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    Clinical Trial Results:
    Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity

    Summary
    EudraCT number
    		 2017-003436-36
    Trial protocol
    		 GB   FI   DK   BG   BE   PL  
    Global end of trial date
    05 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Apr 2022
    First version publication date
    19 Feb 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9536-4373
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03548935
    WHO universal trial number (UTN)
    		 U1111-1200-8053
    Other trial identifiers
    		 JapicCTI: JapicCTI-183991
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsværd, Denmark, 2880
    Public contact
    Clinical Reporting Office (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (1452), 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
    28 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of semaglutide subcutaneous (s.c.) 2.4 mg once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (2016) and Food and Drug Administration 21 Code of Federal Regulations 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    04 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 65
    Country: Number of subjects enrolled
    Belgium: 60
    Country: Number of subjects enrolled
    Bulgaria: 45
    Country: Number of subjects enrolled
    Canada: 63
    Country: Number of subjects enrolled
    Germany: 100
    Country: Number of subjects enrolled
    Denmark: 50
    Country: Number of subjects enrolled
    Finland: 60
    Country: Number of subjects enrolled
    France: 55
    Country: Number of subjects enrolled
    United Kingdom: 218
    Country: Number of subjects enrolled
    India: 117
    Country: Number of subjects enrolled
    Japan: 100
    Country: Number of subjects enrolled
    Mexico: 70
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Russian Federation: 100
    Country: Number of subjects enrolled
    Taiwan: 35
    Country: Number of subjects enrolled
    United States: 763
    Worldwide total number of subjects
    1961
    EEA total number of subjects
    430
    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)
    1805
    From 65 to 84 years
    155
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 129 sites in 16 countries as follows: Argentina (5), Belgium (5), Bulgaria (5), Canada (7), Denmark (1), Finland (2), France (7), Germany (13), India (13), Japan (5), Mexico (3), Poland (4), Russian Federation (8), Taiwan (1), United Kingdom (10), United States (40).

    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 2:1 ratio either to receive semaglutide 2.4 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
    Blinding implementation details
    Semaglutide and placebo were identical in appearance and were packed and labelled to fulfil the requirements for double-blind procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 2.4 mg
    Arm description
    		 Subjects were to receive once-weekly subcutaneous (s.c) injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide 3.0 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once-weekly s.c injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 3.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. Injections were administered in the thigh, abdomen or upper arm, and at any time of the day irrespective of meals.

    Investigational medicinal product name
    Semaglutide 1.0 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once-weekly s.c injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. Injections were administered in the thigh, abdomen or upper arm, and at any time of the day irrespective of meals.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were to receive once-weekly s.c injection of placebo matched to Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL for week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Semaglutide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once-weekly s.c injection of 0.25 mg Semaglutide placebo was administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge. Dosing was once weekly with dose escalation every fourth week until the maintenance dose was reached. Injections could be administered in the thigh, abdomen or upper arm, and at any time of the day irrespective of meals.

    Number of subjects in period 1
    		Semaglutide 2.4 mg Placebo
    Started
    1306
    655
    Full analysis set (FAS)
    1306
    655
    Safety analysis set (SAS)
    1306
    655
    Completed
    1240
    609
    Not completed
    66
    46
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    26
    17
         Lost to follow-up
    39
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects were to receive once-weekly subcutaneous (s.c) injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once-weekly s.c injection of placebo matched to Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL for week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Reporting group values
    		 Semaglutide 2.4 mg Placebo Total
    Number of subjects
    		 1306 655 1961
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ( 13 ) 47 ( 12 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 955 498 1453
        Male
    		 351 157 508

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects were to receive once-weekly subcutaneous (s.c) injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once-weekly s.c injection of placebo matched to Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL for week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Primary: 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 week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which subjects are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). Full analysis set (FAS) included all randomised subjects according to the intention-to-treat principle.
    End point type
    Primary
    End point timeframe
    From baseline at week 0 to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1212
    577
    Units: Percentage point
    arithmetic mean (standard deviation)
        In-trial observation period
    -15.6 ( 10.1 )
    -2.8 ( 6.5 )
        On-treatment observation period
    -16.9 ( 9.4 )
    -3.1 ( 6.4 )
    Statistical analysis title
    		 Semaglutide 2.4 mg versus Placebo
    Statistical analysis description
    Analysis of data from in-trial period. ANCOVA: Week 68 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. RD-MI: Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm. All subjects in FAS (1961 subjects) contributed to the analysis.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    1789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -12.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.37
         upper limit
    		 -11.51
    Notes
    [1] - Treatment policy estimand
    Statistical analysis title
    		 Semaglutide 2.4 mg versus Placebo
    Statistical analysis description
    Analysis of data from on-treatment period. Time-point considered as on-treatment if any dose of trial product has been administered within prior 14 days. MMRM: 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. All subjects in FAS (1961) contributed to the analysis.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    1789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 MMRM
    Parameter type
    		 Treatment difference
    Point estimate
    -14.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.29
         upper limit
    		 -13.55
    Notes
    [2] - Hypothetical estimand

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

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    End point title
    		 Subjects who achieve body weight reduction ≥ 5% (yes/no)
    End point description
    Number of subjects who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which subjects are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Primary
    End point timeframe
    After 68 weeks from baseline at week 0
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1212
    577
    Units: Subjects
        In-trial observation period: Yes
    1047
    182
        In-trial observation period: No
    165
    395
        On-treatment observation period: Yes
    978
    165
        On-treatment observation period: No
    81
    334
    Statistical analysis title
    		 Semaglutide 2.4 mg versus Placebo
    Statistical analysis description
    Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment as factor and baseline body weight as covariate. RD-MI: Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm. All subjects in FAS (1961 subjects) contributed to the analysis.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    1789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.88
         upper limit
    		 14.19
    Notes
    [3] - Treatment policy estimand
    Statistical analysis title
    		 Semaglutide 2.4 mg versus Placebo
    Statistical analysis description
    Analysis of data from on-treatment period. MMRM was performed on body weight (kg) and individual missing week 68 responses were predicted from the MMRM; each subject was then classified for body weight loss >= 5% and analysed using a binary logistic regression (LR) model with randomised treatment as factor and baseline body weight as covariate. All subjects in FAS (1961 subjects) contributed to the analysis.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    1789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    37.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.02
         upper limit
    		 48.95
    Notes
    [4] - Hypothetical estimand

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

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    End point title
    		 Subjects who achieve (yes/no) body weight reduction ≥ 10%
    End point description
    Number of subjects who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    After 68 weeks from baseline at week 0
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1212
    577
    Units: Subjects
        Yes
    838
    69
        No
    374
    508
    No statistical analyses for this end point

    Secondary: Subjects who achieve (yes/no) body weight reduction ≥ 15%

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    End point title
    		 Subjects who achieve (yes/no) body weight reduction ≥ 15%
    End point description
    Number of subjects who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    After 68 weeks from baseline at week 0
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1212
    577
    Units: Subjects
        Yes
    612
    28
        No
    600
    549
    No statistical analyses for this end point

    Secondary: Change in waist circumference (cm)

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    End point title
    		 Change in waist circumference (cm)
    End point description
    Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    From baseline at week 0 to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1210
    575
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    -14.1 ( 9.6 )
    -4.4 ( 6.9 )
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure (mmHg)

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    End point title
    		 Change in systolic blood pressure (mmHg)
    End point description
    Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    From baseline at week 0 to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1210
    574
    Units: Millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    -7 ( 14 )
    -1 ( 13 )
    No statistical analyses for this end point

    Secondary: Change in Physical functioning score (SF-36)

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    End point title
    		 Change in Physical functioning score (SF-36)
    End point description
    Short Form 36 version 2.0 acute (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 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 observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    From baseline at week 0 to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1195
    566
    Units: Score on a scale
        arithmetic mean (standard deviation)
    2.3 ( 6.6 )
    0.4 ( 7.4 )
    No statistical analyses for this end point

    Secondary: Change in physical function domain (5-items) score (IWQoL-Lite for CT)

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    End point title
    		 Change in physical function domain (5-items) score (IWQoL-Lite for CT)
    End point description
    Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoL-Lite-CT) is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients’ physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. This endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). FAS included all randomised subjects according to the intention-to-treat principle.
    End point type
    Secondary
    End point timeframe
    From baseline at week 0 to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    1193
    566
    Units: Score on a scale
        arithmetic mean (standard deviation)
    15.0 ( 21.6 )
    6.0 ( 21.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.
    Adverse event reporting additional description
    All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects were to receive once-weekly subcutaneous (s.c) injection of Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL at a starting dose of 0.25 milligrams (mg) and then followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once-weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once-weekly s.c injection of placebo matched to Semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL for week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.

    Serious adverse events
    		 Semaglutide 2.4 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    128 / 1306 (9.80%)
    42 / 655 (6.41%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma stage 0
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hairy cell leukaemia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominoplasty
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone prosthesis insertion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip surgery
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    Hypersensitivity
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 655 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 655 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Lipase increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 655 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS origin
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    Meniere's disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    4 / 1306 (0.31%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    12 / 1306 (0.92%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    2 / 12
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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
    Actinic keratosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hidradenitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia intercostal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 655 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 1306 (0.38%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial colitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (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 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 1306 (0.38%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis astroviral
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 655 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxoplasmosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 655 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 655 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide 2.4 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1052 / 1306 (80.55%)
    447 / 655 (68.24%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    98 / 1306 (7.50%)
    23 / 655 (3.51%)
         occurrences all number
    129
    35
    Headache
         subjects affected / exposed
    198 / 1306 (15.16%)
    80 / 655 (12.21%)
         occurrences all number
    386
    104
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    104 / 1306 (7.96%)
    28 / 655 (4.27%)
         occurrences all number
    120
    29
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    127 / 1306 (9.72%)
    36 / 655 (5.50%)
         occurrences all number
    172
    41
    Abdominal distension
         subjects affected / exposed
    96 / 1306 (7.35%)
    31 / 655 (4.73%)
         occurrences all number
    135
    42
    Abdominal pain upper
         subjects affected / exposed
    125 / 1306 (9.57%)
    35 / 655 (5.34%)
         occurrences all number
    176
    37
    Constipation
         subjects affected / exposed
    305 / 1306 (23.35%)
    62 / 655 (9.47%)
         occurrences all number
    389
    73
    Diarrhoea
         subjects affected / exposed
    411 / 1306 (31.47%)
    104 / 655 (15.88%)
         occurrences all number
    765
    138
    Dyspepsia
         subjects affected / exposed
    135 / 1306 (10.34%)
    23 / 655 (3.51%)
         occurrences all number
    179
    30
    Eructation
         subjects affected / exposed
    112 / 1306 (8.58%)
    3 / 655 (0.46%)
         occurrences all number
    139
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    82 / 1306 (6.28%)
    20 / 655 (3.05%)
         occurrences all number
    92
    21
    Nausea
         subjects affected / exposed
    576 / 1306 (44.10%)
    114 / 655 (17.40%)
         occurrences all number
    1067
    146
    Vomiting
         subjects affected / exposed
    321 / 1306 (24.58%)
    43 / 655 (6.56%)
         occurrences all number
    632
    52
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    40 / 1306 (3.06%)
    33 / 655 (5.04%)
         occurrences all number
    45
    35
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    81 / 1306 (6.20%)
    43 / 655 (6.56%)
         occurrences all number
    92
    47
    Back pain
         subjects affected / exposed
    106 / 1306 (8.12%)
    53 / 655 (8.09%)
         occurrences all number
    120
    55
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    81 / 1306 (6.20%)
    30 / 655 (4.58%)
         occurrences all number
    99
    38
    Influenza
         subjects affected / exposed
    89 / 1306 (6.81%)
    63 / 655 (9.62%)
         occurrences all number
    112
    79
    Nasopharyngitis
         subjects affected / exposed
    281 / 1306 (21.52%)
    133 / 655 (20.31%)
         occurrences all number
    480
    216
    Sinusitis
         subjects affected / exposed
    70 / 1306 (5.36%)
    36 / 655 (5.50%)
         occurrences all number
    83
    40
    Upper respiratory tract infection
         subjects affected / exposed
    114 / 1306 (8.73%)
    80 / 655 (12.21%)
         occurrences all number
    158
    116
    Urinary tract infection
         subjects affected / exposed
    68 / 1306 (5.21%)
    28 / 655 (4.27%)
         occurrences all number
    83
    33
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    124 / 1306 (9.49%)
    22 / 655 (3.36%)
         occurrences all number
    139
    26

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2018
    Implementation of genetic biosamples for future analysis for those countries where it will be applicable. Removal of criteria for discontinuation of trial treatment for subjects included in the trial in violation of the inclusion and/or exclusion criteria and/or randomisation criteria. Classifications of risks have been removed from the protocol and instead a reference to the investigator’s brochure or any updates hereof has been added for further details of the risks associated with semaglutide treatment.
    09 May 2019
    Trial extension: 52-weeks off-treatment period after end of treatment in the main phase without structured lifestyle intervention in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30122305
    http://www.ncbi.nlm.nih.gov/pubmed/32441473
    http://www.ncbi.nlm.nih.gov/pubmed/33567185
    For support, Contact us.
    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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