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    Clinical Trial Results:
    Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity and type 2 diabetes

    Summary
    EudraCT number
    		 2022-002235-60
    Trial protocol
    		 PT   SK   HU   BG  
    Global end of trial date
    13 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2025
    First version publication date
    24 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9536-7545
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05649137
    WHO universal trial number (UTN)
    		 U1111-1279-0359
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to demonstrate the superiority of semaglutide s.c. 7.2 mg once weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to relative change in body weight after 72 weeks, in adults with obesity and T2D and to demonstrate the superiority of semaglutide subcutaneously (s.c.) 7.2 milligrams (mg) once weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to achieving body weight reduction greater than or equal to (>=) 5 percentage (%) after 72 weeks, in adults with obesity and type 2 diabetes (T2D).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, including archiving of essential documents (May 1996) and EN ISO 14155 Part 1 and 2 and Food and Drugs Administration (FDA) 21 Code of Federal Regulations (CFR) 312.120.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 80
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    Hungary: 76
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Portugal: 10
    Country: Number of subjects enrolled
    Slovakia: 61
    Country: Number of subjects enrolled
    United States: 125
    Country: Number of subjects enrolled
    South Africa: 54
    Worldwide total number of subjects
    512
    EEA total number of subjects
    301
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    391
    From 65 to 84 years
    121
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted across 68 sites in 8 countries.

    Pre-assignment
    Screening details
    		 A total of 512 subjects were randomised in the study out of which 491 subjects completed the study. The study consisted of a 20-week dose escalation period followed by a 52-week maintenance period and a 9-week follow-up period.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 7.2 mg
    Arm description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly 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
    Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.The subcutaneous injection was administered in the thigh, abdomen, or upper arm.

    Arm title
    		 Semaglutide 2.4 mg
    Arm description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly 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
    Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks. The subcutaneous injection was administered in the thigh, abdomen, or upper arm.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo to semaglutide s.c. once a week for 72 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matched to semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo to semaglutide s.c. once a week for 72 weeks. The subcutaneous injection was administered in the thigh, abdomen, or upper arm.

    Number of subjects in period 1
    		Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Started
    307
    103
    102
    Full analysis set (FAS)
    307
    103
    102
    Safety analysis set (SAS)
    307
    103
    102
    Completed
    295
    100
    96
    Not completed
    12
    3
    6
         Physician decision
    1
    1
    -
         Consent withdrawn by subject
    5
    -
    3
         Death
    4
    1
    1
         Unspecified reason
    -
    1
    -
         Lost to follow-up
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to semaglutide s.c. once a week for 72 weeks.

    Reporting group values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo Total
    Number of subjects
    		 307 103 102 512
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 237 73 81 391
        From 65-84 years
    		 70 30 21 121
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ( 10 ) 58 ( 10 ) 55 ( 10 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 166 47 52 265
        Male
    		 141 56 50 247

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to semaglutide s.c. once a week for 72 weeks.

    Primary: Relative change in body weight

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    End point title
    		 Relative change in body weight
    End point description
    Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Percentage (%) of body weight
        arithmetic mean (standard deviation)
    -13.5 ( 8.7 )
    -10.7 ( 8.1 )
    -4.0 ( 6.2 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 72 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate.
    Comparison groups
    Placebo v Semaglutide 7.2 mg
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -9.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.95
         upper limit
    		 -7.71

    Primary: Greater than or equal to (>=) 5% body weight reduction (yes/no)

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    End point title
    		 Greater than or equal to (>=) 5% body weight reduction (yes/no)
    End point description
    Number of subjects with >= 5% body weight reduction (yes/no) is presented. Yes defines subjects who achieved body weight reduction >= 5% and no defines subjects who did not achieve body weight reduction >= 5%. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Subjects
        Yes
    251
    73
    33
        No
    40
    24
    62
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 72 responses were analysed using a binary regression model with randomized treatment as factor and baseline value as covariate.
    Comparison groups
    Semaglutide 7.2 mg v Placebo
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Binary regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.96
         upper limit
    		 16.87

    Secondary: >= 10% body weight reduction (yes/no)

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    End point title
    		 >= 10% body weight reduction (yes/no)
    End point description
    Number of subjects who achieve body weight reduction >=10% is presented. Yes defines subjects who achieved body weight reduction >= 10% and no defines subjects who did not achieve body weight reduction >= 10%. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Subjects
        Yes
    183
    50
    11
        No
    108
    47
    84
    No statistical analyses for this end point

    Secondary: >= 15% body weight reduction (yes/no)

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    End point title
    		 >= 15% body weight reduction (yes/no)
    End point description
    Number of subjects who achieve body weight reduction >=15% is presented. Yes defines subjects who achieved body weight reduction >= 15% and no defines subjects who did not achieve body weight reduction >= 15%. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Subjects
        Yes
    120
    28
    7
        No
    171
    69
    88
    No statistical analyses for this end point

    Secondary: >=20% body weight reduction (yes/no)

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    End point title
    		 >=20% body weight reduction (yes/no)
    End point description
    Number of subjects who achieve body weight reduction >=20% is presented. Yes defines subjects who achieved body weight reduction >= 20% and no defines subjects who did not achieve body weight reduction >= 20%. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Subjects
        Yes
    62
    14
    2
        No
    229
    83
    93
    No statistical analyses for this end point

    Secondary: Change in waist circumference

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    End point title
    		 Change in waist circumference
    End point description
    Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Centimetres (cm)
        arithmetic mean (standard deviation)
    -12.6 ( 10.5 )
    -10.6 ( 8.4 )
    -6.5 ( 10.6 )
    No statistical analyses for this end point

    Secondary: Change in glycated haemoglobin (HbA1c)

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    End point title
    		 Change in glycated haemoglobin (HbA1c)
    End point description
    Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    288
    96
    94
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    -1.8 ( 1.2 )
    -1.7 ( 1.0 )
    -0.3 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    Change in body weight from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    -14.9 ( 10.6 )
    -11.4 ( 8.9 )
    -4.6 ( 7.1 )
    No statistical analyses for this end point

    Secondary: Change in body mass index (BMI)

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    End point title
    		 Change in body mass index (BMI)
    End point description
    Change in BMI from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: kilograms per metre square (kg/m^2)
        arithmetic mean (standard deviation)
    -5.3 ( 3.8 )
    -4.1 ( 3.3 )
    -1.6 ( 2.5 )
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure

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    End point title
    		 Change in systolic blood pressure
    End point description
    Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: Millimetres of mercury (mmHg)
        arithmetic mean (standard deviation)
    -8 ( 13 )
    -7 ( 15 )
    -3 ( 13 )
    No statistical analyses for this end point

    Secondary: Change in diastolic blood pressure

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    End point title
    		 Change in diastolic blood pressure
    End point description
    Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    291
    97
    95
    Units: mmHg
        arithmetic mean (standard deviation)
    -3 ( 9 )
    -3 ( 10 )
    -3 ( 9 )
    No statistical analyses for this end point

    Secondary: Change in total cholesterol (millimoles per litre [mmol/L]) - ratio to baseline

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    End point title
    		 Change in total cholesterol (millimoles per litre [mmol/L]) - ratio to baseline
    End point description
    Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    94
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.96 ( 23.0 )
    0.96 ( 21.1 )
    0.97 ( 28.3 )
    No statistical analyses for this end point

    Secondary: Change in total cholesterol (milligrams per decilitre [mg/dL]) - ratio to baseline

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    End point title
    		 Change in total cholesterol (milligrams per decilitre [mg/dL]) - ratio to baseline
    End point description
    Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    94
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.96 ( 23.0 )
    0.96 ( 21.1 )
    0.97 ( 28.3 )
    No statistical analyses for this end point

    Secondary: Change in high-density lipoprotein (HDL) cholesterol (mmol/L) - ratio to baseline

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    End point title
    		 Change in high-density lipoprotein (HDL) cholesterol (mmol/L) - ratio to baseline
    End point description
    Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    285
    92
    91
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.10 ( 17.8 )
    1.06 ( 13.5 )
    1.07 ( 16.1 )
    No statistical analyses for this end point

    Secondary: Change in HDL cholesterol (mg/dL) - ratio to baseline

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    End point title
    		 Change in HDL cholesterol (mg/dL) - ratio to baseline
    End point description
    Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    285
    92
    91
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.10 ( 17.8 )
    1.06 ( 13.5 )
    1.07 ( 16.1 )
    No statistical analyses for this end point

    Secondary: Change in low-density lipoprotein (LDL) cholesterol (mmol/L) - ratio to baseline

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    End point title
    		 Change in low-density lipoprotein (LDL) cholesterol (mmol/L) - ratio to baseline
    End point description
    Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    285
    92
    92
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.99 ( 40.1 )
    0.95 ( 36.5 )
    0.97 ( 41.4 )
    No statistical analyses for this end point

    Secondary: Change in LDL cholesterol (mg/dL) - ratio to baseline

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    End point title
    		 Change in LDL cholesterol (mg/dL) - ratio to baseline
    End point description
    Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    285
    92
    92
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.99 ( 40.1 )
    0.95 ( 36.5 )
    0.97 ( 41.4 )
    No statistical analyses for this end point

    Secondary: Change in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) - ratio to baseline

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    End point title
    		 Change in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) - ratio to baseline
    End point description
    Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    93
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.72 ( 42.5 )
    0.81 ( 40.4 )
    0.90 ( 47.8 )
    No statistical analyses for this end point

    Secondary: Change in VLDL cholesterol (mg/dL) - ratio to baseline

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    End point title
    		 Change in VLDL cholesterol (mg/dL) - ratio to baseline
    End point description
    Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    93
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.72 ( 42.5 )
    0.81 ( 40.4 )
    0.90 ( 47.8 )
    No statistical analyses for this end point

    Secondary: Change in triglycerides (mmol/L) - ratio to baseline

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    End point title
    		 Change in triglycerides (mmol/L) - ratio to baseline
    End point description
    Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    94
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.71 ( 46.2 )
    0.80 ( 42.2 )
    0.87 ( 54.4 )
    No statistical analyses for this end point

    Secondary: Change in triglycerides (mg/dL) - ratio to baseline

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    End point title
    		 Change in triglycerides (mg/dL) - ratio to baseline
    End point description
    Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    94
    94
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.71 ( 46.2 )
    0.80 ( 42.2 )
    0.87 ( 54.4 )
    No statistical analyses for this end point

    Secondary: Change in free fatty acids (mmol/L) - ratio to baseline

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    End point title
    		 Change in free fatty acids (mmol/L) - ratio to baseline
    End point description
    Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    284
    93
    92
    Units: Ratio of free fatty acids
        geometric mean (geometric coefficient of variation)
    0.74 ( 69.8 )
    0.81 ( 70.6 )
    0.98 ( 65.8 )
    No statistical analyses for this end point

    Secondary: Change in free fatty acids (mg/dL) - ratio to baseline

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    End point title
    		 Change in free fatty acids (mg/dL) - ratio to baseline
    End point description
    Change in free fatty acids in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    284
    93
    92
    Units: Ratio of free fatty acids
        geometric mean (geometric coefficient of variation)
    0.74 ( 69.8 )
    0.81 ( 70.6 )
    0.98 ( 65.8 )
    No statistical analyses for this end point

    Secondary: Change in high-sensitivity c-reactive protein (hsCRP) - ratio to baseline

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    End point title
    		 Change in high-sensitivity c-reactive protein (hsCRP) - ratio to baseline
    End point description
    Change in hsCRP in mg/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    286
    95
    95
    Units: Ratio of hsCRP
        geometric mean (geometric coefficient of variation)
    0.47 ( 166.7 )
    0.48 ( 121.1 )
    0.82 ( 96.0 )
    No statistical analyses for this end point

    Secondary: Change in fasting plasma glucose

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    End point title
    		 Change in fasting plasma glucose
    End point description
    Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    281
    93
    93
    Units: mg/dL
        arithmetic mean (standard deviation)
    -59.6 ( 53.1 )
    -58.4 ( 46.3 )
    -20.2 ( 68.7 )
    No statistical analyses for this end point

    Secondary: Change in fasting serum insulin (picomoles per litre [pmol/L]) - ratio to baseline

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    End point title
    		 Change in fasting serum insulin (picomoles per litre [pmol/L]) - ratio to baseline
    End point description
    Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    281
    92
    91
    Units: Ratio of fasting serum insulin
        geometric mean (geometric coefficient of variation)
    0.77 ( 66.5 )
    0.90 ( 70.6 )
    0.87 ( 71.4 )
    No statistical analyses for this end point

    Secondary: Change in fasting serum insulin (milliinternational units per millilitre [mIU/mL]) - ratio to baseline

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    End point title
    		 Change in fasting serum insulin (milliinternational units per millilitre [mIU/mL]) - ratio to baseline
    End point description
    Change in fasting serum insulin in mIU/mL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    281
    92
    91
    Units: Ratio of fasting serum insulin
        geometric mean (geometric coefficient of variation)
    0.77 ( 66.5 )
    0.90 ( 70.6 )
    0.87 ( 71.4 )
    No statistical analyses for this end point

    Secondary: HbA1c < 7.0 % (53 millimoles per mole [mmol/mol])

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    End point title
    		 HbA1c < 7.0 % (53 millimoles per mole [mmol/mol])
    End point description
    Number of subjects with HbA1c less than (<) 7.0% (53 mmol/mol) from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    288
    96
    94
    Units: Subjects
    235
    75
    27
    No statistical analyses for this end point

    Secondary: HbA1c <= 6.5 % (48 mmol/mol)

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    End point title
    		 HbA1c <= 6.5 % (48 mmol/mol)
    End point description
    Number of subjects with HbA1c less than or equal to (<=) 6.5% (48 mmol/mol) from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomised subjects. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    288
    96
    94
    Units: Subjects
    209
    64
    15
    No statistical analyses for this end point

    Secondary: Number of Adverse Events (AEs)

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    End point title
    		 Number of Adverse Events (AEs)
    End point description
    Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study subject that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. Safety analysis set included all subjects who were exposed to at least one dose of randomised IMP.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of study (week 81)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    307
    103
    102
    Units: Events
    1581
    508
    253
    No statistical analyses for this end point

    Secondary: Number of Serious Adverse Events (SAEs)

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    End point title
    		 Number of Serious Adverse Events (SAEs)
    End point description
    Number of SAEs is reported. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event. Safety analysis set included all subjects who were exposed to at least one dose of randomised IMP.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of study (week 81)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    307
    103
    102
    Units: Events
    39
    35
    21
    No statistical analyses for this end point

    Secondary: Change in pulse

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    End point title
    		 Change in pulse
    End point description
    Change in pulse from baseline (week 0) to end of treatment (week 72) is presented. Safety analysis set included all subjects who were exposed to at least one dose of randomised IMP. Number of subjects analysed signifies subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    271
    92
    84
    Units: Beats per minute (bpm)
        arithmetic mean (standard deviation)
    1 ( 10 )
    2 ( 10 )
    -4 ( 9 )
    No statistical analyses for this end point

    Secondary: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

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    End point title
    		 Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
    End point description
    Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 0) to end of study (week 81) is presented. Safety analysis set included all subjects who were exposed to at least one dose of randomised IMP.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of study (week 81)
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    307
    103
    102
    Units: Episodes
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From week 0 to week 81
    Adverse event reporting additional description
    Safety analysis set included all participants who were exposed to at least one dose of randomised IMP. All presented AEs are treatment emergent AEs (TEAEs). A TEAE is defined as an adverse event which occured during the in-trial period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide subcutaneously (s.c.) (0.25, 0.5, 1.0, 1.7, and 2.4 milligrams [mg]) once weekly for 20 weeks followed by a maintenance dose of semaglutide 7.2 mg s.c. once weekly for 52 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to semaglutide s.c. once a week for 72 weeks

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received escalated dose of semaglutide s.c. (0.25, 0.5, 1.0, 1.7, and 2.4 mg) once weekly for 20 weeks followed by a maintenance dose of semaglutide 2.4 mg s.c. once weekly for 52 weeks.

    Serious adverse events
    		 Semaglutide 7.2 mg Placebo Semaglutide 2.4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 307 (9.77%)
    10 / 102 (9.80%)
    11 / 103 (10.68%)
         number of deaths (all causes)
    4
    1
    1
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 307 (0.33%)
    1 / 102 (0.98%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer stage III
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Intervertebral disc injury
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    2 / 307 (0.65%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 307 (0.65%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 307 (0.33%)
    3 / 102 (2.94%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 307 (0.65%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 307 (0.00%)
    1 / 102 (0.98%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gangrene
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 307 (0.33%)
    0 / 102 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperphosphataemia
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperammonaemia
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 307 (0.00%)
    0 / 102 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 7.2 mg Placebo Semaglutide 2.4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    187 / 307 (60.91%)
    40 / 102 (39.22%)
    64 / 103 (62.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 307 (7.17%)
    4 / 102 (3.92%)
    8 / 103 (7.77%)
         occurrences all number
    42
    4
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    21 / 307 (6.84%)
    5 / 102 (4.90%)
    2 / 103 (1.94%)
         occurrences all number
    34
    5
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    9 / 307 (2.93%)
    4 / 102 (3.92%)
    6 / 103 (5.83%)
         occurrences all number
    9
    6
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    16 / 307 (5.21%)
    3 / 102 (2.94%)
    3 / 103 (2.91%)
         occurrences all number
    19
    3
    4
    Diarrhoea
         subjects affected / exposed
    56 / 307 (18.24%)
    9 / 102 (8.82%)
    21 / 103 (20.39%)
         occurrences all number
    98
    13
    35
    Constipation
         subjects affected / exposed
    45 / 307 (14.66%)
    5 / 102 (4.90%)
    19 / 103 (18.45%)
         occurrences all number
    55
    5
    21
    Dyspepsia
         subjects affected / exposed
    25 / 307 (8.14%)
    2 / 102 (1.96%)
    4 / 103 (3.88%)
         occurrences all number
    36
    2
    4
    Eructation
         subjects affected / exposed
    11 / 307 (3.58%)
    1 / 102 (0.98%)
    8 / 103 (7.77%)
         occurrences all number
    13
    1
    9
    Nausea
         subjects affected / exposed
    89 / 307 (28.99%)
    12 / 102 (11.76%)
    29 / 103 (28.16%)
         occurrences all number
    206
    18
    57
    Vomiting
         subjects affected / exposed
    51 / 307 (16.61%)
    3 / 102 (2.94%)
    14 / 103 (13.59%)
         occurrences all number
    78
    4
    39
    Skin and subcutaneous tissue disorders
    Sensitive skin
         subjects affected / exposed
    18 / 307 (5.86%)
    0 / 102 (0.00%)
    2 / 103 (1.94%)
         occurrences all number
    24
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    17 / 307 (5.54%)
    3 / 102 (2.94%)
    7 / 103 (6.80%)
         occurrences all number
    18
    3
    8
    Arthralgia
         subjects affected / exposed
    16 / 307 (5.21%)
    4 / 102 (3.92%)
    4 / 103 (3.88%)
         occurrences all number
    21
    4
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    22 / 307 (7.17%)
    7 / 102 (6.86%)
    5 / 103 (4.85%)
         occurrences all number
    22
    7
    6
    Nasopharyngitis
         subjects affected / exposed
    9 / 307 (2.93%)
    8 / 102 (7.84%)
    3 / 103 (2.91%)
         occurrences all number
    10
    9
    3
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 307 (5.54%)
    5 / 102 (4.90%)
    9 / 103 (8.74%)
         occurrences all number
    21
    5
    9
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 307 (6.84%)
    5 / 102 (4.90%)
    8 / 103 (7.77%)
         occurrences all number
    25
    6
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2022
    Key changes are listed below: - Editorial changes example spelling errors, punctuation or updates to more exact wording in order to improve readability. Wording related to a T2D indication had been removed including less strict requirements for T2D treatment - Discontinuation criteria line added. - Crosses corrected for contraceptive counselling, pharmacokinetic (PK) sampling, anti semaglutide antibodies, Columbia-Suicide Severity Rating Scale (C-SSRS) since last visit and administration of trial product. - Crosses corrected for contraceptive counselling, PK sampling, anti semaglutide antibodies, C-SSRS since last visit and administration of trial product. - Change in HbA1c changed to confirmatory secondary endpoint and estimands were updated accordingly. - Number of subjects increased to 500 and randomisation changed to 3:1:1. - Hepatic event text deleted. - Plan for Immunogenicity analyses changed. - HbA1c changed from primary to secondary endpoint. - Requirements updated for Canada, Germany, United States, South Africa.
    07 Mar 2023
    The key changes are listed below: - Editorial changes e.g. spelling errors, punctuation or updates to more exact wording to improve readability. - Biochemistry and haematology assessments added at visit (V)16. - Patient Health Questionnaire-9 (PHQ-9) and C-SSRS added to V8, V10, V14 and V18. Removed from V12. - Handout of PK diaries at V22 removed from flowchart. - Added that delaying dose escalation was allowed. - Calcitonin >= 100 nanograms per litre (ng/L) added as a discontinuation criterion. - Added direct bilirubin, amylase, calcitonin and lipase. - Criteria for hepatic laboratory outliers added. - Slovakia requirements added.
    21 Aug 2023
    The key changes are listed below: - Editorial changes e.g. spelling errors, punctuation or updates to more exact wording to improve readability. - Tobacco use assessment added at end-of treatment (V22) as new endpoint. - Removal of the potential risk of 'Neoplasms’ (malignant and nonmalignant). - Update of the dosage and administration of, and transition to, the new drug-device combination product during the maintenance phase.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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