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    Clinical Trial Results:
    A Randomized, Parallel, Double-blind, Placebo-controlled, Dose-ranging, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD8233 Treatment in Participants With Dyslipidemia

    Summary
    EudraCT number
    		 2020-000767-23
    Trial protocol
    		 SK   DK  
    Global end of trial date
    20 Jul 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Mar 2023
    First version publication date
    03 Aug 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Aligning with CTGOV posting.

    Trial information

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    Trial identification
    Sponsor protocol code
    D7990C00003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Astraalléen, Södertälje, Sweden,
    Public contact
    Information Center, AstraZeneca, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.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
    26 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of AZD8233 on level of dyslipidemia related biomarker (LDL-C) across different dose levels (absolute change from baseline in log transformed LDL-C in plasma).
    Protection of trial subjects
    This study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2020
    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
    United States: 50
    Country: Number of subjects enrolled
    Denmark: 25
    Country: Number of subjects enrolled
    Slovakia: 44
    Worldwide total number of subjects
    119
    EEA total number of subjects
    69
    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)
    72
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 19 clinical research center in Denmark, Slovakia and the USA. First subject enrolled (First subject first visit/first consent signed date): 28 October 2020. Last subject last visit: 20 July 2021.

    Pre-assignment
    Screening details
    		 Following a screening period of up to 42 days, eligible participants received an SC injection of study intervention on Days 1, 8, 29, and 57.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD8233 low dose
    Arm description
    		 AZD8233 low dose for subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD8233 low dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on Days 1, 8, 29, and 57

    Arm title
    		 AZD8233 medium dose
    Arm description
    		 AZD8233 medium dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD8233 medium dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on Days 1, 8, 29, and 57.

    Arm title
    		 AZD8233 high dose
    Arm description
    		 AZD8233 high dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD8233 high dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on Days 1, 8, 29, and 57.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on Days 1, 8, 29, and 57

    Number of subjects in period 1
    		AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Started
    30
    30
    29
    30
    Completed
    28
    29
    27
    30
    Not completed
    2
    1
    2
    0
         Consent withdrawn by subject
    1
    -
    -
    -
         Reason not given
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    2
    -
         Lost to follow-up
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD8233 low dose
    Reporting group description
    		 AZD8233 low dose for subcutaneous injection.

    Reporting group title
    AZD8233 medium dose
    Reporting group description
    		 AZD8233 medium dose

    Reporting group title
    AZD8233 high dose
    Reporting group description
    		 AZD8233 high dose

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo Total
    Number of subjects
    		 30 30 29 30 119
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 18 20 18 16 72
        From 65-84 years
    		 12 10 11 14 47
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 61.8 ± 7.1 60.6 ± 7.4 60.4 ± 8.4 63.9 ± 7.3 -
    Sex: Female, Male
    Units: Participants
        Female
    		 16 12 11 18 57
        Male
    		 14 18 18 12 62
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 0 0 0 0 0
        ASIAN
    		 1 0 0 0 1
        BLACK OR AFRICAN AMERICAN
    		 2 2 1 3 8
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    		 0 0 0 0 0
        WHITE
    		 27 28 28 27 110

    End points

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    End points reporting groups
    Reporting group title
    AZD8233 low dose
    Reporting group description
    		 AZD8233 low dose for subcutaneous injection.

    Reporting group title
    AZD8233 medium dose
    Reporting group description
    		 AZD8233 medium dose

    Reporting group title
    AZD8233 high dose
    Reporting group description
    		 AZD8233 high dose

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Change in LDL-C at week 12.

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    End point title
    		 Change in LDL-C at week 12. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No plasma concentrations were measured in placebo arm.
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: Ratio
        geometric mean (confidence interval 95%)
    0.606 (0.517 to 0.710)
    0.270 (0.230 to 0.317)
    0.206 (0.174 to 0.242)
    0.978 (0.834 to 1.147)
    No statistical analyses for this end point

    Secondary: Relative change from baseline in PCSK9 concentration in plasma at week 12.

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    End point title
    		 Relative change from baseline in PCSK9 concentration in plasma at week 12.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: Ratio
        geometric mean (confidence interval 95%)
    0.420 (0.340 to 0.520)
    0.110 (0.090 to 0.140)
    0.060 (0.050 to 0.080)
    0.950 (0.770 to 1.180)
    No statistical analyses for this end point

    Secondary: Percentage change from baseline in concentration of TC, HDL-C, Non-HDL-C, VLDL-C, ApoA1, ApoB, Lp(a), Triglycerides, Remnants cholesterol

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    End point title
    		 Percentage change from baseline in concentration of TC, HDL-C, Non-HDL-C, VLDL-C, ApoA1, ApoB, Lp(a), Triglycerides, Remnants cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: Percent
    least squares mean (confidence interval 95%)
        Triglycerides
    -7.70 (-18.44 to 3.05)
    -12.95 (-23.77 to -2.12)
    -12.70 (-23.88 to -1.52)
    2.69 (-8.19 to 13.56)
        Total cholesterol
    -21.13 (-26.56 to -15.70)
    -43.90 (-49.43 to -38.37)
    -47.58 (-53.37 to -41.78)
    -1.11 (-6.56 to 4.35)
        HDL-C
    3.37 (-1.12 to 7.86)
    6.50 (1.96 to 11.04)
    5.57 (0.90 to 10.25)
    1.34 (-3.28 to 5.97)
        Non-HDL-C
    -29.57 (-36.58 to -22.56)
    -61.25 (-68.38 to -54.11)
    -67.92 (-75.38 to -60.45)
    -0.65 (-7.81 to 6.51)
        VLDL-C
    -7.54 (-18.36 to 3.27)
    -12.09 (-23.04 to -1.15)
    -11.13 (-22.59 to 0.33)
    3.22 (-7.90 to 14.35)
        ApoB
    -29.50 (-35.64 to -23.35)
    -60.13 (-66.33 to -53.93)
    -67.07 (-73.46 to -60.68)
    -1.65 (-7.83 to 4.53)
        Remnants cholesterol
    -13.50 (-39.57 to 12.56)
    -16.54 (-42.97 to 9.88)
    -26.84 (-54.23 to 0.54)
    6.38 (-20.28 to 33.05)
    No statistical analyses for this end point

    Secondary: Plasma concentration of AZD8233

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    End point title
    		 Plasma concentration of AZD8233 [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Measurement at week 1, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24 after first dose administration.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary analysis is presented in this table.
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose
    Number of subjects analysed
    30
    30
    29
    Units: ug/L
    arithmetic mean (standard deviation)
        Week 1
    0.346 ± 0.59
    0.681 ± 0.24
    1.201 ± 0.49
        Week 4
    0.238 ± 0.21
    0.699 ± 0.33
    1.366 ± 0.71
        Week 6
    0.288 ± 0.21
    0.870 ± 0.34
    1.917 ± 1.09
        Week 8
    0.152 ± 0.10
    0.628 ± 0.57
    1.000 ± 0.68
        Week 10
    0.241 ± 0.15
    0.751 ± 0.29
    1.562 ± 0.84
        Week 12
    0.134 ± 0.07
    0.476 ± 0.23
    0.976 ± 0.75
        Week 16
    0.087 ± 0.09
    0.297 ± 0.53
    0.507 ± 0.70
        Week 20
    0.053 ± 0.004
    0.153 ± 0.26
    0.376 ± 0.68
        Week 24
    0.111 ± 0.31
    0.111 ± 0.15
    0.350 ± 0.62
    No statistical analyses for this end point

    Secondary: Anti-drug antibodies (ADAs) during the treatment period and follow-up period

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    End point title
    		 Anti-drug antibodies (ADAs) during the treatment period and follow-up period
    End point description
    ADA titre results for subjects with positive ADA.
    End point type
    Secondary
    End point timeframe
    Measurement at week 0, week 1, week 4, week 8, week 12, week 16, week 20, week 24
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: ADA titre
    median (full range (min-max))
        Baseline
    100 (100 to 100)
    200 (200 to 200)
    0 (0 to 0)
    100 (100 to 100)
        Week 1
    100 (50 to 800)
    200 (200 to 200)
    0 (0 to 0)
    100 (100 to 100)
        Week 4
    150 (100 to 1600)
    200 (100 to 400)
    75 (50 to 100)
    100 (100 to 100)
        Week 8
    400 (200 to 3200)
    200 (100 to 400)
    75 (50 to 100)
    100 (100 to 100)
        Week 12
    200 (200 to 1600)
    200 (100 to 400)
    200 (200 to 200)
    50 (50 to 50)
        Week 16
    400 (100 to 1600)
    200 (50 to 400)
    300 (200 to 400)
    100 (100 to 100)
        Week 20
    400 (200 to 1600)
    200 (100 to 400)
    500 (200 to 800)
    100 (100 to 100)
        Week 24
    400 (200 to 800)
    300 (100 to 400)
    200 (50 to 800)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: Percentage change from baseline in levels of LDL-C in plasma

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    End point title
    		 Percentage change from baseline in levels of LDL-C in plasma
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: Percent
        least squares mean (confidence interval 95%)
    -32.22 (-39.79 to -24.66)
    -69.26 (-76.89 to -61.63)
    -76.50 (-84.37 to -68.63)
    -1.53 (-9.14 to 6.09)
    No statistical analyses for this end point

    Secondary: Percentage change from baseline to week 12 in Lp(a)

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    End point title
    		 Percentage change from baseline to week 12 in Lp(a)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    26
    28
    26
    24
    Units: Percent
        median (full range (min-max))
    -6.94 (-68.0 to 15.2)
    -38.89 (-88.2 to 0.0)
    -44.66 (-84.1 to 0.0)
    0.0 (-43.3 to 50.7)
    No statistical analyses for this end point

    Other pre-specified: Number of subjects with an ECG determined to be abnormal and clinically significant

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    End point title
    		 Number of subjects with an ECG determined to be abnormal and clinically significant
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline to end of treatment
    End point values
    		 AZD8233 low dose AZD8233 medium dose AZD8233 high dose Placebo
    Number of subjects analysed
    30
    30
    29
    30
    Units: Number of subjects
        Baseline
    0
    0
    0
    0
        End of treatment
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    AZD8233 (50 mg)
    Reporting group description
    		 -

    Reporting group title
    AZD8233 (15 mg)
    Reporting group description
    		 -

    Reporting group title
    AZD8233 (90 mg)
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo AZD8233 (50 mg) AZD8233 (15 mg) AZD8233 (90 mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo AZD8233 (50 mg) AZD8233 (15 mg) AZD8233 (90 mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 30 (40.00%)
    17 / 30 (56.67%)
    14 / 30 (46.67%)
    20 / 29 (68.97%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    1
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    2
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injection site reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Injection site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    1
    2
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ovarian mass
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pelvic pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Lipids increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Protein urine present
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Head injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Radius fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    2
    Skin abrasion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Tooth fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    2
    0
    2
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Radiculopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Spinal cord compression
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Anaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Spontaneous haematoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Ear disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    0
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    3
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Back pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sacroiliitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wrist deformity
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal vestibulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    2
    1
    COVID-19
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    1
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2020
    •Clarifications made to study visit/assessment timings and procedures in relation to screening, pre-dose assessments, home visits, and coagulation parameters • Minor clarifications made in inclusion criterion #7(b) and exclusion criteria #12 and #29 • Clarification that participants must not make changes to or take new concomitant medications without Investigator consultation • Discontinuation of study intervention criteria in relation to ALT/AST parameters expanded

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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