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    Clinical Trial Results:
    A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension

    Summary
    EudraCT number
    		 2021-005738-41
    Trial protocol
    		 ES   FR   CZ   SK   IT   NL   DE   BG  
    Global end of trial date
    27 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Sep 2025
    First version publication date
    11 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CXXB750B12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05562934
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Lichtstrasse 35, Basel, Switzerland, 4056
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    27 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and dose-response relationship of XXB750 30 mg subcutaneous (SC) every four weeks (q4w), 60 mg SC q4w, 120 mg SC q4w, and 240 mg SC q4w compared to placebo in reducing the mean 24 hours ambulatory systolic blood pressure (mean 24hr SBP) from baseline to Week 12.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 56
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Taiwan: 11
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Bulgaria: 14
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    China: 11
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Czechia: 3
    Worldwide total number of subjects
    189
    EEA total number of subjects
    81
    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)
    112
    From 65 to 84 years
    75
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 135 investigative sites in 16 countries.

    Pre-assignment
    Screening details
    		 The study consisted of a screening period of approximately 7 days.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.
    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
    Placebo subcutaneous every 4 weeks, total of 3 doses.

    Arm title
    		 XXB750 30 mg
    Arm description
    		 XXB750 30 mg s.c every 4 weeks, total of 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XXB750
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XXB750 30 mg subcutaneous every 4 weeks, total of 3 doses.

    Arm title
    		 XXB750 60 mg
    Arm description
    		 XXB750 60 mg s.c every 4 weeks, total of 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XXB750
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XXB750 60 mg subcutaneous every 4 weeks, total of 3 doses.

    Arm title
    		 XXB750 120 mg
    Arm description
    		 XXB750 120 mg s.c every 4 weeks, total of 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XXB750
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XXB750 120 mg subcutaneous every 4 weeks, total of 3 doses.

    Arm title
    		 XXB750 120 mg/240 mg
    Arm description
    		 XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    XXB750
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    XXB750 120 mg subcutaneous (s.c.) at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.

    Number of subjects in period 1
    		Placebo XXB750 30 mg XXB750 60 mg XXB750 120 mg XXB750 120 mg/240 mg
    Started
    42
    32
    36
    37
    42
    Completed
    42
    30
    35
    35
    38
    Not completed
    0
    2
    1
    2
    4
         Consent withdrawn by subject
    -
    -
    1
    1
    -
         Adverse events
    -
    2
    -
    -
    2
         Lost to follow-up
    -
    -
    -
    -
    1
         Protocol deviation
    -
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 30 mg
    Reporting group description
    		 XXB750 30 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 60 mg
    Reporting group description
    		 XXB750 60 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 120 mg
    Reporting group description
    		 XXB750 120 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 120 mg/240 mg
    Reporting group description
    		 XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.

    Reporting group values
    		 Placebo XXB750 30 mg XXB750 60 mg XXB750 120 mg XXB750 120 mg/240 mg Total
    Number of subjects
    		 42 32 36 37 42 189
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 26 23 18 18 27 112
        From 65-84 years
    		 16 8 18 19 14 75
        85 years and over
    		 0 1 0 0 1 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.14 ( 10.862 ) 58.53 ( 11.565 ) 63.44 ( 10.191 ) 62.41 ( 11.642 ) 60.64 ( 10.085 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 13 8 6 18 13 58
        Male
    		 29 24 30 19 29 131
    Race/Ethnicity, Customized
    Units: Subjects
        Black Or African American
    		 6 7 4 4 6 27
        White
    		 27 16 24 24 25 116
        Asian
    		 8 5 6 8 10 37
        Other
    		 1 4 2 1 1 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 30 mg
    Reporting group description
    		 XXB750 30 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 60 mg
    Reporting group description
    		 XXB750 60 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 120 mg
    Reporting group description
    		 XXB750 120 mg s.c every 4 weeks, total of 3 doses.

    Reporting group title
    XXB750 120 mg/240 mg
    Reporting group description
    		 XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.

    Primary: Dose-response (DR) relationship of XXB750 with respect to change from baseline in Systolic Blood Pressure (SBP) 24 hours

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    End point title
    		 Dose-response (DR) relationship of XXB750 with respect to change from baseline in Systolic Blood Pressure (SBP) 24 hours
    End point description
    To evaluate the efficacy and dose-response relationship of different doses of XXB750 compared to placebo in reducing the mean 24 hours ambulatory systolic blood pressure from baseline at Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. The primary outcome measure was evaluated using an optimally weighted contrast test following the Multiple Comparison Procedure-Modeling (MCP-MOD) methodology. There were five candidate models to capture the shape of the dose-response relationship for XXB750 at Week 12 endpoint. The outcome for the single best candidate model is shown in the Statistical Analysis section.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo XXB750 30 mg XXB750 60 mg XXB750 120 mg XXB750 120 mg/240 mg
    Number of subjects analysed
    40
    25
    30
    32
    36
    Units: mmHg
        least squares mean (confidence interval 95%)
    -5.77 (-10.74 to -1.12)
    -6.41 (-10.15 to -2.85)
    -6.63 (-10.40 to -3.53)
    -6.66 (-12.57 to -3.16)
    -5.40 (-9.58 to -0.36)
    Statistical analysis title
    		 SBP
    Comparison groups
    Placebo v XXB750 30 mg v XXB750 60 mg v XXB750 120 mg v XXB750 120 mg/240 mg
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5651 [1]
    Method
    		 Multiple Comparisons Procedure-MOD
    Confidence interval
    Notes
    [1] - Single best candidate model is the one with the lowest adjusted p-value of the 5 candidate models

    Secondary: Change from baseline in SBP 24 hours at Week 12 (difference between highest XXB750 dose and placebo)

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    End point title
    		 Change from baseline in SBP 24 hours at Week 12 (difference between highest XXB750 dose and placebo) [2]
    End point description
    To evaluate the treatment effect of the highest XXB750 dose versus placebo in reducing the mean 24 hours SBP from baseline to Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    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 end point is specific for the arms presented.
    End point values
    		 Placebo XXB750 120 mg/240 mg
    Number of subjects analysed
    40
    36
    Units: mmHg
        least squares mean (standard error)
    -6.01 ( 2.42 )
    -4.64 ( 2.49 )
    Statistical analysis title
    		 SBP
    Comparison groups
    Placebo v XXB750 120 mg/240 mg
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6955
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.48
         upper limit
    		 8.21

    Secondary: Change from baseline in SBP 24 hours of average of Week 9 and Week 12 (difference between highest XXB750 dose and placebo)

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    End point title
    		 Change from baseline in SBP 24 hours of average of Week 9 and Week 12 (difference between highest XXB750 dose and placebo) [3]
    End point description
    To evaluate the treatment effect of the highest XXB750 dose versus placebo in the dosing interval average of ambulatory SBP as assessed by average of mean 24 hours SBP measured at week 9 and week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9 and Week 12
    Notes
    [3] - 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 end point is specific for the arms presented.
    End point values
    		 Placebo XXB750 120 mg/240 mg
    Number of subjects analysed
    40
    38
    Units: mmHg
        least squares mean (standard error)
    -5.77 ( 2.13 )
    -4.62 ( 2.21 )
    Statistical analysis title
    		 SBP
    Comparison groups
    Placebo v XXB750 120 mg/240 mg
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7108
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 7.18

    Secondary: The proportion of participants achieving blood pressure (BP) control

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    End point title
    		 The proportion of participants achieving blood pressure (BP) control
    End point description
    To evaluate the proportions of participants achieving ambulatory BP control defined as mean 24 hours SBP <130 mmHg and mean 24 hours DBP < 80 mmHg with respect to the dose-response relationship of the four XXB750 dose level groups compared to placebo at week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo XXB750 30 mg XXB750 60 mg XXB750 120 mg XXB750 120 mg/240 mg
    Number of subjects analysed
    40
    25
    30
    32
    36
    Units: percentage
        number (not applicable)
    13.2
    15.0
    17.7
    22.0
    25.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    XXB750 30 mg
    Reporting group description
    		 XXB750 30 mg

    Reporting group title
    XXB750 240 mg
    Reporting group description
    		 XXB750 240 mg

    Reporting group title
    XXB750 120 mg
    Reporting group description
    		 XXB750 120 mg

    Reporting group title
    XXB750 60 mg
    Reporting group description
    		 XXB750 60 mg

    Serious adverse events
    		 Placebo XXB750 30 mg XXB750 240 mg XXB750 120 mg XXB750 60 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 32 (6.25%)
    3 / 42 (7.14%)
    1 / 37 (2.70%)
    3 / 36 (8.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    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
    Coronary artery disease
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Dizziness
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Exertional rhabdomyolysis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    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
    Infectious pleural effusion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Osteomyelitis acute
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    3 / 42 (7.14%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Hypokalaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo XXB750 30 mg XXB750 240 mg XXB750 120 mg XXB750 60 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 42 (64.29%)
    19 / 32 (59.38%)
    18 / 42 (42.86%)
    16 / 37 (43.24%)
    18 / 36 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Glomus tumour
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vascular disorders
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    1 / 37 (2.70%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    1
    1
    1
    Hypertension
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    0
    2
    Phlebitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    2 / 37 (5.41%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    1
    2
    4
    Pyrexia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    1
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    3 / 37 (8.11%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    3
    0
    Bronchopneumopathy
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Irritability
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Amylase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 32 (6.25%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Blood iron abnormal
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Glucose urine present
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    Electrocardiogram ST-T segment elevation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Electrocardiogram PR prolongation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Haematocrit increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Heart rate abnormal
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Heart sounds abnormal
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Protein urine present
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    2 / 42 (4.76%)
    1 / 37 (2.70%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    1
    1
    Transaminases increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Burns first degree
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ankle fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vaccination complication
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 32 (6.25%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Angina pectoris
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Diastolic dysfunction
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Cervical radiculopathy
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 32 (9.38%)
    2 / 42 (4.76%)
    1 / 37 (2.70%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    2
    0
    2
    Headache
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 32 (6.25%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Vertebral artery occlusion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 32 (3.13%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    1
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Miliaria
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin swelling
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Solar urticaria
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Azotaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Albuminuria
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Renal cyst
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    2 / 37 (5.41%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 32 (6.25%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    1
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 32 (3.13%)
    3 / 42 (7.14%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Carbuncle
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infected bite
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site cellulitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    1 / 37 (2.70%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    0
    1
    1
    Pneumonia aspiration
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    2 / 37 (5.41%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    Wound infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 32 (3.13%)
    1 / 42 (2.38%)
    4 / 37 (10.81%)
    0 / 36 (0.00%)
         occurrences all number
    2
    1
    1
    4
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    1
    Impaired fasting glucose
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    3 / 37 (8.11%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    0
    1
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    2 / 42 (4.76%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 32 (3.13%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 32 (3.13%)
    1 / 42 (2.38%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    1 / 42 (2.38%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 32 (0.00%)
    0 / 42 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2023
    This amendment was generated to update some of the inclusion/exclusion criteria.
    05 Mar 2024
    This amendment was generated: • To clarify the treatment unblinding during primary endpoint and safety analysis when all participants have completed week 12 or discontinued from the study. • Stage 2 of the study was eliminated as the primary purpose of this study was to evaluate the dose response of different doses of XXB750 vs. placebo. • Updated model averaging method in using bootstrapping samples.

    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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