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

    Summary
    EudraCT number
    		 2022-000790-94
    Trial protocol
    		 GR   PT   NO   SK   HU   BG  
    Global end of trial date
    26 Nov 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9536-4999
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05646706
    WHO universal trial number (UTN)
    		 U1111-1274-4259
    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
    26 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To demonstrate the superiority of semaglutide subcutaneous (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 relative change and achieving greater than or equal to (>=) 5 percentage (%) reduction in body weight after 72 weeks, in adults with obesity.
    Protection of trial subjects
    This study was conducted in accordance with the International Council for Harmonization (ICH) Good Clinical Practice (GCP), the Declaration of Helsinki, and Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 312.120. Essential documents will be maintained and archived in accordance with ICH GCP.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    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: 118
    Country: Number of subjects enrolled
    Canada: 68
    Country: Number of subjects enrolled
    Germany: 139
    Country: Number of subjects enrolled
    Greece: 173
    Country: Number of subjects enrolled
    Hungary: 93
    Country: Number of subjects enrolled
    Norway: 50
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    Portugal: 34
    Country: Number of subjects enrolled
    Slovakia: 100
    Country: Number of subjects enrolled
    United States: 404
    Country: Number of subjects enrolled
    South Africa: 106
    Worldwide total number of subjects
    1407
    EEA total number of subjects
    829
    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)
    1309
    From 65 to 84 years
    98
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 90 sites in 11 countries as follows: Bulgaria, Canada, Germany, Greece, Hungary, Norway, Poland, Portugal, Slovakia, South Africa, and the Unites States.

    Pre-assignment
    Screening details
    		 The trial included a treatment period of 72 weeks (20 weeks of dose escalation and 52 weeks of maintenance period) followed by 9-week follow-up period. Subjects were randomized in 5:1:1 ratio in either semaglutide 7.2 mg, semaglutide 2.4 mg or placebo as an adjunct to reduced-calorie diet and increased physical activity.

    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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 7.2 mg
    Arm description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
    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 Semaglutide injection once weekly at the same day of the week. Injections were to be administered in the thigh, abdomen or upper arm at any time of day irrespective of meals.

    Arm title
    		 Semaglutide 2.4 mg
    Arm description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
    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 Semaglutide injection once weekly at the same day of the week. Injections were to be administered in the thigh, abdomen or upper arm at any time of day irrespective of meals.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo (matched to Semaglutide) injection once weekly at the same day of the week. Injections were to be administered in the thigh, abdomen or upper arm at any time of day irrespective of meals.

    Number of subjects in period 1
    		Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo
    Started
    1005
    201
    201
    Full analysis set
    1005
    201
    201
    Safety analysis set
    1004
    201
    201
    Completed
    959
    190
    180
    Not completed
    46
    11
    21
         Consent withdrawn by subject
    18
    6
    16
         Physician decision
    4
    -
    -
         Lost to follow-up
    24
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.

    Reporting group values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg Placebo Total
    Number of subjects
    		 1005 201 201 1407
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 12 ) 46 ( 12 ) 48 ( 12 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 753 137 147 1037
        Male
    		 252 64 54 370
    Subject analysis sets

    Subject analysis set title
    Pooled Semaglutide (7.2 mg + 2.4 mg)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. Pooled Semaglutide group was used as sub-population for MRI assessment.

    Subject analysis sets values
    		 Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects
    49
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ( 0 )
    Gender Categorical
    Units: Subjects
        Female
    39
        Male
    10

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.

    Subject analysis set title
    Pooled Semaglutide (7.2 mg + 2.4 mg)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. Pooled Semaglutide group was used as sub-population for MRI assessment.

    Primary: Semaglutide 7.2 mg versus Placebo: Relative change in body weight

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    End point title
    		 Semaglutide 7.2 mg versus Placebo: Relative change in body weight [1]
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: Percentage (%) of body weight
        arithmetic mean (standard deviation)
    -19.5 ( 10.6 )
    -3.8 ( 7.1 )
    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
    Semaglutide 7.2 mg v Placebo
    Number of subjects included in analysis
    1121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -14.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.21
         upper limit
    		 -13.41

    Primary: ≥5% body weight reduction (yes/no)

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    End point title
    		 ≥5% body weight reduction (yes/no) [2]
    End point description
    Number of subjects who achieve body weight reduction >=5% from baseline (week 0) is presented in categories as "yes" or "no" where "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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: Subjects
        Yes
    862
    63
        No
    88
    108
    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
    1121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Binary regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.32
         upper limit
    		 17.61

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

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    End point title
    		 ≥10% body weight reduction (yes/no) [3]
    End point description
    Number of subjects who achieve body weight reduction >=10% from baseline (week 0) is presented in categories as "yes" or "no" where "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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: Subjects
        Yes
    783
    35
        No
    167
    136
    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) [4]
    End point description
    Number of subjects who achieve body weight reduction >=15% from baseline (week 0) is presented in categories as "yes" or "no" where "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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: Subjects
        Yes
    632
    13
        No
    318
    158
    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% from baseline (week 0) is presented in categories as "yes" or "no" where "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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the 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
    950
    189
    171
    Units: Subjects
        Yes
    453
    63
    5
        No
    497
    126
    166
    No statistical analyses for this end point

    Secondary: ≥25% body weight reduction (yes/no)

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    End point title
    		 ≥25% body weight reduction (yes/no)
    End point description
    Number of subjects who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines subjects who achieved body weight reduction >=25% and "no" defines subjects who did not achieve body weight reduction >=25%. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the 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
    950
    189
    171
    Units: Subjects
        Yes
    296
    29
    0
        No
    654
    160
    171
    No statistical analyses for this end point

    Secondary: Change in waist circumference

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    End point title
    		 Change in waist circumference [5]
    End point description
    Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    -18.0 ( 10.5 )
    -5.6 ( 7.4 )
    No statistical analyses for this end point

    Secondary: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight

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    End point title
    		 Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight [6]
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
    End point values
    		 Semaglutide 7.2 mg Semaglutide 2.4 mg
    Number of subjects analysed
    950
    189
    Units: % of body weight
        arithmetic mean (standard deviation)
    -19.5 ( 10.6 )
    -16.4 ( 9.2 )
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the 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
    950
    189
    171
    Units: Kilograms (kg)
        arithmetic mean (standard deviation)
    -21.7 ( 12.3 )
    -18.7 ( 10.4 )
    -4.3 ( 8.0 )
    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) [7]
    End point description
    Change in BMI from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    950
    171
    Units: kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    -7.7 ( 4.4 )
    -1.5 ( 2.9 )
    No statistical analyses for this end point

    Secondary: Change in total fat mass (%)

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    End point title
    		 Change in total fat mass (%) [8]
    End point description
    Change in total fat mass (%) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in Statistical Analysis Plan (SAP) section 4.3.2, the reporting groups semaglutide 7.2 and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2mg + 2.4mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: % of total fat mass
        arithmetic mean (standard deviation)
    -2.7 ( 7.3 )
    -26.9 ( 18.1 )
    No statistical analyses for this end point

    Secondary: Change in total fat mass (liters)

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    End point title
    		 Change in total fat mass (liters) [9]
    End point description
    Change in total fat mass (liters) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: liters
        arithmetic mean (standard deviation)
    -1.5 ( 4.1 )
    -11.7 ( 8.8 )
    No statistical analyses for this end point

    Secondary: Change in lean body mass (%)

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    End point title
    		 Change in lean body mass (%) [10]
    End point description
    Change in lean body mass (%) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: % of lean body mass
        arithmetic mean (standard deviation)
    -0.4 ( 4.2 )
    -7.5 ( 7.4 )
    No statistical analyses for this end point

    Secondary: Change in lean body mass (liters)

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    End point title
    		 Change in lean body mass (liters) [11]
    End point description
    Change in lean body mass (liters) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: liters
        arithmetic mean (standard deviation)
    -0.2 ( 0.9 )
    -1.9 ( 2.0 )
    No statistical analyses for this end point

    Secondary: Change in visceral fat mass (%)

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    End point title
    		 Change in visceral fat mass (%) [12]
    End point description
    Change in visceral fat mass (%) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: % of visceral fat mass
        arithmetic mean (standard deviation)
    -8.8 ( 16.0 )
    -33.6 ( 22.9 )
    No statistical analyses for this end point

    Secondary: Change in visceral fat mass (liters)

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    End point title
    		 Change in visceral fat mass (liters) [13]
    End point description
    Change in visceral fat mass (liters) from baseline (week 0) to end of treatment (week 72) is presented. MRI analysis set included all subjects in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Number of subjects analyzed = Subjects with available data for the endpoint. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the endpoint. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for single pooled semaglutide (7.2 mg + 2.4 mg) and placebo groups.
    End point values
    		 Placebo Pooled Semaglutide (7.2 mg + 2.4 mg)
    Number of subjects analysed
    5
    45
    Units: liters
        arithmetic mean (standard deviation)
    -0.2 ( 0.6 )
    -1.8 ( 1.3 )
    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 [14]
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    949
    171
    Units: millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    -10 ( 14 )
    -4 ( 12 )
    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 [15]
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    949
    171
    Units: mmHg
        arithmetic mean (standard deviation)
    -5 ( 9 )
    -1 ( 9 )
    No statistical analyses for this end point

    Secondary: Change in total cholesterol (milligram per deciliter [mg/dL]) - Ratio to Baseline

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    End point title
    		 Change in total cholesterol (milligram per deciliter [mg/dL]) - Ratio to Baseline [16]
    End point description
    Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    935
    167
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.94 ( 16.7 )
    1.00 ( 16.8 )
    No statistical analyses for this end point

    Secondary: Change in total cholesterol (millimoles per liter [mmol/L]) - Ratio to Baseline

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    End point title
    		 Change in total cholesterol (millimoles per liter [mmol/L]) - Ratio to Baseline [17]
    End point description
    Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    935
    167
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.94 ( 16.7 )
    1.00 ( 16.8 )
    No statistical analyses for this end point

    Secondary: Change in high-density lipoprotein (HDL) cholesterol (mg/dL) - Ratio to Baseline

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    End point title
    		 Change in high-density lipoprotein (HDL) cholesterol (mg/dL) - Ratio to Baseline [18]
    End point description
    Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    921
    165
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.08 ( 15.9 )
    1.02 ( 15.2 )
    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 [19]
    End point description
    Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    921
    165
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.08 ( 15.9 )
    1.02 ( 15.2 )
    No statistical analyses for this end point

    Secondary: Change in low-density lipoprotein (LDL) cholesterol (mg/dL) - Ratio to Baseline

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    End point title
    		 Change in low-density lipoprotein (LDL) cholesterol (mg/dL) - Ratio to Baseline [20]
    End point description
    Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    921
    165
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.92 ( 25.5 )
    0.98 ( 28.6 )
    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 [21]
    End point description
    Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    921
    165
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.92 ( 25.5 )
    0.98 ( 28.6 )
    No statistical analyses for this end point

    Secondary: Change in very low-density lipoprotein (VLDL) cholesterol (mg/dL) - Ratio to Baseline

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    End point title
    		 Change in very low-density lipoprotein (VLDL) cholesterol (mg/dL) - Ratio to Baseline [22]
    End point description
    Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    931
    165
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.76 ( 39.3 )
    1.00 ( 36.8 )
    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 [23]
    End point description
    Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    931
    165
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.76 ( 39.3 )
    1.00 ( 36.8 )
    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 [24]
    End point description
    Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    933
    165
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.76 ( 40.9 )
    0.99 ( 38.1 )
    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 [25]
    End point description
    Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    933
    165
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.76 ( 40.9 )
    0.99 ( 38.1 )
    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 [26]
    End point description
    Change in hsCRP (milligram per liter [mg/L]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    934
    167
    Units: Ratio of hsCRP
        geometric mean (geometric coefficient of variation)
    0.38 ( 128.9 )
    0.89 ( 89.9 )
    No statistical analyses for this end point

    Secondary: Change in lipid-lowering treatment (decrease, no change, increase)

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    End point title
    		 Change in lipid-lowering treatment (decrease, no change, increase) [27]
    End point description
    Number of subjects with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    163
    28
    Units: Subjects
        Decreased
    8
    0
        No change
    138
    22
        Increased
    17
    6
    No statistical analyses for this end point

    Secondary: Change in antihypertensive treatment (decrease, no change, increase)

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    End point title
    		 Change in antihypertensive treatment (decrease, no change, increase) [28]
    End point description
    Number of subjects with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    322
    59
    Units: Subjects
        Decreased
    57
    6
        No change
    233
    47
        Increased
    32
    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) [29]
    End point description
    Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    938
    167
    Units: % of HbA1c
        arithmetic mean (standard deviation)
    -0.3 ( 0.3 )
    0.0 ( 0.3 )
    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 [30]
    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 randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    923
    160
    Units: mg/dL
        arithmetic mean (standard deviation)
    -11.7 ( 11.9 )
    -1.7 ( 11.7 )
    No statistical analyses for this end point

    Secondary: Change in fasting serum insulin (picomoles per liter [pmol/L]) - Ratio to Baseline

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    End point title
    		 Change in fasting serum insulin (picomoles per liter [pmol/L]) - Ratio to Baseline [31]
    End point description
    Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    902
    158
    Units: Ratio of fasting serum insulin
        geometric mean (geometric coefficient of variation)
    0.61 ( 66.6 )
    0.90 ( 62.9 )
    No statistical analyses for this end point

    Secondary: Change in fasting serum insulin (milliinternational units per milliliter [mIU/mL]) - Ratio to Baseline

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    End point title
    		 Change in fasting serum insulin (milliinternational units per milliliter [mIU/mL]) - Ratio to Baseline [32]
    End point description
    Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    902
    158
    Units: Ratio of fasting serum insulin
        geometric mean (geometric coefficient of variation)
    0.61 ( 66.6 )
    0.90 ( 62.9 )
    No statistical analyses for this end point

    Secondary: Change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])

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    End point title
    		 Change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D]) [33]
    End point description
    Number of subjects with change in glycaemic categories from baseline (week 0) presented as Normo-glycaemia, pre-diabetes, type 2 diabetes. Full analysis set included all randomized subjects. Subjects were analysed according to the randomised treatment. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    951
    168
    Units: Subjects
        Normo-glycaemia to Normo-glycaemia
    574
    75
        Normo-glycaemia to Pre-diabetes
    21
    20
        Normo-glycaemia to Diabetes
    0
    2
        Pre-diabetes to Normo-glycaemia
    297
    26
        Pre-diabetes to Pre-diabetes
    59
    42
        Pre-diabetes to Diabetes
    0
    3
    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 subjects 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 trial product. Subjects were analysed according to the treatment they actually received.
    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
    1004
    201
    201
    Units: Events
    6430
    1133
    743
    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. A 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 trial product. Subjects were analysed according to the treatment they actually received.
    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
    1004
    201
    201
    Units: Events
    100
    31
    16
    No statistical analyses for this end point

    Secondary: Change in pulse

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    End point title
    		 Change in pulse [34]
    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 trial product. Subjects were analysed according to the treatment they actually received. Number of subjects analyzed = Subjects with available data for the endpoint. The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 72)
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for semaglutide 7.2 mg and placebo groups.
    End point values
    		 Semaglutide 7.2 mg Placebo
    Number of subjects analysed
    872
    140
    Units: Beats per minute (bpm)
        arithmetic mean (standard deviation)
    1 ( 10 )
    -2 ( 11 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (week 0) to end of study (week 81)
    Adverse event reporting additional description
    Safety analysis set included all subjects who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized subjects in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Semaglutide 7.2 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.

    Serious adverse events
    		 Semaglutide 7.2 mg Placebo Semaglutide 2.4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    73 / 1004 (7.27%)
    11 / 201 (5.47%)
    22 / 201 (10.95%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast angiosarcoma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Breast cancer
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Haemangioma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Intraductal papilloma of breast
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Malignant melanoma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Neuroma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Renal cell carcinoma
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 1004 (0.10%)
    1 / 201 (0.50%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion threatened
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         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
    Capsular contracture associated with breast implant
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Chest pain
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    General physical health deterioration
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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 cyst
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Pleurisy
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         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 embolism
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Respiratory failure
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Psychotic disorder
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Suicidal ideation
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Investigations
    Liver function test increased
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Incisional hernia
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Meniscus injury
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Tendon rupture
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Procedural pain
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Atrial flutter
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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 arrest
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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 chronic
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Coronary artery stenosis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Cranial nerve paralysis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Epilepsy
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Multiple sclerosis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Sciatica
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Syncope
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Blood loss anaemia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Eye disorders
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Retinal detachment
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Abdominal pain lower
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Abdominal hernia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Enteritis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Faecaloma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Gastritis
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Hiatus hernia
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Internal hernia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Pancreatitis acute
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Vomiting
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Hepatobiliary disorders
    Biloma
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Cholecystitis
         subjects affected / exposed
    3 / 1004 (0.30%)
    0 / 201 (0.00%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    4 / 1004 (0.40%)
    0 / 201 (0.00%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    6 / 1004 (0.60%)
    1 / 201 (0.50%)
    2 / 201 (1.00%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Osteoarthritis
         subjects affected / exposed
    2 / 1004 (0.20%)
    1 / 201 (0.50%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Undifferentiated connective tissue disease
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         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
    Abdominal abscess
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Cellulitis
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         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 valve vegetation
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Complicated appendicitis
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Diverticulitis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Erysipelas
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Gastroenteritis viral
         subjects affected / exposed
    0 / 1004 (0.00%)
    1 / 201 (0.50%)
    0 / 201 (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
    Osteomyelitis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Pneumonia
         subjects affected / exposed
    2 / 1004 (0.20%)
    0 / 201 (0.00%)
    0 / 201 (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
    Viral infection
         subjects affected / exposed
    0 / 1004 (0.00%)
    0 / 201 (0.00%)
    1 / 201 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Dehydration
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    Obesity
         subjects affected / exposed
    1 / 1004 (0.10%)
    0 / 201 (0.00%)
    0 / 201 (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
    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
    784 / 1004 (78.09%)
    117 / 201 (58.21%)
    140 / 201 (69.65%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    18 / 1004 (1.79%)
    12 / 201 (5.97%)
    7 / 201 (3.48%)
         occurrences all number
    18
    12
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    63 / 1004 (6.27%)
    3 / 201 (1.49%)
    12 / 201 (5.97%)
         occurrences all number
    82
    4
    14
    Hyperaesthesia
         subjects affected / exposed
    55 / 1004 (5.48%)
    1 / 201 (0.50%)
    1 / 201 (0.50%)
         occurrences all number
    73
    1
    1
    Headache
         subjects affected / exposed
    99 / 1004 (9.86%)
    17 / 201 (8.46%)
    16 / 201 (7.96%)
         occurrences all number
    137
    25
    26
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    112 / 1004 (11.16%)
    7 / 201 (3.48%)
    19 / 201 (9.45%)
         occurrences all number
    153
    10
    21
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    62 / 1004 (6.18%)
    6 / 201 (2.99%)
    12 / 201 (5.97%)
         occurrences all number
    92
    6
    17
    Abdominal pain upper
         subjects affected / exposed
    58 / 1004 (5.78%)
    10 / 201 (4.98%)
    4 / 201 (1.99%)
         occurrences all number
    74
    12
    5
    Constipation
         subjects affected / exposed
    234 / 1004 (23.31%)
    18 / 201 (8.96%)
    39 / 201 (19.40%)
         occurrences all number
    322
    19
    62
    Diarrhoea
         subjects affected / exposed
    274 / 1004 (27.29%)
    26 / 201 (12.94%)
    56 / 201 (27.86%)
         occurrences all number
    507
    39
    91
    Dyspepsia
         subjects affected / exposed
    103 / 1004 (10.26%)
    7 / 201 (3.48%)
    12 / 201 (5.97%)
         occurrences all number
    140
    8
    12
    Eructation
         subjects affected / exposed
    92 / 1004 (9.16%)
    1 / 201 (0.50%)
    16 / 201 (7.96%)
         occurrences all number
    130
    1
    25
    Gastrooesophageal reflux disease
         subjects affected / exposed
    48 / 1004 (4.78%)
    6 / 201 (2.99%)
    13 / 201 (6.47%)
         occurrences all number
    55
    33
    15
    Nausea
         subjects affected / exposed
    439 / 1004 (43.73%)
    27 / 201 (13.43%)
    77 / 201 (38.31%)
         occurrences all number
    907
    40
    148
    Vomiting
         subjects affected / exposed
    249 / 1004 (24.80%)
    14 / 201 (6.97%)
    33 / 201 (16.42%)
         occurrences all number
    524
    23
    65
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    72 / 1004 (7.17%)
    3 / 201 (1.49%)
    8 / 201 (3.98%)
         occurrences all number
    74
    3
    8
    Sensitive skin
         subjects affected / exposed
    71 / 1004 (7.07%)
    0 / 201 (0.00%)
    0 / 201 (0.00%)
         occurrences all number
    101
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    43 / 1004 (4.28%)
    9 / 201 (4.48%)
    14 / 201 (6.97%)
         occurrences all number
    50
    11
    18
    Back pain
         subjects affected / exposed
    51 / 1004 (5.08%)
    4 / 201 (1.99%)
    14 / 201 (6.97%)
         occurrences all number
    57
    5
    15
    Infections and infestations
    COVID-19
         subjects affected / exposed
    114 / 1004 (11.35%)
    24 / 201 (11.94%)
    21 / 201 (10.45%)
         occurrences all number
    122
    25
    22
    Nasopharyngitis
         subjects affected / exposed
    82 / 1004 (8.17%)
    25 / 201 (12.44%)
    15 / 201 (7.46%)
         occurrences all number
    117
    34
    21
    Sinusitis
         subjects affected / exposed
    35 / 1004 (3.49%)
    8 / 201 (3.98%)
    12 / 201 (5.97%)
         occurrences all number
    40
    9
    15
    Upper respiratory tract infection
         subjects affected / exposed
    61 / 1004 (6.08%)
    15 / 201 (7.46%)
    13 / 201 (6.47%)
         occurrences all number
    74
    17
    15
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    74 / 1004 (7.37%)
    9 / 201 (4.48%)
    10 / 201 (4.98%)
         occurrences all number
    97
    13
    17

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2022
    The amendment from version 1.0 of the protocol to version 2.0 was an administrative amendment as version 1.0 of the protocol was an internal version.
    04 Oct 2022
    Key changes are listed below: - Editorial changes e.g. spelling errors, punctuation or updates to more exact wording. Discontinuation criteria line added. Crosses corrected for contraceptive counselling, attend visit fasting, anti semaglutide antibodies and administration of trial product. Two confirmatory secondary endpoints added. Number of participants increased to 400 and ran-domisation changed to 5:1:1. Figure 4-1 updated accordingly. Number of participants in the MRI subpopulation increased to 210. New criteria 8 added. New section added. New footnote added to Table 8-1. Hepatic event text deleted. New appendix added. Plan for immunogenicity analyses changed. Text added. Numbers updated.
    16 Feb 2023
    Key changes are listed below: - Editorial changes e.g. spelling errors, punctuation or updates to more exact wording. Biochemistry and haematology assessments added at V16. 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 is allowed. Calcitonin ≥ 100 ng/L added as a discontinuation criterion. Patient Health Questionaire-9 (PHQ-9) and Columbia-Suicide Severity Rating Scale (C-SSRS) at V8, V10, V14 and V18 added to text. Removed from V12 from text. Added ‘Acute kidney injury’. Added direct bilirubin, amylase, calcitonin and lipase. Criteria for hepatic laboratory outliers added. Added ‘Acute kidney injury’. Appendix added. Slovakia requirements added.
    10 Aug 2023
    Key changes are listed below: - Editorial changes e.g. spelling errors, punctuation or updates to more exact wording. Tobacco use assessment added at end-of-treatment (V22) as new endpoint. Removal of the potential risk of 'Neoplasms’ (malignant and non-malignant) from Table 2-1. The number of randomised participants in the MRI subgroup changed from approximately 210 to 50 participants. Update of the dosage and administration of, and transition to, the new drug-device combination product during the maintenance phase. Adding text in Section 8.1.5 clarifying that data collected for the clinical assessments ‘Control of Eating Questionnaire (COEQ)’ and ‘Three Factor eating questionnaire 18-items (TFEQ-R18V2)’ at end-of-study (V23) is explorative and will not be included in the clinical study report.

    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.
    Secondary endpoint “Change in free fatty acids” was removed from secondary endpoints due to lack of baseline data.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40961952
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