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    Clinical Trial Results:
    Investigation of clinical comparability of semaglutide drug products based on the proposed and the approved drug substance manufacturing processes in participants with type 2 diabetes

    Summary
    EudraCT number
    2021-001501-69
    Trial protocol
    SK  
    Global end of trial date
    18 Sep 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Oct 2024
    First version publication date
    02 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9535-4820
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05478252
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish clinical comparability between semaglutide J subcutaneous (s.c.) and semaglutide B s.c. on change from baseline in HbA1c at week 28 in subjects with T2D as add-on to stable dose of metformin.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, last amended by the 64th World Medical Association General Assembly, October 2013, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, including archiving of essential documents, E6(R2), Current step 4 version, 09 November 2016 and 21 CFR 312.120.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Aug 2022
    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: 30
    Country: Number of subjects enrolled
    Poland: 84
    Country: Number of subjects enrolled
    Slovakia: 65
    Country: Number of subjects enrolled
    United States: 135
    Country: Number of subjects enrolled
    South Africa: 74
    Worldwide total number of subjects
    388
    EEA total number of subjects
    149
    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)
    387
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 73 sites in Slovakia, Poland, South Africa, the United States and Canada.

    Pre-assignment
    Screening details
    Subjects were randomised in a 3:1 manner to receive either semaglutide J or semaglutide B.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Semaglutide J
    Arm description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Semaglutide J, 1.34 mg/mL, 1.5 mL compact cartridge, PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.25, 0.5 or 1.0 mg once-weekly

    Arm title
    Semaglutide B
    Arm description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Semaglutide B, 1.34 mg/mL, 1.5 mL compact cartridge, PDS290
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.25, 0.5 or 1.0 mg once-weekly

    Number of subjects in period 1
    Semaglutide J Semaglutide B
    Started
    291
    97
    Full analysis set (FAS)
    291
    97
    Safety analysis set
    291
    97
    Completed
    283
    91
    Not completed
    8
    6
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    3
         Physician decision
    1
    1
         Lost to follow-up
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide J
    Reporting group description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Reporting group title
    Semaglutide B
    Reporting group description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Reporting group values
    Semaglutide J Semaglutide B Total
    Number of subjects
    291 97 388
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    291 96 387
        From 65-84 years
    0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    53.7 ( 7.7 ) 54.8 ( 7.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    128 47 175
        Male
    163 50 213
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    27 12 39
        Native Hawaiian or Other Pacific Islander
    0 1 1
        Black or African American
    48 12 60
        White
    214 72 286
        More than one race
    2 0 2
        Unknown or Not Reported
    0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    56 25 81
        Not Hispanic or Latino
    235 72 307
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide J
    Reporting group description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Reporting group title
    Semaglutide B
    Reporting group description
    Subjects initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Primary: Change in glycosylated haemoglobin (HbA1c)

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    End point title
    Change in glycosylated haemoglobin (HbA1c)
    End point description
    Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site. Full analysis set included all randomised subjects. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    285
    91
    Units: Percentage-point
        arithmetic mean (standard deviation)
    -1.7 ( 1.0 )
    -1.6 ( 1.0 )
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
    Comparison groups
    Semaglutide J v Semaglutide B
    Number of subjects included in analysis
    376
    Analysis specification
    Post-hoc
    Analysis type
    non-inferiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    0.08

    Secondary: Number of Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Number of Treatment Emergent Adverse Events (TEAEs)
    End point description
    All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study. Safety analysis set included all subjects who are exposed to study intervention.
    End point type
    Secondary
    End point timeframe
    From the time of first dosing to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    291
    97
    Units: Events
        number (not applicable)
    408
    120
    No statistical analyses for this end point

    Secondary: Change in body weight

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    End point title
    Change in body weight
    End point description
    Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site. Full analysis set included all randomised participants. Here, "Overall Number of Subjectss Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    284
    91
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    -5.0 ( 5.0 )
    -4.6 ( 4.4 )
    No statistical analyses for this end point

    Secondary: Occurrence of anti-semaglutide antibodies (yes/no)

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    End point title
    Occurrence of anti-semaglutide antibodies (yes/no)
    End point description
    Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site. In the reported data 'yes' infers who received anti sema antibodies, whereas 'No' infers who did not receive anti sema antibodies. Safety analysis set included all subjects who are exposed to study intervention. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    282
    90
    Units: Subjects
        Yes
    1
    0
        No
    281
    90
    No statistical analyses for this end point

    Secondary: Occurence of anti-semaglutide antibodies with in-vitro neutralising effect (Yes/no)

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    End point title
    Occurence of anti-semaglutide antibodies with in-vitro neutralising effect (Yes/no)
    End point description
    Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Subjects
    Notes
    [1] - In-vitro neutralizing effect was not performed on samples with GLP-1 positive cross reactivity.
    [2] - In-vitro neutralizing effect was not performed on samples with GLP-1 positive cross reactivity.
    No statistical analyses for this end point

    Secondary: Occurence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 (Yes/no)

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    End point title
    Occurence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 (Yes/no)
    End point description
    Occurence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 from baseline (week 0) to week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralizing cross-reacting antibodies to endogenous GLP-1. Safety analysis set included all subjects who are exposed to study intervention. Here, "Overall Number of Subjectts Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    1
    0 [3]
    Units: Subjects
        Yes
    0
        No
    1
    Notes
    [3] - There were no subjects available for analysis.
    No statistical analyses for this end point

    Secondary: Occurence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) (Yes/no)

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    End point title
    Occurence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) (Yes/no)
    End point description
    Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1). Safety analysis set included all subjects who are exposed to study intervention. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    1
    0 [4]
    Units: Subjects
        Yes
    0
        No
    1
    Notes
    [4] - There were no subjects available for analysis.
    No statistical analyses for this end point

    Secondary: Anti-semaglutide antibodies level measured as percentage (%) Bound/Total

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    End point title
    Anti-semaglutide antibodies level measured as percentage (%) Bound/Total
    End point description
    Anti-semaglutide antibodies level measured as %Bound/Total from baseline (week 0) to week 33 is presented. Safety analysis set included all subjects who are exposed to study intervention. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    1
    0 [5]
    Units: %Bound/Total
        arithmetic mean (standard deviation)
    3.47 ( 0.00 )
    ( )
    Notes
    [5] - There were no subjects available for analysis.
    No statistical analyses for this end point

    Secondary: Anti-semaglutide antibodies level (measured as titre)

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    End point title
    Anti-semaglutide antibodies level (measured as titre)
    End point description
    Anti-semaglutide antibodies level measured as titre from baseline (week 0) to week 33 is presented. Safety analysis set included all subjects who are exposed to study intervention. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
    End point values
    Semaglutide J Semaglutide B
    Number of subjects analysed
    1
    0 [6]
    Units: Titre
        arithmetic mean (standard deviation)
    15.00 ( 0.00 )
    ( )
    Notes
    [6] - There were no subjects available for analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of first dosing (week 0) to end of study (week 33).
    Adverse event reporting additional description
    Treatment emergent adverse events presented, defined as adverse events with onset date (or increase in severity) during on-treatment observation period, defined as from 1st drug date until end of study. Safety analysis set: all participants who are exposed to study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Semaglutide B
    Reporting group description
    Participants initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Reporting group title
    Semaglutide J
    Reporting group description
    Participants initially received 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.

    Serious adverse events
    Semaglutide B Semaglutide J
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 97 (5.15%)
    8 / 291 (2.75%)
         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 salivary gland neoplasm
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 291 (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
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 291 (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
    Pneumonia
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Semaglutide B Semaglutide J
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 97 (24.74%)
    64 / 291 (21.99%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 97 (2.06%)
    17 / 291 (5.84%)
         occurrences all number
    2
    19
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 97 (7.22%)
    26 / 291 (8.93%)
         occurrences all number
    8
    32
    Nausea
         subjects affected / exposed
    15 / 97 (15.46%)
    35 / 291 (12.03%)
         occurrences all number
    18
    58
    Vomiting
         subjects affected / exposed
    5 / 97 (5.15%)
    15 / 291 (5.15%)
         occurrences all number
    5
    16

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jul 2022
    This version of the protocol is prepared to include additional PK samples and analyses to allow PK comparability of semaglutide J s.c. and semaglutide B s.c., based on the Health Canada’s feedback.Population pharmacokinetics will be addressed in a modelling analysis plan and the totality of evidence from all PK assessments will be presented as a collective whole in a comprehensive modelling report. Therefore, secondary PK objective has been removed from the protocol.
    06 Dec 2022
    This change has been made to increase the robustness and acceptability of the primary assessment and is based on recommendations from Health Authority. This is to maintain 80% power under the non-inferiority analysis that does not utilize historical data. This has been done to simplify and provide more clarity. This has been done to correct spelling mistake.This has been removed as it is no longer defined in the protocol.
    07 Jun 2023
    This has been done to correct wrong specification. This has been done in accordance with feedback received from health authority. This has been done in accordance with the change of the estimands. This has been done to preserve the conservatism of the primary analysis and is aligned with feedback received from health authority. This has been done to correct the time range for sampling. This has been done to maintain consistency between Section 4.3 and Section 6.1. This has been removed as it is no longer defined in protocol.

    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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