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

    Summary
    EudraCT number
    		 2017-003726-32
    Trial protocol
    		 HU   ES   IT  
    Global end of trial date
    23 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2022
    First version publication date
    31 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9536-4378
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03693430
    WHO universal trial number (UTN)
    		 U1111-1202-1740
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the two-year effect of semaglutide subcutaneous (s.c) 2.4 milligram (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), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (2016) and US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 312.120.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 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
    Canada: 51
    Country: Number of subjects enrolled
    Spain: 50
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    Italy: 45
    Country: Number of subjects enrolled
    United States: 123
    Worldwide total number of subjects
    304
    EEA total number of subjects
    130
    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)
    285
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 41 sites in 5 countries as follows: Canada (9 sites), Hungary (6 sites), Italy (5 sites), Spain (6 sites), and United States (15 sites).

    Pre-assignment
    Screening details
    		 Subjects were randomized in a 1:1 manner to receive treatment with semaglutide 2.4 milligram (mg) or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 104 weeks treatment period (16 weeks of dose escalation period and 88 weeks of maintenance dose).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide 2.4 mg
    Arm description
    		 Subjects received once-weekly s.c. injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    PDS290
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
    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
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

    Number of subjects in period 1
    		Semaglutide 2.4 mg Placebo
    Started
    152
    152
    Full analysis set (FAS)
    152
    152
    Safety analysis set (SAS)
    152
    152
    Completed
    148
    134
    Not completed
    4
    18
         Consent withdrawn by subject
    -
    4
         Death
    1
    -
         Lost to follow-up
    3
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received once-weekly s.c. injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

    Reporting group values
    		 Semaglutide 2.4 mg Placebo Total
    Number of subjects
    		 152 152 304
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ± 12 47 ± 10 -
    Gender Categorical
    Units: Subjects
        Female
    		 123 113 236
        Male
    		 29 39 68

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received once-weekly s.c. injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

    Subject analysis set title
    Semaglutide 2.4 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

    Primary: Change in body weight (%)

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    End point title
    		 Change in body weight (%)
    End point description
    Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment). The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed = subjects with available data for this endpoint and Number Analyzed = subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 104
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    144
    128
    Units: Percentage change
    arithmetic mean (standard deviation)
        In-trial observation period
    -15.9 ± 12.3
    -1.9 ± 8.9
        On-treatment observation period (n= -132, 109)
    -17.3 ± 11.9
    -2.0 ± 8.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. 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
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -12.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.33
         upper limit
    		 -9.77
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 MMRM (Mixed model repeated measurement)
    Parameter type
    		 Treatment difference
    Point estimate
    -16.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.64
         upper limit
    		 -13.45
    Notes
    [1] - The number of subjects in this analysis is auto-calculated by the system. The actual number of subjects in the analysis are 211.

    Primary: Subjects who achieve (yes/no): Body weight reduction equal to or above 5%

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    End point title
    		 Subjects who achieve (yes/no): Body weight reduction equal to or above 5%
    End point description
    Number of subjects who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of subjects who have achieved >=5% weight loss, whereas 'No' infers the number of subjects who have not achieved >=5% weight loss. The endpoint was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment). The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed= subjects with available data for this endpoint and Number Analyzed= subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 104
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    144
    128
    Units: Subjects
        In-trial observation period: Yes
    111
    44
        In-trial observation period: No
    33
    84
        On-treatment observation period: Yes (n= 132, 109)
    110
    38
        On-treatment observation period: No (n= 132, 109)
    22
    71
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Treatment policy estimand.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.95
         upper limit
    		 8.42
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Hypothetical estimand.
    Comparison groups
    Semaglutide 2.4 mg v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 MMRM
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    18.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.04
         upper limit
    		 32.49
    Notes
    [2] - The number of subjects in this analysis is auto-calculated by the system. The actual number of subjects in the analysis are 211.

    Secondary: Subjects who achieve (yes/no): Body weight reduction equal to or above 10% from baseline (week 0)

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    End point title
    		 Subjects who achieve (yes/no): Body weight reduction equal to or above 10% from baseline (week 0)
    End point description
    Number of subjects who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of subjects who have achieved >=10% weight loss, whereas 'No' infers the number of subjects who have not achieved >=10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    After 104 weeks
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    144
    128
    Units: Subjects
        Yes
    89
    17
        No
    55
    111
    No statistical analyses for this end point

    Secondary: Subjects who achieve (yes/no): Body weight reduction equal to or above 15% from baseline (week 0)

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    End point title
    		 Subjects who achieve (yes/no): Body weight reduction equal to or above 15% from baseline (week 0)
    End point description
    Number of subjects who achieved >=15% weight loss at 154 weeks is presented. In the reported data, 'Yes' infers the number of subjects who have achieved >=15% weight loss, whereas 'No' infers the number of subjects who have not achieved >=15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    After 104 weeks
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    144
    128
    Units: Subjects
        Yes
    75
    9
        No
    69
    119
    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 104 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 104
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    143
    126
    Units: Centimetre (cm)
        arithmetic mean (standard deviation)
    -15.2 ± 12.4
    -4.3 ± 9.1
    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 104 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. The FAS included all randomised subjects according to the intention-to-treat principle. Overall Number of Subjects Analyzed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 104
    End point values
    		 Semaglutide 2.4 mg Placebo
    Number of subjects analysed
    142
    125
    Units: Millimetre of mercury (mmHg)
        arithmetic mean (standard deviation)
    -6 ± 13
    -1 ± 15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Week 0) to Week 111
    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. Results are based on the SAS which included all randomised subjects exposed to at least one dose of randomised treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

    Reporting group title
    Semaglutide 2.4 mg
    Reporting group description
    		 Subjects received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

    Serious adverse events
    		 Placebo Semaglutide 2.4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 152 (11.84%)
    12 / 152 (7.89%)
         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)
    Benign uterine neoplasm
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Thyroidectomy
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic disorder
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cervical cord compression
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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
    Anal abscess
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 152 (1.32%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 152 (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
    		 Placebo Semaglutide 2.4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    117 / 152 (76.97%)
    141 / 152 (92.76%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 152 (0.66%)
    10 / 152 (6.58%)
         occurrences all number
    1
    10
    Vascular disorders
    Hypertension
         subjects affected / exposed
    14 / 152 (9.21%)
    6 / 152 (3.95%)
         occurrences all number
    14
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 152 (5.26%)
    13 / 152 (8.55%)
         occurrences all number
    12
    16
    Headache
         subjects affected / exposed
    16 / 152 (10.53%)
    16 / 152 (10.53%)
         occurrences all number
    31
    36
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 152 (1.32%)
    8 / 152 (5.26%)
         occurrences all number
    3
    10
    Fatigue
         subjects affected / exposed
    8 / 152 (5.26%)
    11 / 152 (7.24%)
         occurrences all number
    8
    12
    Injection site bruising
         subjects affected / exposed
    8 / 152 (5.26%)
    5 / 152 (3.29%)
         occurrences all number
    11
    8
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    9 / 152 (5.92%)
    15 / 152 (9.87%)
         occurrences all number
    13
    22
    Abdominal pain
         subjects affected / exposed
    4 / 152 (2.63%)
    20 / 152 (13.16%)
         occurrences all number
    14
    32
    Abdominal pain upper
         subjects affected / exposed
    10 / 152 (6.58%)
    22 / 152 (14.47%)
         occurrences all number
    13
    23
    Constipation
         subjects affected / exposed
    17 / 152 (11.18%)
    47 / 152 (30.92%)
         occurrences all number
    26
    62
    Diarrhoea
         subjects affected / exposed
    36 / 152 (23.68%)
    53 / 152 (34.87%)
         occurrences all number
    51
    108
    Dyspepsia
         subjects affected / exposed
    7 / 152 (4.61%)
    20 / 152 (13.16%)
         occurrences all number
    12
    24
    Eructation
         subjects affected / exposed
    1 / 152 (0.66%)
    17 / 152 (11.18%)
         occurrences all number
    2
    21
    Flatulence
         subjects affected / exposed
    10 / 152 (6.58%)
    20 / 152 (13.16%)
         occurrences all number
    11
    25
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 152 (3.95%)
    15 / 152 (9.87%)
         occurrences all number
    6
    19
    Nausea
         subjects affected / exposed
    33 / 152 (21.71%)
    81 / 152 (53.29%)
         occurrences all number
    53
    213
    Vomiting
         subjects affected / exposed
    7 / 152 (4.61%)
    46 / 152 (30.26%)
         occurrences all number
    8
    78
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 152 (5.26%)
    8 / 152 (5.26%)
         occurrences all number
    10
    8
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    11 / 152 (7.24%)
    8 / 152 (5.26%)
         occurrences all number
    12
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 152 (7.24%)
    14 / 152 (9.21%)
         occurrences all number
    20
    20
    Back pain
         subjects affected / exposed
    19 / 152 (12.50%)
    15 / 152 (9.87%)
         occurrences all number
    20
    17
    Osteoarthritis
         subjects affected / exposed
    8 / 152 (5.26%)
    9 / 152 (5.92%)
         occurrences all number
    9
    10
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    8 / 152 (5.26%)
    8 / 152 (5.26%)
         occurrences all number
    9
    9
    COVID-19
         subjects affected / exposed
    6 / 152 (3.95%)
    15 / 152 (9.87%)
         occurrences all number
    6
    16
    Gastroenteritis
         subjects affected / exposed
    4 / 152 (2.63%)
    20 / 152 (13.16%)
         occurrences all number
    4
    28
    Influenza
         subjects affected / exposed
    16 / 152 (10.53%)
    20 / 152 (13.16%)
         occurrences all number
    19
    23
    Nasopharyngitis
         subjects affected / exposed
    23 / 152 (15.13%)
    24 / 152 (15.79%)
         occurrences all number
    31
    33
    Sinusitis
         subjects affected / exposed
    9 / 152 (5.92%)
    8 / 152 (5.26%)
         occurrences all number
    9
    8
    Upper respiratory tract infection
         subjects affected / exposed
    23 / 152 (15.13%)
    20 / 152 (13.16%)
         occurrences all number
    30
    31
    Urinary tract infection
         subjects affected / exposed
    6 / 152 (3.95%)
    12 / 152 (7.89%)
         occurrences all number
    7
    19
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 152 (3.95%)
    17 / 152 (11.18%)
         occurrences all number
    6
    18

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2018
    Inclusion of the Control of Eating Questionnaire (CoEQ) as an exploratory endpoint.

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

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

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