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    Clinical Trial Results:
    Efficacy and safety of oral semaglutide 50 mg once daily in subjects with overweight or obesity

    Summary
    EudraCT number
    		 2020-002953-11
    Trial protocol
    		 FI   FR   DK  
    Global end of trial date
    12 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2024
    First version publication date
    23 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9932-4737
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1253-1670
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, 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
    17 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm superior efficacy on body weight reduction of oral semaglutide 50 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation (ICH) Good Clinical Practice, including archiving of essential documents, and 21 Code of Federal Regulations (CFR) 312.120.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2021
    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
    Canada: 40
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Denmark: 26
    Country: Number of subjects enrolled
    Finland: 67
    Country: Number of subjects enrolled
    France: 51
    Country: Number of subjects enrolled
    Japan: 60
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Russian Federation: 80
    Country: Number of subjects enrolled
    United States: 228
    Worldwide total number of subjects
    667
    EEA total number of subjects
    259
    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)
    587
    From 65 to 84 years
    80
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 50 sites in 9 countries as follows: Canada (5 sites), Denmark (3 sites), Finland (3 sites), France (5 sites), Germany (7 sites), Japan (3 sites), Poland (5 sites), Russia (8 sites) and United States (11 sites).

    Pre-assignment
    Screening details
    		 The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Subjects were randomized in 1:1 ratio either to receive oral semaglutide 50 mg or placebo. The treatment is 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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oral semaglutide 50 mg
    Arm description
    		 Subjects received oral dose of semaglutide tablet once daily for 68 weeks. Subjects initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral semaglutide 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once-daily tablet of oral semaglutide was administered for 4 weeks with escalating doses (3 mg, 7 mg, 14 mg, and 25 mg), followed by a maintenance period of 52 weeks with a dose of 50 mg.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once-daily tablet of oral semaglutide placebo was administered for 4 weeks with escalating doses (3 mg, 7 mg, 14 mg, and 25 mg), followed by a maintenance period of 52 weeks with a dose of 50 mg.

    Number of subjects in period 1
    		Oral semaglutide 50 mg Placebo
    Started
    334
    333
    Completed
    320
    307
    Not completed
    14
    26
         Consent withdrawn by subject
    10
    11
         Physician decision
    -
    1
         Lost to follow-up
    4
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects received oral dose of semaglutide tablet once daily for 68 weeks. Subjects initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.

    Reporting group values
    		 Oral semaglutide 50 mg Placebo Total
    Number of subjects
    		 334 333 667
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 294 293 587
        From 65-84 years
    		 40 40 80
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49 ( 13 ) 50 ( 12 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 247 238 485
        Male
    		 87 95 182

    End points

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    End points reporting groups
    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects received oral dose of semaglutide tablet once daily for 68 weeks. Subjects initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.

    Primary: Relative change in body weight

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    End point title
    		 Relative change in body weight
    End point description
    Relative change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. The on-treatment period was from the date of first trial product administration to the date of last trial product administration excluding potential off-treatment time intervals of more than 3 consecutive days. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint. Number analyzed (n)= number of subjects evaluable for defined row.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Percentage (%) of body weight
    arithmetic mean (standard deviation)
        In-trial (n= 317, 295)
    -15.8 ( 10.3 )
    -2.2 ( 7.2 )
        On-treatment (n= 277, 245)
    -17.0 ( 9.8 )
    -2.0 ( 7.3 )
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.
    Comparison groups
    Oral semaglutide 50 mg v Placebo
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -15.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.07
         upper limit
    		 -14.18
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.
    Comparison groups
    Oral semaglutide 50 mg v Placebo
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -12.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.15
         upper limit
    		 -11.33

    Primary: Achievement of body weight reduction greater than or equal to 5% (Yes/No)

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    End point title
    		 Achievement of body weight reduction greater than or equal to 5% (Yes/No)
    End point description
    Number of subjects who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. The on-treatment period was from the date of first trial product administration to the date of last trial product administration excluding potential off-treatment time intervals of more than 3 consecutive days. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint. Number analyzed (n)= number of subjects evaluable for defined row.
    End point type
    Primary
    End point timeframe
    At end-of-treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Subjects
        In-trial: Yes (n= 317, 295)
    269
    76
        In-trial: No (n= 317, 295)
    48
    219
        On-treatment: Yes (n= 277, 245)
    247
    60
        On-treatment: No (n= 277, 245)
    30
    185
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Week 68 responses were analysed using a binary logistic regression model with randomised treatment as factor and baseline body weight as covariate.
    Comparison groups
    Oral semaglutide 50 mg v Placebo
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    55.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.98
         upper limit
    		 92.41
    Notes
    [1] - Hypothetical estimand
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 68 responses were analysed using a binary logistic regression model with randomised treatment as factor and baseline body weight as covariate.
    Comparison groups
    Oral semaglutide 50 mg v Placebo
    Number of subjects included in analysis
    612
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    12.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.5
         upper limit
    		 18.74
    Notes
    [2] - Treatment policy estimand

    Secondary: Achievement of body weight reduction greater than or equal to 15% (Yes/No)

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    End point title
    		 Achievement of body weight reduction greater than or equal to 15% (Yes/No)
    End point description
    Number of subjects who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    At end-of-treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Subjects
        Yes
    170
    17
        No
    147
    278
    No statistical analyses for this end point

    Secondary: Achievement of body weight reduction greater than or equal to 10% (Yes/No)

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    End point title
    		 Achievement of body weight reduction greater than or equal to 10% (Yes/No)
    End point description
    Number of subjects who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    At end-of-treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Subjects
        Yes
    220
    35
        No
    97
    260
    No statistical analyses for this end point

    Secondary: Change in waist circumference

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    End point title
    		 Change in waist circumference
    End point description
    Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    -13.4 ( 10.0 )
    -2.8 ( 7.3 )
    No statistical analyses for this end point

    Secondary: Achievement of body weight reduction greater than or equal to 20% (Yes/No)

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    End point title
    		 Achievement of body weight reduction greater than or equal to 20% (Yes/No)
    End point description
    Number of subjects who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    At end-of-treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Subjects
        Yes
    107
    8
        No
    210
    287
    No statistical analyses for this end point

    Secondary: Change in body mass index (BMI)

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    End point title
    		 Change in body mass index (BMI)
    End point description
    Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Kilogram per meter square (kg/m^2)
        arithmetic mean (standard deviation)
    -5.9 ( 4.0 )
    -0.9 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) physical function

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    End point title
    		 Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) physical function
    End point description
    The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    298
    278
    Units: Score on a scale
        arithmetic mean (standard deviation)
    14.5 ( 20.2 )
    5.0 ( 19.9 )
    No statistical analyses for this end point

    Secondary: Change in Short Form-36 (SF-36) Physical Function

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    End point title
    		 Change in Short Form-36 (SF-36) Physical Function
    End point description
    The short form 36 (SF-36) form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end-of-treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    303
    280
    Units: Score on a scale
        arithmetic mean (standard deviation)
    2.4 ( 5.7 )
    -0.0 ( 5.4 )
    No statistical analyses for this end point

    Secondary: Change in fasting serum insulin

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    End point title
    		 Change in fasting serum insulin
    End point description
    Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    275
    260
    Units: Ratio of fasting serum insulin
        geometric mean (geometric coefficient of variation)
    0.67 ( 71.4 )
    0.94 ( 55.3 )
    No statistical analyses for this end point

    Secondary: Change in fasting plasma glucose (FPG)

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    End point title
    		 Change in fasting plasma glucose (FPG)
    End point description
    Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    313
    292
    Units: Milligrams per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    -10.3 ( 12.7 )
    -1.8 ( 10.4 )
    No statistical analyses for this end point

    Secondary: Change in glycosylated haemoglobin (HbA1c)

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    End point title
    		 Change in glycosylated haemoglobin (HbA1c)
    End point description
    Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    311
    286
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    -0.2 ( 0.3 )
    0.1 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Change in diastolic blood pressure

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    End point title
    		 Change in diastolic blood pressure
    End point description
    Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Millimeter of mercury (mmHg)
        arithmetic mean (standard deviation)
    -2 ( 9 )
    -1 ( 10 )
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure

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    End point title
    		 Change in systolic blood pressure
    End point description
    Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    317
    295
    Units: Millimeter of mercury (mmHg)
        arithmetic mean (standard deviation)
    -7 ( 14 )
    -1 ( 14 )
    No statistical analyses for this end point

    Secondary: Change in free fatty acids

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    End point title
    		 Change in free fatty acids
    End point description
    Change in free fatty acids (measured in Milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    275
    260
    Units: Ratio of free fatty acids
        geometric mean (geometric coefficient of variation)
    0.87 ( 71.7 )
    1.00 ( 80.2 )
    No statistical analyses for this end point

    Secondary: Change in triglycerides

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    End point title
    		 Change in triglycerides
    End point description
    Change in triglycerides from (measured in milligrams per deciliter (mg/dL)) baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    312
    288
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.77 ( 38.4 )
    0.96 ( 37.5 )
    No statistical analyses for this end point

    Secondary: Change in very low density lipoprotein (VLDL) cholesterol

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    End point title
    		 Change in very low density lipoprotein (VLDL) cholesterol
    End point description
    Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    312
    288
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.77 ( 38.3 )
    0.96 ( 37.2 )
    No statistical analyses for this end point

    Secondary: Change in low density lipoprotein (LDL) cholesterol

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    End point title
    		 Change in low density lipoprotein (LDL) cholesterol
    End point description
    Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    311
    286
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.98 ( 25.8 )
    1.03 ( 26.7 )
    No statistical analyses for this end point

    Secondary: Change in high density lipoprotein (HDL) cholesterol

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    End point title
    		 Change in high density lipoprotein (HDL) cholesterol
    End point description
    Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    311
    286
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.05 ( 16.6 )
    1.01 ( 15.9 )
    No statistical analyses for this end point

    Secondary: Change in total cholesterol

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    End point title
    		 Change in total cholesterol
    End point description
    Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    313
    288
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.97 ( 17.1 )
    1.01 ( 16.6 )
    No statistical analyses for this end point

    Secondary: Number of treatment emergent adverse events

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    End point title
    		 Number of treatment emergent adverse events
    End point description
    Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which subjects was considered exposed to trial product. The endpoint was evaluated based on the data from on-treatment period. The on-treatment period was from the date of first trial product administration to the date of last trial product administration excluding potential off-treatment time intervals. A time point is considered on-treatment if any dose was administered within the prior 49 days.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end-of-study (week 75)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    334
    333
    Units: Events
        number (not applicable)
    2500
    1577
    No statistical analyses for this end point

    Secondary: Number of serious adverse events

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    End point title
    		 Number of serious adverse events
    End point description
    Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event. The endpoint was evaluated based on the data from on-treatment period. The on-treatment period was from the date of first trial product administration to the date of last trial product administration excluding potential off-treatment time intervals. A time point is considered on-treatment if any dose was administered within the prior 49 days.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end-of-study (week 75)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    334
    333
    Units: Events
        number (not applicable)
    44
    48
    No statistical analyses for this end point

    Secondary: Change in high sensitivity C-reactive protein (hsCRP)

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    End point title
    		 Change in high sensitivity C-reactive protein (hsCRP)
    End point description
    Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented. The endpoint was evaluated based on the data from in-trial period which was defined as the uninterrupted time interval from the date of randomisation to the date of last contact with the study site. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to end of treatment (week 68)
    End point values
    		 Oral semaglutide 50 mg Placebo
    Number of subjects analysed
    314
    288
    Units: Ratio of hsCRP
        geometric mean (geometric coefficient of variation)
    0.42 ( 129.9 )
    0.85 ( 117.9 )
    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 75)
    Adverse event reporting additional description
    All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.

    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects received oral dose of semaglutide tablet once daily for 68 weeks. Subjects initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).

    Serious adverse events
    		 Placebo Oral semaglutide 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 333 (8.71%)
    32 / 334 (9.58%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Gastric bypass
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus operation
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 333 (0.60%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 333 (0.00%)
    4 / 334 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 333 (0.60%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    4 / 333 (1.20%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 333 (0.00%)
    2 / 334 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 333 (0.60%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 334 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 334 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Oral semaglutide 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    242 / 333 (72.67%)
    292 / 334 (87.43%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    22 / 333 (6.61%)
    10 / 334 (2.99%)
         occurrences all number
    24
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    15 / 333 (4.50%)
    27 / 334 (8.08%)
         occurrences all number
    18
    33
    Headache
         subjects affected / exposed
    29 / 333 (8.71%)
    46 / 334 (13.77%)
         occurrences all number
    36
    80
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    20 / 333 (6.01%)
    24 / 334 (7.19%)
         occurrences all number
    23
    28
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    16 / 333 (4.80%)
    25 / 334 (7.49%)
         occurrences all number
    19
    26
    Abdominal pain
         subjects affected / exposed
    16 / 333 (4.80%)
    22 / 334 (6.59%)
         occurrences all number
    19
    27
    Abdominal pain upper
         subjects affected / exposed
    12 / 333 (3.60%)
    31 / 334 (9.28%)
         occurrences all number
    16
    44
    Constipation
         subjects affected / exposed
    50 / 333 (15.02%)
    92 / 334 (27.54%)
         occurrences all number
    71
    123
    Diarrhoea
         subjects affected / exposed
    56 / 333 (16.82%)
    89 / 334 (26.65%)
         occurrences all number
    70
    169
    Dyspepsia
         subjects affected / exposed
    17 / 333 (5.11%)
    47 / 334 (14.07%)
         occurrences all number
    19
    64
    Eructation
         subjects affected / exposed
    7 / 333 (2.10%)
    32 / 334 (9.58%)
         occurrences all number
    7
    42
    Flatulence
         subjects affected / exposed
    13 / 333 (3.90%)
    19 / 334 (5.69%)
         occurrences all number
    15
    22
    Gastrooesophageal reflux disease
         subjects affected / exposed
    11 / 333 (3.30%)
    29 / 334 (8.68%)
         occurrences all number
    12
    35
    Nausea
         subjects affected / exposed
    51 / 333 (15.32%)
    173 / 334 (51.80%)
         occurrences all number
    64
    331
    Vomiting
         subjects affected / exposed
    12 / 333 (3.60%)
    80 / 334 (23.95%)
         occurrences all number
    13
    154
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    9 / 333 (2.70%)
    23 / 334 (6.89%)
         occurrences all number
    9
    25
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    38 / 333 (11.41%)
    22 / 334 (6.59%)
         occurrences all number
    42
    26
    Back pain
         subjects affected / exposed
    24 / 333 (7.21%)
    16 / 334 (4.79%)
         occurrences all number
    37
    19
    Infections and infestations
    COVID-19
         subjects affected / exposed
    115 / 333 (34.53%)
    119 / 334 (35.63%)
         occurrences all number
    121
    127
    Gastroenteritis
         subjects affected / exposed
    10 / 333 (3.00%)
    18 / 334 (5.39%)
         occurrences all number
    10
    22
    Influenza
         subjects affected / exposed
    18 / 333 (5.41%)
    26 / 334 (7.78%)
         occurrences all number
    21
    37
    Nasopharyngitis
         subjects affected / exposed
    49 / 333 (14.71%)
    38 / 334 (11.38%)
         occurrences all number
    73
    54
    Sinusitis
         subjects affected / exposed
    18 / 333 (5.41%)
    12 / 334 (3.59%)
         occurrences all number
    24
    13
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 333 (6.01%)
    19 / 334 (5.69%)
         occurrences all number
    29
    26
    Urinary tract infection
         subjects affected / exposed
    6 / 333 (1.80%)
    19 / 334 (5.69%)
         occurrences all number
    6
    27
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    24 / 333 (7.21%)
    56 / 334 (16.77%)
         occurrences all number
    26
    61

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

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