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    Clinical Trial Results:
    Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity who have reached target dose during run-in period

    Summary
    EudraCT number
    		 2017-003473-34
    Trial protocol
    		 SE   NL   PT   DK   ES  
    Global end of trial date
    20 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9536-4376
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03548987
    WHO universal trial number (UTN)
    		 U1111-1201-0898
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, +1 866 8677178, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, +1 866 8677178, 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
    16 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, on body weight.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) ICH Good Clinical Practice (2016) and FDA 21 CFR 312.120.
    Background therapy
    		 -
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 69
    Country: Number of subjects enrolled
    Denmark: 60
    Country: Number of subjects enrolled
    Spain: 70
    Country: Number of subjects enrolled
    Israel: 60
    Country: Number of subjects enrolled
    Netherlands: 42
    Country: Number of subjects enrolled
    Portugal: 35
    Country: Number of subjects enrolled
    Sweden: 49
    Country: Number of subjects enrolled
    Ukraine: 66
    Country: Number of subjects enrolled
    United States: 381
    Country: Number of subjects enrolled
    South Africa: 70
    Worldwide total number of subjects
    902
    EEA total number of subjects
    256
    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)
    844
    From 65 to 84 years
    58
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted in 73 sites in Denmark (2), Israel (6), Netherlands (3), Portugal (6), South Africa (6), Spain (7), Sweden (4), Switzerland (6), Ukraine (5), and United States (28).

    Pre-assignment
    Screening details
    		 Subjects started with Semaglutide 0.25 mg dose from week 0 to 20 (run-in period) and the dose was increased every 4th week until 2.4 mg was reached. The run-in completers were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo till 48 weeks. The treatment is an adjunct to reduced-calorie diet and increased physical activity.

    Period 1
    Period 1 title
    Run-in period (week 0 to week 20)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial products Semaglutide B 1.0 mg/mL and Semaglutide B 3.0 mg/mL were packed open labelled during the run-in period (0-20 weeks)

    Arms
    Arm title
    		 Semaglutide
    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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Semaglutide B 1.0 mg/mL PDS290, Semaglutide B 3.0 mg/mL PDS290
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg

    Number of subjects in period 1
    		Semaglutide
    Started
    902
    Completed
    803
    Not completed
    99
         Consent withdrawn by subject
    11
         Adverse event, non-fatal
    48
         Other
    9
         Pregnancy
    1
         Run-in failure
    19
         Lost to follow-up
    8
         Safety concern as judged by investigator
    2
         Protocol deviation
    1
    Period 2
    Period 2 title
    Maintenance period (week 20 to week 68)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Semaglutide ((Semaglutide B 3.0 mg/mL PDS290) and placebo were identical in appearance and were packed and labelled to fulfil the requirements for double-blind procedures. The subjects, investigators and Novo Nordisk remained blinded during the randomised (maintenance) period and follow-up period and until after data base lock (DBL).

    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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B 3.0 mg/mL PDS290
    Investigational medicinal product code
    Other name
    semaglutide
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2.4 mg/week

    Arm title
    		 Placebo
    Arm description
    		 Subjects were to receive 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 or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    semaglutide placebo
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2.4 mg/week

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: To comply with the aim of the withdrawal trial design, the period 2 (week 20 to week 68) was considered as baseline since the subjects who have reached the target dose of semaglutide during period 1 (week 0 to week 20) were randomised at week 20 to receive either semaglutide or placebo.
    Number of subjects in period 2 [2]
    		Semaglutide 2.4 mg Placebo
    Started
    535
    268
    Completed
    504
    237
    Not completed
    31
    31
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    13
    6
         Other
    12
    23
         Pregnancy
    2
    -
         Lost to follow-up
    2
    1
         Protocol deviation
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out 902 subjects who were enrolled worldwide, 99 subjects have not completed the run-in period (0-20 weeks). Thus, 803 subjects who have completed run-in were randomised in baseline period (20-68 weeks).

    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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive 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 or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.

    Reporting group values
    		 Semaglutide 2.4 mg Placebo Total
    Number of subjects
    		 535 268 803
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 503 252 755
        From 65-84 years
    		 32 16 48
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 12 ) 46 ( 12 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 429 205 634
        Male
    		 106 63 169

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide
    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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
    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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive 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 or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.

    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 20) 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 start of run-in (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. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
    End point type
    Primary
    End point timeframe
    From randomisation (week 20) to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    520
    250
    Units: Percentage point
    arithmetic mean (standard deviation)
        In-trial observation period
    -8.3 ( 8.1 )
    6.5 ( 7.7 )
        On-treatment observation period
    -8.8 ( 7.8 )
    6.1 ( 7.7 )
    Statistical analysis title
    		 Semaglutide 2.4 mg vs Placebo
    Statistical analysis description
    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.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -14.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16
         upper limit
    		 -13.5
    Notes
    [1] - Treatment policy estimand
    Statistical analysis title
    		 Semaglutide 2.4 mg vs Placebo
    Statistical analysis description
    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.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    770
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -15.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.52
         upper limit
    		 -14.13
    Notes
    [2] - Hypothetical estimand

    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 20) 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 run-in (week 0) to last trial-related subject-site contact (week 75).
    End point type
    Secondary
    End point timeframe
    From randomisation (week 20) to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    518
    248
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    -6.9 ( 7.5 )
    3.2 ( 7.0 )
    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 week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).
    End point type
    Secondary
    End point timeframe
    From randomisation (week 20) to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    518
    248
    Units: Millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    0 ( 14 )
    5 ( 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
    SF-36 is a 36-item patient-reported survey of patient health that measures the subject'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). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 20 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
    End point type
    Secondary
    End point timeframe
    From randomisation (week 20) to week 68
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    515
    245
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change in physical functioning score (SF-36)
    1.0 ( 3.8 )
    -1.2 ( 4.5 )
    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 subjects 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 randomised 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: Run-in period
    Reporting group description
    		 Subjects were to receive 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 or 3.0 mg/mL in run-in period (week 0 to week 20) with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.

    Reporting group title
    Semaglutide 2.4: Treatment period
    Reporting group description
    		 Subjects were to receive 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 or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 535 subjects were continued to receive once weekly semaglutide s.c 2.4 mg until week 68.

    Reporting group title
    Placebo: treatment period
    Reporting group description
    		 Subjects were to receive 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 or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The subjects with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 268 subjects were switched to receive once weekly placebo until week 68.

    Serious adverse events
    		 Semaglutide: Run-in period Semaglutide 2.4: Treatment period Placebo: treatment period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 902 (2.33%)
    41 / 535 (7.66%)
    15 / 268 (5.60%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer stage II
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Marginal zone lymphoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arthroscopic surgery
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthognathic surgery
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Morning sickness
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Lead dislodgement
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Corneal abrasion
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 902 (0.22%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparaesthesia
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 902 (0.00%)
    2 / 535 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quadriplegia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 902 (0.11%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 902 (0.22%)
    1 / 535 (0.19%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary cyst
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 902 (0.00%)
    5 / 535 (0.93%)
    2 / 268 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 902 (0.22%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 902 (0.33%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 902 (0.00%)
    2 / 535 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Induced abortion infection
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 902 (0.00%)
    0 / 535 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 902 (0.11%)
    0 / 535 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 902 (0.00%)
    1 / 535 (0.19%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide: Run-in period Semaglutide 2.4: Treatment period Placebo: treatment period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    670 / 902 (74.28%)
    295 / 535 (55.14%)
    114 / 268 (42.54%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    96 / 902 (10.64%)
    41 / 535 (7.66%)
    10 / 268 (3.73%)
         occurrences all number
    119
    48
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    67 / 902 (7.43%)
    26 / 535 (4.86%)
    6 / 268 (2.24%)
         occurrences all number
    69
    29
    6
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    50 / 902 (5.54%)
    8 / 535 (1.50%)
    2 / 268 (0.75%)
         occurrences all number
    53
    10
    2
    Abdominal pain
         subjects affected / exposed
    67 / 902 (7.43%)
    34 / 535 (6.36%)
    8 / 268 (2.99%)
         occurrences all number
    82
    45
    9
    Abdominal pain upper
         subjects affected / exposed
    49 / 902 (5.43%)
    20 / 535 (3.74%)
    3 / 268 (1.12%)
         occurrences all number
    64
    22
    3
    Constipation
         subjects affected / exposed
    200 / 902 (22.17%)
    62 / 535 (11.59%)
    16 / 268 (5.97%)
         occurrences all number
    232
    75
    18
    Diarrhoea
         subjects affected / exposed
    212 / 902 (23.50%)
    77 / 535 (14.39%)
    19 / 268 (7.09%)
         occurrences all number
    309
    114
    26
    Dyspepsia
         subjects affected / exposed
    103 / 902 (11.42%)
    9 / 535 (1.68%)
    2 / 268 (0.75%)
         occurrences all number
    127
    9
    2
    Eructation
         subjects affected / exposed
    71 / 902 (7.87%)
    14 / 535 (2.62%)
    1 / 268 (0.37%)
         occurrences all number
    88
    15
    1
    Flatulence
         subjects affected / exposed
    50 / 902 (5.54%)
    14 / 535 (2.62%)
    3 / 268 (1.12%)
         occurrences all number
    73
    44
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    58 / 902 (6.43%)
    5 / 535 (0.93%)
    1 / 268 (0.37%)
         occurrences all number
    60
    6
    1
    Nausea
         subjects affected / exposed
    422 / 902 (46.78%)
    75 / 535 (14.02%)
    13 / 268 (4.85%)
         occurrences all number
    629
    104
    13
    Vomiting
         subjects affected / exposed
    140 / 902 (15.52%)
    54 / 535 (10.09%)
    8 / 268 (2.99%)
         occurrences all number
    239
    87
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 902 (2.33%)
    25 / 535 (4.67%)
    14 / 268 (5.22%)
         occurrences all number
    23
    28
    16
    Back pain
         subjects affected / exposed
    26 / 902 (2.88%)
    28 / 535 (5.23%)
    18 / 268 (6.72%)
         occurrences all number
    28
    32
    19
    Infections and infestations
    Influenza
         subjects affected / exposed
    28 / 902 (3.10%)
    39 / 535 (7.29%)
    19 / 268 (7.09%)
         occurrences all number
    28
    45
    23
    Nasopharyngitis
         subjects affected / exposed
    92 / 902 (10.20%)
    58 / 535 (10.84%)
    39 / 268 (14.55%)
         occurrences all number
    102
    77
    54
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    102 / 902 (11.31%)
    7 / 535 (1.31%)
    0 / 268 (0.00%)
         occurrences all number
    115
    7
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2018
    This protocol is amended for the following reasons: 1. 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. Subjects will not be discontinued from trial product if considered safe to continue. However, prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted and deviations from the protocol should be avoided. 2. Classifications of risks have been removed from the protocol and instead a reference to the IB or any updates hereof has been added for further details of the risks associated with semaglutide treatment. 3. Minor clarification of content and correction of minor errors and typos.

    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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