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    Clinical Trial Results:
    Investigation of the safety and efficacy of semaglutide s.c. in combination with NNC0480-0389 in participants with type 2 diabetes-a dose finding study.

    Summary
    EudraCT number
    2020-004863-14
    Trial protocol
    DK   HU   GR   BG  
    Global end of trial date
    23 Mar 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Apr 2024
    First version publication date
    07 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9389-4606
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05144984
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Japanese trial registration: jRCT2031210474
    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
    02 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of subcutaneously co administered semaglutide and NNC0480-0389 (in different dose ratios) versus placebo on change in HbA1c from baseline to week 34 in subjects with Type 2 Diabetes inadequately controlled on diet and exercise with or without 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
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    29 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 55
    Country: Number of subjects enrolled
    Denmark: 18
    Country: Number of subjects enrolled
    Greece: 57
    Country: Number of subjects enrolled
    Hungary: 74
    Country: Number of subjects enrolled
    Japan: 55
    Country: Number of subjects enrolled
    Poland: 87
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Serbia: 28
    Country: Number of subjects enrolled
    United States: 119
    Worldwide total number of subjects
    500
    EEA total number of subjects
    291
    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)
    353
    From 65 to 84 years
    147
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted in 9 countries (86 sites screened/83 randomised subjects): Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35.

    Pre-assignment
    Screening details
    The trial had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
    Arm description
    Subjects received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0480-0389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4 mg NNC0480-0389 subcutaneously for 34 weeks.

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4 mg semaglutide subcutaneously for 34 weeks.

    Arm title
    Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
    Arm description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0480-0389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 7.2 mg NNC0480-0389 subcutaneously for 34 weeks.

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4 mg semaglutide subcutaneously for 34 weeks.

    Arm title
    Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
    Arm description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0480-0389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 12.0 mg NNC0480-0389 subcutaneously for 34 weeks.

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4mg semaglutide subcutaneously for 34 weeks.

    Arm title
    Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
    Arm description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0480-0389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 21.6 mg NNC0480-0389 subcutaneously for 34 weeks.

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4mg semaglutide subcutaneously for 34 weeks.

    Arm title
    Semaglutide 2.4 mg + placebo (NNC0480-0389)
    Arm description
    Subjects received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 2.4 mg semaglutide subcutaneously for 34 weeks.

    Investigational medicinal product name
    Placebo (NNC0480-0389)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly placebo (NNC0480-0389) subcutaneously for 34 weeks.

    Arm title
    NNC0480-0389 21.6 mg + placebo (semaglutide)
    Arm description
    Subjects received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (semaglutide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly placebo (semaglutide) subcutaneously for 34 weeks.

    Investigational medicinal product name
    NNC0480-0389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received once weekly 21.6 mg NNC0480-0389 subcutaneously for 34 weeks.

    Arm title
    Placebo
    Arm description
    Subjects received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    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 subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo for 34 weeks.

    Number of subjects in period 1
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Started
    77
    74
    77
    77
    75
    59
    61
    Exposed
    77
    74
    77
    77
    75
    59
    61
    Full Analysis Set (FAS)
    77
    74
    77
    77
    75
    59
    61
    Safety Analysis Set (SAS)
    77
    74
    77
    77
    75
    59
    61
    Completed
    74
    72
    74
    74
    72
    57
    59
    Not completed
    3
    2
    3
    3
    3
    2
    2
         Consent withdrawn by subject
    2
    -
    2
    3
    -
    2
    2
         Investigator decision
    1
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    2
    1
    -
    3
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
    Reporting group description
    Subjects received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + placebo (NNC0480-0389)
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.

    Reporting group title
    NNC0480-0389 21.6 mg + placebo (semaglutide)
    Reporting group description
    Subjects received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.

    Reporting group values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo Total
    Number of subjects
    77 74 77 77 75 59 61 500
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    47 57 58 53 53 41 44 353
        From 65-84 years
    30 17 19 24 22 18 17 147
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    59 ± 11 57 ± 10 58 ± 10 59 ± 9 58 ± 9 57 ± 10 58 ± 9 -
    Gender Categorical
    Units: Subjects
        Female
    26 33 25 38 27 22 27 198
        Male
    51 41 52 39 48 37 34 302

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
    Reporting group description
    Subjects received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + placebo (NNC0480-0389)
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.

    Reporting group title
    NNC0480-0389 21.6 mg + placebo (semaglutide)
    Reporting group description
    Subjects received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.

    Primary: Change in HbA1c

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    End point title
    Change in HbA1c
    End point description
    Change from baseline at week 0 to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. Full Analysis Set (FAS) FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    77
    74
    77
    77
    75
    59
    61
    Units: Percentage point of HbA1c
        arithmetic mean (standard deviation)
    -2.3 ± 0.9
    -2.2 ± 0.8
    -2.2 ± 1.1
    -2.3 ± 1.0
    -2.3 ± 0.9
    -1.1 ± 1.1
    -0.4 ± 1.2
    Statistical analysis title
    2.4 mg semaglutide + 2.4 mg 0389, Placebo
    Statistical analysis description
    Hypothetical estimand
    Comparison groups
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg v Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Estimated treatment difference
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    -1.4
    Notes
    [1] - Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin’s rule to draw inference.
    Statistical analysis title
    2.4 mg semaglutide + 21.6 mg 0389 vs Placebo
    Statistical analysis description
    Hypothetical estimand
    Comparison groups
    Semaglutide 2.4 mg + NNC0480-0389 21.6 mg v Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Estimated treatment difference
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    -1.5
    Notes
    [2] - Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin’s rule to draw inference.
    Statistical analysis title
    2.4 mg semaglutide + 12.0 mg NNC0480-0389, Placebo
    Statistical analysis description
    Hypothetical estimand
    Comparison groups
    Semaglutide 2.4 mg + NNC0480-0389 12.0 mg v Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Estimated treatment difference
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    -1.5
    Notes
    [3] - Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin’s rule to draw inference.
    Statistical analysis title
    2.4 mg semaglutide + 7.2 mg NNC0480-0389, Placebo
    Statistical analysis description
    Hypothetical estimand
    Comparison groups
    Semaglutide 2.4 mg + NNC0480-0389 7.2 mg v Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Estimated treatment difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    -1.5
    Notes
    [4] - Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin’s rule to draw inference.

    Secondary: Change in body weight (kg)

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    End point title
    Change in body weight (kg)
    End point description
    Change from baseline at week 0 to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    60
    65
    65
    60
    43
    37
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    -8.9 ± 5.8
    -12 ± 7.7
    -10 ± 5.9
    -12 ± 5.4
    -9.8 ± 5.8
    -4.7 ± 5.1
    -2.6 ± 3.9
    No statistical analyses for this end point

    Secondary: Change in fasting plasma glucose

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    End point title
    Change in fasting plasma glucose
    End point description
    Change from baseline at week 0 to week 34 in Fasting Plasma Glucose (FPG) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    58
    63
    63
    59
    43
    36
    Units: millimoles per litre (mmol/L)
        arithmetic mean (standard deviation)
    -3.9 ± 2.6
    -3.4 ± 2.1
    -3.8 ± 2.4
    -3.8 ± 2.9
    -3.6 ± 1.8
    -1.4 ± 2.8
    -0.1 ± 3.2
    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 from baseline at week 0 to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    60
    65
    65
    60
    43
    37
    Units: Percentage of body weight
        arithmetic mean (standard deviation)
    -9.3 ± 5.8
    -13 ± 7.3
    -11 ± 5.8
    -13 ± 5.4
    -10 ± 6.3
    -4.3 ± 4.5
    -2.7 ± 4.1
    No statistical analyses for this end point

    Secondary: Change in waist circumference

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    End point title
    Change in waist circumference
    End point description
    Change from baseline at week 0 to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    60
    65
    65
    60
    43
    37
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    -8 ± 5
    -11 ± 7
    -9 ± 7
    -10 ± 7
    -8 ± 6
    -5 ± 5
    -3 ± 5
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure (SBP)

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    End point title
    Change in systolic blood pressure (SBP)
    End point description
    Change from baseline at week 0 to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    60
    65
    65
    60
    43
    37
    Units: Millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    -6 ± 12
    -10 ± 14
    -9 ± 13
    -13 ± 12
    -5 ± 16
    -3 ± 12
    0 ± 8
    No statistical analyses for this end point

    Secondary: Relative change in total cholesterol

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    End point title
    Relative change in total cholesterol
    End point description
    Change from baseline at week 0 to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    56
    64
    64
    59
    42
    36
    Units: Ratio of total cholesterol
        geometric mean (geometric coefficient of variation)
    0.94 ± 19.7
    0.89 ± 22.7
    0.90 ± 21.7
    0.90 ± 17.3
    0.93 ± 18.2
    1.00 ± 22.9
    0.96 ± 16.2
    No statistical analyses for this end point

    Secondary: Relative change in HDL cholesterol

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    End point title
    Relative change in HDL cholesterol
    End point description
    Change from baseline at week 0 to week 34 in High-Density Lipoprotein (HDL) cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    57
    62
    64
    59
    42
    35
    Units: Ratio of HDL cholesterol
        geometric mean (geometric coefficient of variation)
    1.05 ± 17.6
    1.06 ± 19.8
    1.07 ± 16.7
    1.00 ± 16.0
    1.04 ± 15.6
    1.04 ± 16.2
    1.04 ± 17.0
    No statistical analyses for this end point

    Secondary: Relative change in LDL cholesterol

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    End point title
    Relative change in LDL cholesterol
    End point description
    Change from baseline at week 0 to week 34 in Low-Density Lipoprotein (LDL) cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    60
    56
    61
    63
    58
    41
    34
    Units: Ratio of LDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.95 ± 28.4
    0.85 ± 46.5
    0.91 ± 37.5
    0.88 ± 36.0
    0.95 ± 32.2
    0.96 ± 53.5
    0.96 ± 29.8
    No statistical analyses for this end point

    Secondary: Relative change in VLDL cholesterol

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    End point title
    Relative change in VLDL cholesterol
    End point description
    Change from baseline at week 0 to week 34 in Very-Low-Density Lipoprotein (VLDL) cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    56
    62
    64
    59
    42
    35
    Units: Ratio of VLDL cholesterol
        geometric mean (geometric coefficient of variation)
    0.75 ± 54.0
    0.76 ± 46.4
    0.72 ± 48.9
    0.78 ± 48.2
    0.72 ± 39.9
    0.95 ± 47.9
    0.86 ± 44.5
    No statistical analyses for this end point

    Secondary: Relative change in triglycerides

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    End point title
    Relative change in triglycerides
    End point description
    Change from baseline at week 0 to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    56
    62
    64
    59
    42
    35
    Units: Ratio of triglycerides
        geometric mean (geometric coefficient of variation)
    0.75 ± 53.9
    0.76 ± 46.1
    0.72 ± 49.1
    0.78 ± 47.8
    0.72 ± 40.0
    0.96 ± 47.8
    0.86 ± 44.7
    No statistical analyses for this end point

    Secondary: Relative change in free fatty acids

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    End point title
    Relative change in free fatty acids
    End point description
    Change in baseline at week 0 to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    57
    64
    65
    58
    43
    35
    Units: Ratio of free fatty acids
        geometric mean (geometric coefficient of variation)
    0.85 ± 76.1
    0.74 ± 66.0
    0.77 ± 43.5
    0.75 ± 64.9
    0.88 ± 42.3
    0.96 ± 51.1
    0.91 ± 47.3
    No statistical analyses for this end point

    Secondary: Relative change in Apolipoprotein B

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    End point title
    Relative change in Apolipoprotein B
    End point description
    Change from baseline at week 0 to week 34 in Apolipoprotein B (Apo B) measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    60
    58
    65
    65
    59
    43
    36
    Units: Ratio of ApoB
        geometric mean (geometric coefficient of variation)
    0.90 ± 22.8
    0.84 ± 25.7
    0.85 ± 23.5
    0.85 ± 22.1
    0.91 ± 18.4
    1.00 ± 28.2
    0.94 ± 14.7
    No statistical analyses for this end point

    Secondary: Relative change in high sensitivity C-Reactive Protein (hsCRP)

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    End point title
    Relative change in high sensitivity C-Reactive Protein (hsCRP)
    End point description
    Change from baseline at week 0 to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which subjects are considered exposed to randomised treatment and have not initiated any rescue medication. FAS which comprised all randomised subjects. Number of subjects analyzed = Number of subjects contributing to the analysis.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 24 (week 34)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    61
    57
    64
    65
    59
    43
    35
    Units: Ratio of hsCRP
        geometric mean (geometric coefficient of variation)
    0.56 ± 107.0
    0.54 ± 136.9
    0.64 ± 147.9
    0.66 ± 135.5
    0.61 ± 141.5
    0.82 ± 89.7
    0.93 ± 201.6
    No statistical analyses for this end point

    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
    An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment. Safety Analysis Set (SAS) included all participants exposed to randomised treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to visit 25 (week 39)
    End point values
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Number of subjects analysed
    77
    74
    77
    77
    75
    59
    61
    Units: Events
        number (not applicable)
    229
    304
    206
    308
    271
    240
    95
    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 visit 25 (week 39)
    Adverse event reporting additional description
    All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all subjects exposed to randomised treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
    Reporting group description
    Subjects received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Subjects received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).

    Reporting group title
    Semaglutide 2.4 mg + placebo (NNC0480-0389)
    Reporting group description
    Subjects received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.

    Reporting group title
    NNC0480-0389 21.6 mg + placebo (semaglutide)
    Reporting group description
    Subjects received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.

    Serious adverse events
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 77 (7.79%)
    3 / 74 (4.05%)
    2 / 77 (2.60%)
    5 / 77 (6.49%)
    3 / 75 (4.00%)
    2 / 59 (3.39%)
    2 / 61 (3.28%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 77 (2.60%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Giant cell arteritis
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    1 / 75 (1.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Parathyroid cyst
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Semaglutide 2.4 mg + NNC0480-0389 2.4 mg Semaglutide 2.4 mg + NNC0480-0389 7.2 mg Semaglutide 2.4 mg + NNC0480-0389 12.0 mg Semaglutide 2.4 mg + NNC0480-0389 21.6 mg Semaglutide 2.4 mg + placebo (NNC0480-0389) NNC0480-0389 21.6 mg + placebo (semaglutide) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 77 (51.95%)
    44 / 74 (59.46%)
    36 / 77 (46.75%)
    37 / 77 (48.05%)
    34 / 75 (45.33%)
    25 / 59 (42.37%)
    23 / 61 (37.70%)
    Investigations
    Amylase increased
         subjects affected / exposed
    3 / 77 (3.90%)
    3 / 74 (4.05%)
    0 / 77 (0.00%)
    5 / 77 (6.49%)
    1 / 75 (1.33%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences all number
    3
    4
    0
    5
    1
    1
    0
    Lipase increased
         subjects affected / exposed
    4 / 77 (5.19%)
    9 / 74 (12.16%)
    2 / 77 (2.60%)
    7 / 77 (9.09%)
    2 / 75 (2.67%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
         occurrences all number
    4
    10
    2
    8
    2
    1
    2
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 77 (2.60%)
    4 / 74 (5.41%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
    1 / 75 (1.33%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences all number
    2
    5
    0
    2
    1
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 77 (5.19%)
    3 / 74 (4.05%)
    4 / 77 (5.19%)
    3 / 77 (3.90%)
    5 / 75 (6.67%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    4
    3
    4
    4
    6
    0
    1
    Headache
         subjects affected / exposed
    6 / 77 (7.79%)
    3 / 74 (4.05%)
    5 / 77 (6.49%)
    3 / 77 (3.90%)
    7 / 75 (9.33%)
    5 / 59 (8.47%)
    2 / 61 (3.28%)
         occurrences all number
    9
    3
    7
    6
    16
    12
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 74 (1.35%)
    2 / 77 (2.60%)
    4 / 77 (5.19%)
    2 / 75 (2.67%)
    2 / 59 (3.39%)
    0 / 61 (0.00%)
         occurrences all number
    1
    1
    3
    7
    2
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 74 (1.35%)
    3 / 77 (3.90%)
    2 / 77 (2.60%)
    4 / 75 (5.33%)
    2 / 59 (3.39%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    3
    2
    9
    3
    1
    Injection site pruritus
         subjects affected / exposed
    1 / 77 (1.30%)
    1 / 74 (1.35%)
    0 / 77 (0.00%)
    5 / 77 (6.49%)
    0 / 75 (0.00%)
    5 / 59 (8.47%)
    0 / 61 (0.00%)
         occurrences all number
    1
    2
    0
    38
    0
    61
    0
    Injection site erythema
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    4 / 77 (5.19%)
    6 / 77 (7.79%)
    0 / 75 (0.00%)
    6 / 59 (10.17%)
    0 / 61 (0.00%)
         occurrences all number
    0
    1
    10
    25
    0
    23
    0
    Injection site reaction
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 74 (2.70%)
    2 / 77 (2.60%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    6 / 59 (10.17%)
    0 / 61 (0.00%)
         occurrences all number
    1
    3
    4
    3
    0
    13
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    4 / 77 (5.19%)
    3 / 74 (4.05%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
    4 / 75 (5.33%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences all number
    4
    4
    2
    2
    6
    2
    0
    Eructation
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 74 (2.70%)
    1 / 77 (1.30%)
    2 / 77 (2.60%)
    5 / 75 (6.67%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    5
    2
    4
    6
    0
    1
    Diarrhoea
         subjects affected / exposed
    11 / 77 (14.29%)
    16 / 74 (21.62%)
    11 / 77 (14.29%)
    10 / 77 (12.99%)
    14 / 75 (18.67%)
    5 / 59 (8.47%)
    7 / 61 (11.48%)
         occurrences all number
    25
    30
    22
    18
    21
    12
    9
    Constipation
         subjects affected / exposed
    4 / 77 (5.19%)
    6 / 74 (8.11%)
    7 / 77 (9.09%)
    6 / 77 (7.79%)
    4 / 75 (5.33%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    4
    7
    7
    6
    6
    3
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 77 (1.30%)
    2 / 74 (2.70%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
    5 / 75 (6.67%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    2
    2
    2
    6
    0
    1
    Nausea
         subjects affected / exposed
    15 / 77 (19.48%)
    9 / 74 (12.16%)
    5 / 77 (6.49%)
    10 / 77 (12.99%)
    17 / 75 (22.67%)
    4 / 59 (6.78%)
    1 / 61 (1.64%)
         occurrences all number
    21
    25
    8
    13
    29
    8
    2
    Vomiting
         subjects affected / exposed
    4 / 77 (5.19%)
    7 / 74 (9.46%)
    4 / 77 (5.19%)
    5 / 77 (6.49%)
    10 / 75 (13.33%)
    2 / 59 (3.39%)
    1 / 61 (1.64%)
         occurrences all number
    4
    9
    4
    7
    12
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 77 (2.60%)
    5 / 74 (6.76%)
    3 / 77 (3.90%)
    2 / 77 (2.60%)
    1 / 75 (1.33%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
         occurrences all number
    2
    5
    3
    2
    1
    1
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 77 (7.79%)
    4 / 74 (5.41%)
    6 / 77 (7.79%)
    9 / 77 (11.69%)
    7 / 75 (9.33%)
    2 / 59 (3.39%)
    8 / 61 (13.11%)
         occurrences all number
    7
    4
    6
    9
    7
    2
    8
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 74 (2.70%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
    2 / 75 (2.67%)
    4 / 59 (6.78%)
    1 / 61 (1.64%)
         occurrences all number
    0
    2
    2
    2
    2
    4
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 77 (3.90%)
    4 / 74 (5.41%)
    4 / 77 (5.19%)
    2 / 77 (2.60%)
    3 / 75 (4.00%)
    2 / 59 (3.39%)
    2 / 61 (3.28%)
         occurrences all number
    4
    4
    4
    2
    3
    2
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 77 (5.19%)
    8 / 74 (10.81%)
    3 / 77 (3.90%)
    7 / 77 (9.09%)
    8 / 75 (10.67%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    4
    8
    4
    7
    8
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    2 / 77 (2.60%)
    1 / 77 (1.30%)
    0 / 75 (0.00%)
    2 / 59 (3.39%)
    6 / 61 (9.84%)
         occurrences all number
    1
    0
    2
    1
    0
    2
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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