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    Clinical Trial Results:
    A Randomized, Patient and Investigator Blinded, Placebo Controlled, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With Non-alcoholic Steatohepatitis (NASH)

    Summary
    EudraCT number
    		 2016-002833-31
    Trial protocol
    		 GB  
    Global end of trial date
    04 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Oct 2019
    First version publication date
    09 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLMB763X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02913105
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    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
    04 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    - To determine the safety and tolerability of LMB763 during 12 weeks of treatment - To determine the effect of LMB763 on circulating alanine aminotransferase (ALT) levels
    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
    24 Oct 2016
    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
    Australia: 3
    Country: Number of subjects enrolled
    Jordan: 15
    Country: Number of subjects enrolled
    New Zealand: 21
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United States: 72
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    121
    EEA total number of subjects
    3
    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)
    110
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 25 centres across 6 countries.

    Pre-assignment
    Screening details
    		 A total of 121 subjects were enrolled in the study, and included in the safety population. Placebo data have been pooled from placebo treated subjects from both cohorts (100 mg and 50 mg matching placebo).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LMB763 100 mg
    Arm description
    		 LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LMB763 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Arm title
    		 LMB763 50 mg
    Arm description
    		 LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LMB763 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Arm title
    		 Pooled Placebo
    Arm description
    		 LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Pooled Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours)

    Number of subjects in period 1
    		LMB763 100 mg LMB763 50 mg Pooled Placebo
    Started
    37
    44
    40
    Completed
    22
    39
    33
    Not completed
    15
    5
    7
         Physician decision
    1
    1
    -
         Adverse event, non-fatal
    11
    -
    4
         Reason Not Specified
    3
    1
    1
         Non-Compliance With Study Drug
    -
    -
    1
         Withdrawal by Subject
    -
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LMB763 100 mg
    Reporting group description
    		 LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Reporting group title
    LMB763 50 mg
    Reporting group description
    		 LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Reporting group values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo Total
    Number of subjects
    		 37 44 40 121
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 30 44 36 110
        From 65-84 years
    		 7 0 4 11
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.3 ± 15.55 49.5 ± 8.45 51.6 ± 11.65 -
    Gender categorical
    Units: Subjects
        Female
    		 22 23 24 69
        Male
    		 15 21 16 52

    End points

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    End points reporting groups
    Reporting group title
    LMB763 100 mg
    Reporting group description
    		 LMB763 100 mg capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Reporting group title
    LMB763 50 mg
    Reporting group description
    		 LMB763 50 mg (2 x 25 mg) capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 LMB763 100 mg or 50 mg matching placebo capsules, orally, once daily for 12 weeks (84 days) under fasted conditions (no food or drink for at least 6 hours).

    Subject analysis set title
    LMB763 100 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pharmacokinetic (PK) analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data.

    Subject analysis set title
    LMB763 50 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. Safety analysis set included all subjects that received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From date of first subject first treatment until Last Patient Last Visit (LPLV) (up to Day 112 (End of Study (EOS))
    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 statistical analysis was planned for this end point
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [2]
    44 [3]
    40 [4]
    Units: subjects
        AEs
    35
    37
    33
        SAEs
    2
    3
    0
    Notes
    [2] - Safety analysis set.
    [3] - Safety analysis set.
    [4] - Safety analysis set.
    No statistical analyses for this end point

    Primary: Change From Baseline in Alanine Aminotransferase (ALT) Levels

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    End point title
    		 Change From Baseline in Alanine Aminotransferase (ALT) Levels
    End point description
    ALT level assessment was one of the diagnostic parameters in Liver function test (LFT). Baseline was defined as the mean of ALT levels at baseline and pre-dose visits. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). Pharmacodynamic (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Primary
    End point timeframe
    Baseline to Day 84 (Week 12)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [5]
    44 [6]
    40 [7]
    Units: units per litre (U/L)
    geometric mean (geometric coefficient of variation)
        Baseline for Day 84 Analysis
    67.215 ± 30.8
    48.114 ± 42.2
    59.544 ± 39.5
        Change from Baseline at Day 84
    0.667 ± 33.8
    0.702 ± 41.1
    0.901 ± 25.5
    Notes
    [5] - PD analysis set: n = 24, 24
    [6] - PD analysis set: n = 40, 40
    [7] - PD analysis set: n = 33, 33
    Statistical analysis title
    		 LMB763 100 mg, LMB763 50 mg
    Comparison groups
    LMB763 100 mg v LMB763 50 mg
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.7489 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Geometric Mean Ratios
    Point estimate
    0.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.13
    Notes
    [8] - Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
    [9] - An unstructured variance-covariance structure was used.
    Statistical analysis title
    		 LMB763 100 mg, Pooled Placebo
    Comparison groups
    LMB763 100 mg v Pooled Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.0005 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Geometric Mean Ratios
    Point estimate
    0.72
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.84
    Notes
    [10] - Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
    [11] - An unstructured variance-covariance structure was used.
    Statistical analysis title
    		 LMB763 50 mg, Pooled Placebo
    Comparison groups
    LMB763 50 mg v Pooled Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.0005 [13]
    Method
    		 ANCOVA
    Parameter type
    		 Geometric Mean Ratios
    Point estimate
    0.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.85
    Notes
    [12] - Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).
    [13] - An unstructured variance-covariance structure was used.

    Secondary: Observed Maximum Plasma Concentration (Cmax) of LMB763

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    End point title
    		 Observed Maximum Plasma Concentration (Cmax) of LMB763
    End point description
    PK analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Days 1 and 42
    End point values
    		 LMB763 100 mg LMB763 50 mg
    Number of subjects analysed
    37 [14]
    43 [15]
    Units: nanograms per millilitre (ng/mL)
    arithmetic mean (standard deviation)
        Day 1
    3080 ± 1360
    1290 ± 620
        Day 42
    2230 ± 1190
    1290 ± 690
    Notes
    [14] - PK analysis set: n = 37, 23
    [15] - PK analysis set: n = 43, 42
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Concentration (Tmax) of LMB763

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    End point title
    		 Time to Reach Maximum Concentration (Tmax) of LMB763
    End point description
    PK analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Days 1 and 42
    End point values
    		 LMB763 100 mg LMB763 50 mg
    Number of subjects analysed
    37 [16]
    43 [17]
    Units: hour (h)
    median (full range (min-max))
        Day 1
    2.00 (1.00 to 6.00)
    2.00 (1.00 to 6.08)
        Day 42
    2.03 (1.00 to 6.03)
    2.02 (1.00 to 6.00)
    Notes
    [16] - Pk analysis set: n = 37, 24
    [17] - Pk analysis set: n = 43, 42
    No statistical analyses for this end point

    Secondary: Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763

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    End point title
    		 Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763
    End point description
    PK analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Days 1 and 42
    End point values
    		 LMB763 100 mg LMB763 50 mg
    Number of subjects analysed
    37 [18]
    43 [19]
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Day 1
    11200 ± 4740
    4360 ± 2350
        Day 42
    8570 ± 4120
    5180 ± 2870
    Notes
    [18] - Pk analysis set: n = 37, 23
    [19] - Pk analysis set: n = 42, 42
    No statistical analyses for this end point

    Secondary: Accumulation Ratio (Racc) of LMB763

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    End point title
    		 Accumulation Ratio (Racc) of LMB763
    End point description
    PK analysis set included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 LMB763 100 mg LMB763 50 mg
    Number of subjects analysed
    24 [20]
    42 [21]
    Units: ratio
        arithmetic mean (standard deviation)
    0.903 ± 0.472
    1.31 ± 0.641
    Notes
    [20] - PD analysis set.
    [21] - PD analysis set.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)

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    End point title
    		 Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)
    End point description
    Subjects were to undergo MRI twice (Baseline and End of Treatment) during the course of the study to quantitate liver fat. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 84 (Week 12)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    35 [22]
    44 [23]
    39 [24]
    Units: percentage of liver fat
    geometric mean (geometric coefficient of variation)
        Baseline for Day 84 Analysis
    18.751 ± 37.4
    17.715 ± 42.6
    17.476 ± 73.9
        Change from Baseline at Day 84
    0.648 ± 29.3
    0.681 ± 38.6
    0.962 ± 22.2
    Notes
    [22] - PD analysis set: n = 22, 22
    [23] - PD analysis set: n = 41, 41
    [24] - PD analysis set: n = 32, 32
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weight

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    End point title
    		 Change From Baseline in Weight
    End point description
    Baseline was defined as the last available measurement prior to the first dose. PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 28, 42, 56, 84 and 112 (EOS)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [25]
    44 [26]
    40 [27]
    Units: kilogram (kg)
    arithmetic mean (standard deviation)
        Baseline for Day 28 Analysis
    99.07 ± 22.560
    97.82 ± 17.829
    95.47 ± 22.921
        Change from Baseline at Day 28
    -0.78 ± 1.591
    -0.71 ± 1.725
    -0.17 ± 1.516
        Baseline for Day 42 Analysis
    96.89 ± 22.135
    97.82 ± 17.829
    95.30 ± 23.465
        Change from Baseline at Day 42
    -1.04 ± 1.683
    -1.08 ± 2.335
    -0.24 ± 1.677
        Baseline for Day 56 Analysis
    97.07 ± 22.555
    97.86 ± 18.043
    95.71 ± 23.244
        Change from Baseline at Day 56
    -1.39 ± 1.970
    -1.39 ± 2.188
    -0.26 ± 1.777
        Baseline for Day 84 Analysis
    97.34 ± 23.370
    97.11 ± 17.905
    95.91 ± 23.563
        Change from Baseline at Day 84
    -1.47 ± 2.169
    -2.02 ± 3.451
    -0.21 ± 1.989
        Baseline for Day 112 (EOS) Analysis
    98.74 ± 23.941
    95.38 ± 14.810
    95.85 ± 23.926
        Change from Baseline at Day 112 (EOS)
    -1.26 ± 3.014
    -1.66 ± 3.543
    0.35 ± 2.125
    Notes
    [25] - PD analysis set. n = 30, 30, 27, 27, 26, 26, 24, 24, 22, 22
    [26] - PD analysis set. n = 43, 43, 43, 43, 42, 42, 40, 40, 39, 39
    [27] - PD analysis set. n = 37, 37, 34, 34, 35, 35, 34, 34, 33, 33
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Mass Index (BMI)

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    End point title
    		 Change From Baseline in Body Mass Index (BMI)
    End point description
    Baseline was defined as the last available measurement prior to the first dose at specified visit (day). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 28, 42, 56, 84 and 112 (EOS)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [28]
    44 [29]
    40 [30]
    Units: kilograms per metre square (kg/m^2)
    arithmetic mean (standard deviation)
        Baseline for Day 28 Analysis
    34.81 ± 5.641
    34.41 ± 5.270
    34.93 ± 5.180
        Change from Baseline at Day 28
    -0.29 ± 0.545
    -0.26 ± 0.638
    -0.05 ± 0.511
        Baseline for Day 42 Analysis
    34.05 ± 5.162
    34.41 ± 5.270
    34.56 ± 5.233
        Change from Baseline at Day 42
    -0.36 ± 0.591
    -0.40 ± 0.845
    -0.08 ± 0.572
        Baseline for Day 56 Analysis
    34.12 ± 5.253
    34.37 ± 5.327
    34.75 ± 5.269
        Change from Baseline at Day 56
    -0.50 ± 0.688
    -0.49 ± 0.799
    -0.10 ± 0.663
        Baseline for Day 84 Analysis
    34.18 ± 5.467
    34.04 ± 5.190
    34.89 ± 5.275
        Change from Baseline at Day 84
    -0.52 ± 0.764
    -0.72 ± 1.215
    -0.09 ± 0.718
        Baseline for Day 112 (EOS) Analysis
    34.60 ± 5.522
    33.82 ± 4.980
    34.96 ± 5.342
        Change from Baseline at Day 112 (EOS)
    -0.45 ± 0.974
    -0.60 ± 1.276
    0.12 ± 0.776
    Notes
    [28] - PD analysis set. n = 30, 30, 27, 27, 26, 26, 24, 24, 22, 22
    [29] - PD analysis set. n = 43, 43, 43, 43, 42, 42, 40, 40, 39, 39
    [30] - PD analysis set. n = 37, 37, 34, 34, 35, 35, 34, 34, 33, 33
    No statistical analyses for this end point

    Secondary: Change From Baseline in Waist to Hip Ratio

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    End point title
    		 Change From Baseline in Waist to Hip Ratio
    End point description
    Baseline was defined as the last available measurement prior to the first dose. PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 28, 42, 56, 84 and 112 (EOS)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [31]
    44 [32]
    40 [33]
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline for Day 28 Analysis
    0.96 ± 0.065
    0.96 ± 0.055
    0.95 ± 0.089
        Change from Baseline at Day 28
    0.00 ± 0.039
    0.00 ± 0.034
    -0.00 ± 0.039
        Baseline for Day 42 Analysis
    0.96 ± 0.061
    0.95 ± 0.056
    0.96 ± 0.086
        Change from Baseline at Day 42
    0.01 ± 0.077
    -0.00 ± 0.039
    0.00 ± 0.036
        Baseline for Day 56 Analysis
    0.96 ± 0.061
    0.96 ± 0.054
    0.96 ± 0.087
        Change from Baseline at Day 56
    -0.00 ± 0.029
    -0.00 ± 0.033
    -0.01 ± 0.029
        Baseline for Day 84 Analysis
    0.95 ± 0.063
    0.96 ± 0.055
    0.96 ± 0.087
        Change from Baseline at Day 84
    0.00 ± 0.043
    -0.01 ± 0.044
    0.01 ± 0.046
        Baseline for Day 112 (EOS) Analysis
    0.96 ± 0.059
    0.96 ± 0.054
    0.96 ± 0.087
        Change from Baseline at Day 112 (EOS)
    -0.00 ± 0.030
    0.00 ± 0.050
    -0.00 ± 0.037
    Notes
    [31] - PD analysis set. n = 30, 30, 27, 27, 25, 25, 24, 24, 22, 22
    [32] - PD analysis set. n = 43, 43, 40, 40, 42, 42, 40, 40, 39, 39
    [33] - PD analysis set. n = 36, 36, 34, 34, 34, 34 , 34, 34, 33, 33
    No statistical analyses for this end point

    Secondary: Change From to Baseline in Liver Stiffness

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    End point title
    		 Change From to Baseline in Liver Stiffness
    End point description
    Fibroscan® was performed where available to assess liver stiffness. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data.'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 84 (Week 12)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    10 [34]
    17 [35]
    18 [36]
    Units: kilopascal (kPa)
    geometric mean (geometric coefficient of variation)
        Baseline for Day 84 Analysis
    7.689 ± 71.1
    6.082 ± 29.5
    7.108 ± 52.5
        Change from Baseline at Day 84
    0.955 ± 35.3
    1.053 ± 26.9
    1.041 ± 38.6
    Notes
    [34] - PD analysis set: n = 7, 7
    [35] - PD analysis set: n = 15, 15
    [36] - PD analysis set: n = 16, 16
    No statistical analyses for this end point

    Secondary: Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel

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    End point title
    		 Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel
    End point description
    Enhanced liver fibrosis test (ELF) panel included hyaluronic acid (HA), tissue inhibitor of metalloproteinases (TIMP-1), and amino-terminal pro-peptide of procollagen type III (PIIINP) as markers of liver fibrosis. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 42 and 84
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [37]
    44 [38]
    40 [39]
    Units: ELF score
    geometric mean (geometric coefficient of variation)
        Baseline for Day 42 Analysis
    9.063 ± 7.3
    8.731 ± 8.2
    9.212 ± 8.0
        Change from Baseline at Day 42
    1.005 ± 5.5
    1.016 ± 5.8
    1.009 ± 7.5
        Baseline for Day 84 Analysis
    9.051 ± 7.7
    8.739 ± 8.4
    9.220 ± 7.8
        Change from Baseline at Day 84
    1.005 ± 5.9
    1.030 ± 6.2
    1.007 ± 6.3
    Notes
    [37] - PD analysis set. n = 26, 26, 24, 24
    [38] - PD analysis set. n = 42, 42, 37, 37
    [39] - PD analysis set. n = 33, 33, 33, 33
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fibrosis Biomarker Test

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    End point title
    		 Change From Baseline in Fibrosis Biomarker Test
    End point description
    Fibrosis Biomarker test included hyaluronic acid (HA), amino-terminal pro-peptide of procollagen type III (PIIINP), and tissue inhibitor of metalloproteinases (TIMP-1) as markers of liver fibrosis. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 42 and 84
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [40]
    44 [41]
    40 [42]
    Units: micrograms per litre (ug/L)
    geometric mean (geometric coefficient of variation)
        HA: Baseline for Day 42 Analysis
    33.646 ± 72.2
    26.869 ± 75.4
    39.282 ± 74.9
        HA: Change from Baseline at Day 42
    1.002 ± 49.5
    1.133 ± 54.4
    1.111 ± 77.0
        HA: Baseline for Day 84 Analysis
    32.246 ± 72.9
    27.320 ± 78.2
    40.865 ± 79.5
        HA: Change from Baseline at Day 84
    1.023 ± 54.0
    1.254 ± 51.4
    1.071 ± 64.9
        PIIINP: Baseline for Day 42 Analysis
    9.023 ± 31.3
    7.850 ± 28.2
    9.087 ± 35.5
        PIIINP: Change from Baseline at Day 42
    1.016 ± 22.8
    1.071 ± 24.3
    1.010 ± 26.4
        PIIINP: Baseline for Day 84 Analysis
    9.263 ± 34.6
    7.859 ± 27.4
    8.934 ± 32.3
        PIIINP: Change from Baseline at Day 84
    1.003 ± 21.2
    1.048 ± 26.9
    1.004 ± 20.1
        TIMP-1: Baseline for Day 42 Analysis
    242.99 ± 17.5
    199.21 ± 78.4
    254.37 ± 23.1
        TIMP-1: Change from Baseline at Day 42
    1.060 ± 14.6
    1.017 ± 11.9
    0.995 ± 13.3
        TIMP-1: Baseline for Day 84 Analysis
    247.42 ± 18.8
    193.32 ± 83.6
    245.09 ± 20.5
        TIMP-1: Change from Baseline at Day 84
    1.073 ± 17.0
    1.036 ± 10.4
    1.000 ± 19.2
    Notes
    [40] - PD analysis set. n = 26, 26, 24, 24, 26, 26, 24, 24, 26, 26, 24,24
    [41] - PD analysis set. n = 43, 43, 38, 38, 43, 43, 38, 38, 43, 43, 38, 38
    [42] - PD analysis set. n = 33, 33, 33, 33, 33, 33, 33, 33, 33, 33, 33, 33
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)

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    End point title
    		 Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)
    End point description
    Lipid measurements were collected under fasted conditions. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [43]
    44 [44]
    40 [45]
    Units: milligrams per decilitre (mg/dL)
    geometric mean (geometric coefficient of variation)
        Chol: Baseline for Day 7 Analysis
    184.85 ± 23.0
    183.30 ± 22.1
    188.97 ± 22.0
        Chol: Change from Baseline at Day 7
    0.957 ± 14.5
    1.001 ± 9.0
    1.002 ± 10.2
        Chol: Baseline for Day 14 Analysis
    186.57 ± 23.1
    183.30 ± 22.1
    188.97 ± 22.0
        Chol: Change from Baseline at Day 14
    0.963 ± 17.0
    1.037 ± 11.8
    1.000 ± 10.4
        Chol: Baseline for Day 28 Analysis
    188.09 ± 23.2
    183.50 ± 22.3
    190.44 ± 22.4
        Chol: Change from Baseline at Day 28
    0.952 ± 15.2
    1.025 ± 14.6
    1.007 ± 12.2
        Chol: Baseline for Day 42 Analysis
    206.50 ± 18.3
    182.59 ± 22.3
    191.65 ± 21.1
        Chol: Change from Baseline at Day 42
    0.943 ± 17.2
    1.001 ± 15.1
    0.940 ± 14.2
        Chol: Baseline for Day 56 Analysis
    192.25 ± 22.5
    182.39 ± 22.5
    190.33 ± 21.0
        Chol: Change from Baseline at Day 56
    0.963 ± 17.2
    1.033 ± 16.1
    1.002 ± 15.2
        Chol: Baseline for Day 84 Analysis
    188.88 ± 22.0
    181.63 ± 22.4
    187.20 ± 23.6
        Chol: Change from Baseline at Day 84
    0.958 ± 17.9
    1.037 ± 18.9
    1.006 ± 13.5
        Chol: Baseline for Day 112 (EOS) Analysis
    187.34 ± 22.8
    181.47 ± 22.0
    187.13 ± 23.1
        Chol: Change from Baseline at Day 112 (EOS)
    0.989 ± 13.6
    1.039 ± 16.8
    1.009 ± 13.2
        TG: Baseline for Day 7 Analysis
    185.66 ± 55.0
    198.88 ± 47.8
    175.18 ± 58.7
        TG: Change from Baseline at Day 7
    0.876 ± 38.8
    0.854 ± 25.8
    1.020 ± 28.6
        TG: Baseline for Day 14 Analysis
    178.22 ± 50.5
    198.88 ± 47.8
    175.18 ± 58.7
        TG: Change from Baseline at Day 14
    0.864 ± 36.2
    0.881 ± 28.1
    1.013 ± 35.9
        TG: Baseline for Day 28 Analysis
    166.54 ± 45.0
    201.00 ± 47.7
    177.66 ± 60.6
        TG: Change from Baseline at Day 28
    0.968 ± 36.4
    0.937 ± 37.0
    0.971 ± 33.7
        TG: Baseline for Day 42 Analysis
    181.97 ± 44.6
    203.65 ± 47.4
    174.48 ± 64.4
        TG: Change from Baseline at Day 42
    0.868 ± 34.5
    0.872 ± 36.1
    0.920 ± 35.2
        TG: Baseline for Day 56 Analysis
    167.66 ± 47.5
    202.64 ± 48.8
    174.78 ± 60.6
        TG: Change from Baseline at Day 56
    0.932 ± 34.2
    0.948 ± 38.9
    0.965 ± 28.1
        TG: Baseline for Day 84 Analysis
    163.71 ± 48.6
    201.96 ± 49.5
    184.99 ± 59.7
        TG: Change from Baseline at Day 84
    0.863 ± 43.8
    0956 ± 45.8
    0.947 ± 33.3
        TG: Baseline for Day 112 (EOS) Analysis
    172.80 ± 46.1
    203.55 ± 49.2
    179.36 ± 62.5
        TG: Change from Baseline at Day 112 (EOS)
    0.931 ± 38.5
    1.003 ± 39.9
    1.039 ± 39.0
    Notes
    [43] - PD analysis: n=36,36,34,34,29,29,19,19,25,25,24,24,22,22,36,36,34,34,29,29,19,19,25,25,24,24,22,22
    [44] - PD analysis: n=44,44,44,44,43,43,42,42,41,41,40,40,39,39,44,44,44,44,43,43,42,42,41,41,40,40, 39,39
    [45] - PD analysis: n=40,40,40,40,37,37,30,30,33,33,32,32,33,33,40,40,40,40,37,37,30,30,33,33,32,32,33,33
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol

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    End point title
    		 Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol
    End point description
    Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain). PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [46]
    44 [47]
    40 [48]
    Units: millimole per litre (mmol/L)
    geometric mean (geometric coefficient of variation)
        HDL: Baseline for Day 7 Analysis
    1.059 ± 30.0
    1.014 ± 25.4
    1.206 ± 28.2
        HDL: Change from Baseline at Day 7
    0.874 ± 15.0
    0.969 ± 10.0
    1.017 ± 12.7
        HDL: Baseline for Day 14 Analysis
    1.093 ± 24.8
    1.014 ± 25.4
    1.206 ± 28.2
        HDL: Change from Baseline at Day 14
    0.876 ± 19.1
    0.982 ± 13.4
    0.979 ± 10.0
        HDL: Baseline for Day 28 Analysis
    1.143 ± 23.8
    1.014 ± 25.7
    1.221 ± 28.9
        HDL: Change from Baseline at Day 28
    0.862 ± 14.1
    0.952 ± 15.1
    1.009 ± 14.7
        HDL: Baseline for Day 42 Analysis
    1.172 ± 26.9
    1.007 ± 25.7
    1.212 ± 30.6
        HDL: Change from Baseline at Day 42
    0.888 ± 19.4
    0.941 ± 15.5
    1.005 ± 12.2
        HDL: Baseline for Day 56 Analysis
    1.148 ± 25.5
    1.008 ± 25.9
    1.226 ± 29.1
        HDL: Change from Baseline at Day 56
    0.875 ± 17.0
    0.956 ± 15.1
    1.022 ± 13.9
        HDL: Baseline for Day 84 Analysis
    1.158 ± 24.9
    1.016 ± 26.6
    1.219 ± 29.7
        HDL: Change from Baseline at Day 84
    0.891 ± 16.1
    0.920 ± 19.9
    1.031 ± 12.5
        HDL: Baseline for Day 112 (EOS) Analysis
    1.115 ± 22.1
    1.013 ± 26.1
    1.218 ± 29.6
        HDL: Change from Baseline at Day 112 (EOS)
    1.004 ± 14.5
    1.037 ± 17.2
    1.007 ± 11.5
        LDL: Baseline for Day 7 Analysis
    2.647 ± 39.0
    2.591 ± 40.6
    2.628 ± 34.2
        LDL: Change from Baseline at Day 7
    1.009 ± 18.7
    1.076 ± 20.2
    0.977 ± 17.1
        LDL: Baseline for Day 14 Analysis
    2.664 ± 39.8
    2.591 ± 40.6
    2.666 ± 34.3
        LDL: Change from Baseline at Day 14
    1.021 ± 23.6
    1.125 ± 19.7
    0.998 ± 14.3
        LDL: Baseline for Day 28 Analysis
    2.612 ± 39.4
    2.553 ± 40.7
    2.614 ± 36.3
        LDL: Change from Baseline at Day 28
    0.996 ± 27.5
    1.092 ± 23.0
    1.017 ± 15.7
        LDL: Baseline for Day 42 Analysis
    3.070 ± 28.7
    2.559 ± 41.0
    2.679 ± 35.1
        LDL: Change from Baseline at Day 42
    0.989 ± 29.9
    1.079 ± 24.5
    0.914 ± 21.1
        LDL: Baseline for Day 56 Analysis
    2.841 ± 32.0
    2.527 ± 42.0
    2.621 ± 36.0
        LDL: Change from Baseline at Day 56
    1.011 ± 27.9
    1.091 ± 24.8
    0.991 ± 24.7
        LDL: Baseline for Day 84 Analysis
    2.725 ± 30.8
    2.528 ± 41.8
    2.498 ± 36.8
        LDL: Change from Baseline at Day 84
    1.029 ± 22.5
    1.107 ± 31.7
    1.025 ± 22.2
        LDL: Baseline for Day 112 (EOS) Analysis
    2.695 ± 31.6
    2.418 ± 40.0
    2.482 ± 36.2
        LDL: Change from Baseline at Day 112 (EOS)
    1.010 ± 18.7
    1.035 ± 34.1
    1.026 ± 19.9
    Notes
    [46] - PD analysis: n=36,36,34,34,29,29,19,19,24,24,24,24,22,22,34,34,33,33,29,29,19,19,24,24,24,24,22,22
    [47] - PD analysis: n=44,44,44,44,43,43,42,42,41,41,40,40,39,39,43,43,43,43,41,41,41,41,38,38,38,38,35,35
    [48] - PD analysis: n=40,40,40,40,37,37,30,30,33,33,32,32,33,33,37,37,35,35,36,36,28,28,32,32,29,29,29,29
    No statistical analyses for this end point

    Secondary: Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin

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    End point title
    		 Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin
    End point description
    A 10 cm VAS was used to assess the severity of subjects itch (ranging from 0 = no itch at all to 10 = the worst imaginable itch). The score (distance from left) on the VAS was recorded by the subject marking with a line and used to test for an effect of LMB763 over placebo. Baseline was defined as the last available measurement prior to the first dose. A positive change from Baseline indicates improvement. PD analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. 'n' represents the number of subjects in each category with a value at both Baseline and that time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 84 (Week 12)
    End point values
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Number of subjects analysed
    37 [49]
    44 [50]
    40 [51]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline for Day 84 Analysis
    8.87 ± 19.108
    4.62 ± 10.356
    9.68 ± 19.552
        Change from Baseline at Day 84
    9.35 ± 18.746
    4.85 ± 21.798
    2.03 ± 24.037
    Notes
    [49] - PD analysis set: n = 23, 23
    [50] - PD analysis set: n = 39, 39
    [51] - PD analysis set: n = 34, 34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until LPLV (up to Day 112 (EOS)).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    LMB763 100 mg
    Reporting group description
    		 LMB763 100 mg

    Reporting group title
    LMB763 50 mg
    Reporting group description
    		 LMB763 50 mg

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Pooled Placebo

    Serious adverse events
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 44 (6.82%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign small intestinal neoplasm
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LMB763 100 mg LMB763 50 mg Pooled Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 37 (94.59%)
    37 / 44 (84.09%)
    33 / 40 (82.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Lipoma
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Discomfort
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 44 (4.55%)
    4 / 40 (10.00%)
         occurrences all number
    2
    2
    4
    Feeling cold
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Ovarian calcification
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 44 (4.55%)
    2 / 40 (5.00%)
         occurrences all number
    4
    3
    2
    Dyspnoea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Sneezing
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    3 / 40 (7.50%)
         occurrences all number
    0
    1
    3
    Insomnia
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 44 (4.55%)
    0 / 40 (0.00%)
         occurrences all number
    2
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 44 (4.55%)
    4 / 40 (10.00%)
         occurrences all number
    1
    2
    4
    Albumin urine present
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Alpha-2 macroglobulin
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Alpha-2 macroglobulin increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Apolipoprotein A-I decreased
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 37 (10.81%)
    1 / 44 (2.27%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    1
    Bacterial test positive
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Basophil count increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    3
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    3
    Blood creatinine increased
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    3
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    2 / 40 (5.00%)
         occurrences all number
    1
    1
    2
    Blood triglycerides increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urea increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urine present
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Crystal urine present
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    2
    Free fatty acids increased
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    0
    2
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Low density lipoprotein decreased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    0
    Lymphocyte count increased
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    4 / 37 (10.81%)
    1 / 44 (2.27%)
    4 / 40 (10.00%)
         occurrences all number
    6
    1
    4
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Urine albumin/creatinine ratio
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    2 / 37 (5.41%)
    4 / 44 (9.09%)
    5 / 40 (12.50%)
         occurrences all number
    3
    4
    5
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    7 / 37 (18.92%)
    8 / 44 (18.18%)
    3 / 40 (7.50%)
         occurrences all number
    10
    8
    3
    White blood cell count decreased
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    White blood cells urine positive
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    0
    2
    Fall
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    1 / 40 (2.50%)
         occurrences all number
    0
    2
    1
    Muscle strain
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    Wrist fracture
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Diabetic neuropathy
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 37 (0.00%)
    3 / 44 (6.82%)
    1 / 40 (2.50%)
         occurrences all number
    0
    3
    1
    Head discomfort
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    3 / 37 (8.11%)
    7 / 44 (15.91%)
    8 / 40 (20.00%)
         occurrences all number
    3
    8
    9
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Myasthenia gravis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 37 (2.70%)
    3 / 44 (6.82%)
    0 / 40 (0.00%)
         occurrences all number
    1
    3
    0
    Presyncope
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Motion sickness
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    2
    Abdominal pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    1
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 44 (4.55%)
    3 / 40 (7.50%)
         occurrences all number
    3
    2
    3
    Abnormal faeces
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    0
    Diarrhoea
         subjects affected / exposed
    4 / 37 (10.81%)
    4 / 44 (9.09%)
    4 / 40 (10.00%)
         occurrences all number
    6
    4
    7
    Dyspepsia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    3
    0
    3
    Faeces pale
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Melaena
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    7 / 37 (18.92%)
    5 / 44 (11.36%)
    2 / 40 (5.00%)
         occurrences all number
    7
    6
    3
    Tongue pruritus
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 37 (2.70%)
    3 / 44 (6.82%)
    0 / 40 (0.00%)
         occurrences all number
    1
    3
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Ecchymosis
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    20 / 37 (54.05%)
    13 / 44 (29.55%)
    6 / 40 (15.00%)
         occurrences all number
    28
    14
    6
    Pruritus generalised
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Psoriasis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Rash follicular
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Rash pruritic
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    0
    Skin atrophy
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Skin mass
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Renal disorder
         subjects affected / exposed
    0 / 37 (0.00%)
    4 / 44 (9.09%)
    1 / 40 (2.50%)
         occurrences all number
    0
    4
    1
    Urine abnormality
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Urine odour abnormal
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 37 (2.70%)
    3 / 44 (6.82%)
    1 / 40 (2.50%)
         occurrences all number
    1
    3
    1
    Bursitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 44 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    3 / 40 (7.50%)
         occurrences all number
    0
    3
    4
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 44 (2.27%)
    4 / 40 (10.00%)
         occurrences all number
    1
    1
    4
    Nail infection
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 44 (4.55%)
    3 / 40 (7.50%)
         occurrences all number
    2
    2
    3
    Oral herpes
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 44 (4.55%)
    0 / 40 (0.00%)
         occurrences all number
    2
    2
    0
    Tinea infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 37 (5.41%)
    4 / 44 (9.09%)
    2 / 40 (5.00%)
         occurrences all number
    3
    4
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    3 / 40 (7.50%)
         occurrences all number
    0
    2
    3
    Viral infection
         subjects affected / exposed
    0 / 37 (0.00%)
    4 / 44 (9.09%)
    1 / 40 (2.50%)
         occurrences all number
    0
    4
    2
    Viral myositis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Viral rhinitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    Gout
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 44 (2.27%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    4 / 37 (10.81%)
    4 / 44 (9.09%)
    0 / 40 (0.00%)
         occurrences all number
    4
    6
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 37 (0.00%)
    3 / 44 (6.82%)
    0 / 40 (0.00%)
         occurrences all number
    0
    4
    0
    Hypoglycaemia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 44 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 44 (4.55%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jan 2017
    Amendment 1 was generated in response to requests from the Medicines and Healthcare Products Regulatory Agency (MHRA) to include an additional pregnancy test and add serum phosphate to the clinical chemistry panel in accordance with the recommended renal monitoring procedures in the Investigator Brochure.
    01 May 2017
    Based on US FDA feedback regarding the potent inhibitory effects of nidufexor on CYP2C8 (Ki = 0.0213 μM, IC50 = 0.41 μM), which suggested a potential for drug-drug interactions (DDI) to occur between CYP2C8 substrates and nidufexor, the protocol was amended to highlight the potential for DDI and emphasize the potential for nidufexor to increase exposure of drugs metabolized by CYP2C8, including repaglinide, pioglitazone and rosiglitazone, and those dependent on export by BCRP. For all these drugs careful attention was paid to the drug interaction sections of the prescribing information.
    01 Oct 2017
    Amendment v03 aimed to explore a reduced dose of nidufexor which was expected to have a pharmacological effect on biomarkers of disease activity, as well as to lower the ALT threshold required for inclusion based on emerging data on the NASH phenotype and requirements for Phase 2 studies, and feedback received from investigators.

    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.
    The sponsor decided to terminate the study early, as data obtained were deemed sufficient to inform any potential future development steps; interim results showed that the 50 mg nidufexor dose was well tolerated with favourable efficacy.
    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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