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    Clinical Trial Results:
    A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients with Hypertriglyceridemia and Type 2 Diabetes.

    Summary
    EudraCT number
    		 2020-000065-16
    Trial protocol
    		 DE   LV  
    Global end of trial date
    03 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2023
    First version publication date
    26 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DS102A-07-CV1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04365400
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Afimmune
    Sponsor organisation address
    South County Business Park, Leopardstown, Dublin, Ireland, D18H5H9
    Public contact
    Regulatory Affairs Department, Afimmune, +353 12946380, afimmune.regulatory@afimmune.com
    Scientific contact
    Regulatory Affairs Department, Afimmune, +353 12946380, afimmune.regulatory@afimmune.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
    19 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy Objective: • To assess the efficacy of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes. Safety Objective: • To assess the safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes.
    Protection of trial subjects
    Investigators conducted the study according to the principles of the ICH E6 Guideline on GCP and the ethical principles that have their origins in the World Medical Association Declaration of Helsinki. The Investigator conducted all aspects of this study in accordance with all national, state and local laws or regulations.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    03 Aug 2020
    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 Kingdom: 26
    Country: Number of subjects enrolled
    Latvia: 24
    Country: Number of subjects enrolled
    Israel: 29
    Country: Number of subjects enrolled
    Georgia: 48
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    United States: 93
    Worldwide total number of subjects
    233
    EEA total number of subjects
    33
    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)
    153
    From 65 to 84 years
    80
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 7 countries.

    Pre-assignment
    Screening details
    		 In order to participate in this study, patients must meet all inclusion criteria and must not meet any of the exclusion criteria. Inclusion in the trial starts with the informed consent signature. The inclusion and exclusion criteria were verified at the first Screening Visit (Visit #1), confirmed at the second Screening Visit (Visit #2) and again

    Period 1
    Period 1 title
    Final Analysis (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    All study site personnel, as well as the personnel involved in the monitoring or conduct of the study, were blinded to the individual patient treatment assignments. Randomisation details were kept strictly confidential, accessible only in an emergency to authorised persons, until the time of formal unblinding. The blinded code for the trial was broken only after all patient data had been recorded and verified and the database locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Epeleuton 2g
    Arm description
    		 Two Epeleuton 500mg capsules and two placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Epeleuton 500mg Oral Capsules
    Investigational medicinal product code
    DS102
    Other name
    DS102 500mg Oral Capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Two Epeleuton 500mg capsules and two placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Arm title
    		 Epeleuton 4g
    Arm description
    		 Four Epeleuton 500mg capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Epeleuton 500mg Oral Capsules
    Investigational medicinal product code
    DS102
    Other name
    DS102 500mg Oral Capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four Epeleuton 500mg capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Four placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo 500mg Oral Capsules
    Investigational medicinal product code
    n/a
    Other name
    DS102 Placebo 500mg Oral Capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Number of subjects in period 1
    		Epeleuton 2g Epeleuton 4g Placebo
    Started
    79
    77
    77
    Completed
    49
    50
    50
    Not completed
    30
    27
    27
         Consent withdrawn by subject
    7
    8
    3
         Physician decision
    1
    -
    -
         Related to early termination
    18
    13
    -
         Adverse event, non-fatal
    3
    5
    6
         Related to trial termination
    -
    -
    17
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epeleuton 2g
    Reporting group description
    		 Two Epeleuton 500mg capsules and two placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Epeleuton 4g
    Reporting group description
    		 Four Epeleuton 500mg capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Four placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group values
    		 Epeleuton 2g Epeleuton 4g Placebo Total
    Number of subjects
    		 79 77 77 233
    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)
    		 48 52 53 153
        From 65-84 years
    		 31 25 24 80
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.3 ± 9.3 58.9 ± 10.2 58.8 ± 10.1 -
    Gender categorical
    Units: Subjects
        Female
    		 34 30 28 92
        Male
    		 45 47 49 141
    Race/Ethnicity
    Units: Subjects
        White
    		 75 74 70 219
        Asian
    		 1 2 4 7
        Black or African American
    		 2 1 1 4
        Other
    		 1 0 2 3

    End points

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    End points reporting groups
    Reporting group title
    Epeleuton 2g
    Reporting group description
    		 Two Epeleuton 500mg capsules and two placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Epeleuton 4g
    Reporting group description
    		 Four Epeleuton 500mg capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Four placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Primary: Primary: Percent change in triglycerides from baseline to week 16.

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    End point title
    		 Primary: Percent change in triglycerides from baseline to week 16.
    End point description
    Percent change in triglycerides from baseline to week 16.
    End point type
    Primary
    End point timeframe
    Up to 16 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -7.886 ± 4.096
    5.273 ± 5.361
    -5.130 ± 4.945
    Statistical analysis title
    		 4g V Placebo
    Comparison groups
    Epeleuton 4g v Placebo
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.114812
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges Lehmann Median
    Point estimate
    8.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.01
         upper limit
    		 18.19
    Statistical analysis title
    		 2g Vs Placebo
    Comparison groups
    Epeleuton 2g v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.866847
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges Lehmann Median
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.16
         upper limit
    		 7.96

    Primary: Primary: Change in HbA1c from baseline to week 26.

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    End point title
    		 Primary: Change in HbA1c from baseline to week 26.
    End point description
    Change in HbA1c from baseline to week 26.
    End point type
    Primary
    End point timeframe
    Up to 26 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change of HbA1C
        arithmetic mean (standard error)
    -2.255 ± 1.412
    -0.524 ± 1.162
    -0.503 ± 1.446
    Statistical analysis title
    		 4g V Placebo
    Comparison groups
    Epeleuton 4g v Placebo
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8658
    Method
    		 ANCOVA
    Parameter type
    		 Difference in change in HbA1c (%)
    Point estimate
    0.02516
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26658
         upper limit
    		 0.316897
    Statistical analysis title
    		 2g Vs Placebo
    Comparison groups
    Epeleuton 2g v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65
    Method
    		 ANCOVA
    Parameter type
    		 Difference in change in HbA1c (%)
    Point estimate
    -0.07333
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39012
         upper limit
    		 0.243455

    Secondary: Secondary: Percent change in triglycerides from baseline to week 4

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    End point title
    		 Secondary: Percent change in triglycerides from baseline to week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 4 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -9.301 ± 3.994
    5.965 ± 9.868
    -6.025 ± 4.479
    No statistical analyses for this end point

    Secondary: Secondary: Percent change in triglycerides from baseline to week 8

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    End point title
    		 Secondary: Percent change in triglycerides from baseline to week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -5.018 ± 3.843
    -4.500 ± 4.623
    -5.242 ± 4.411
    No statistical analyses for this end point

    Secondary: Secondary: Percent change in triglycerides from baseline to week 12

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    End point title
    		 Secondary: Percent change in triglycerides from baseline to week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -8.144 ± 4.071
    -4.215 ± 6.081
    4.022 ± 5.532
    No statistical analyses for this end point

    Secondary: Secondary: Percent change in triglycerides from baseline to week 20

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    End point title
    		 Secondary: Percent change in triglycerides from baseline to week 20
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -5.666 ± 4.665
    1.889 ± 5.005
    -4.270 ± 4.494
    No statistical analyses for this end point

    Secondary: Secondary: Percent change in triglycerides from baseline to week 26

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    End point title
    		 Secondary: Percent change in triglycerides from baseline to week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 26 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in TG
        arithmetic mean (standard error)
    -8.213 ± 4.882
    7.456 ± 6.585
    -0.675 ± 5.538
    No statistical analyses for this end point

    Secondary: Secondary: Change in HbA1c from baseline to week 4

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    End point title
    		 Secondary: Change in HbA1c from baseline to week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 4 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in HbA1c
        arithmetic mean (standard error)
    -2.606 ± 0.618
    -1.980 ± 0.683
    -1.365 ± 0.657
    No statistical analyses for this end point

    Secondary: Secondary: Change in HbA1c from baseline to week 8

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    End point title
    		 Secondary: Change in HbA1c from baseline to week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in HbA1c
        arithmetic mean (standard error)
    -3.327 ± 0.978
    -2.933 ± 0.815
    -2.913 ± 0.861
    No statistical analyses for this end point

    Secondary: Secondary: Change in HbA1c from baseline to week 12

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    End point title
    		 Secondary: Change in HbA1c from baseline to week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in HbA1c
        arithmetic mean (standard error)
    -3.448 ± 1.229
    -2.331 ± 1.052
    -1.315 ± 1.143
    No statistical analyses for this end point

    Secondary: Secondary: Change in HbA1c from baseline to week 16

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    End point title
    		 Secondary: Change in HbA1c from baseline to week 16
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in HbA1c
        arithmetic mean (standard error)
    -2.690 ± 1.338
    -1.733 ± 1.110
    -1.278 ± 1.216
    No statistical analyses for this end point

    Secondary: Secondary: Change in HbA1c from baseline to week 20

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    End point title
    		 Secondary: Change in HbA1c from baseline to week 20
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks
    End point values
    		 Epeleuton 2g Epeleuton 4g Placebo
    Number of subjects analysed
    76
    74
    76
    Units: % Change in HbA1c
        arithmetic mean (standard error)
    -4.176 ± 1.414
    -0.733 ± 1.188
    -0.811 ± 1.372
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 26 weeks
    Adverse event reporting additional description
    An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Epeleuton 2g
    Reporting group description
    		 Two Epeleuton 500mg capsules and two placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Epeleuton 4g
    Reporting group description
    		 Four Epeleuton 500mg capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Four placebo capsules orally administered twice a day, i.e. eight capsules daily for 26 weeks.

    Serious adverse events
    		 Epeleuton 2g Epeleuton 4g Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Epeleuton 2g Epeleuton 4g Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 79 (62.03%)
    52 / 77 (67.53%)
    42 / 77 (54.55%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 79 (6.33%)
    0 / 77 (0.00%)
    3 / 77 (3.90%)
         occurrences all number
    5
    0
    3
    Labile Hypertension
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    2
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    1 / 77 (1.30%)
         occurrences all number
    2
    2
    1
    Chest Pain
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    2
    0
    2
    Hunger
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Vaccination Site Pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Immunisation Reaction
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Seasonal Allergy
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Prostatic Dysplasia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    0
    0
    2
    Asthma
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Increased Upper Airway Secretion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    1
    1
    1
    Depression
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    2 / 77 (2.60%)
         occurrences all number
    0
    1
    2
    Blood Triglycerides Increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    1
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    Albumin Urine Present
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Blood Cholesterol Increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Glucose Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Blood Insulin Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Blood Pressure Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Body Temperature Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Electrocardiogram QRS Complex Abnormal
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram T Wave Abnormal
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Intraocular Pressure Increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Mean Cell Haemoglobin Concentration Decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Mean Cell Haemoglobin Decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Mean Cell Volume Decrease
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Occult Blood Positive
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    QRS Axis Abnormal
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    SARS-CoV-2 Test Positive
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Burns Third Degree
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctival Abrasion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Post Procedural Complication
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Atrioventricular Block First Degree
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    0
    1
    1
    Defect Conduction Intraventricular
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    1
    Bundle Branch Block Left
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle Branch Block Right
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac Failure
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Myocardial Infarction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus Tachycardia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 77 (1.30%)
    2 / 77 (2.60%)
         occurrences all number
    3
    1
    2
    Dysgeusia
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    Taste Disorder
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    Carotid Artery Stenosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Depressed level of Consciousness
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Lacunar Stroke
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Vocal Cord Paralysis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 77 (3.90%)
    0 / 77 (0.00%)
         occurrences all number
    0
    3
    0
    Ear Pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Open Angle Glaucoma
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Vitreous Detachment
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 79 (10.13%)
    13 / 77 (16.88%)
    6 / 77 (7.79%)
         occurrences all number
    10
    17
    6
    Nausea
         subjects affected / exposed
    2 / 79 (2.53%)
    6 / 77 (7.79%)
    3 / 77 (3.90%)
         occurrences all number
    2
    6
    4
    Dyspepsia
         subjects affected / exposed
    3 / 79 (3.80%)
    2 / 77 (2.60%)
    2 / 77 (2.60%)
         occurrences all number
    4
    2
    3
    Abdominal Pain
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 77 (3.90%)
    1 / 77 (1.30%)
         occurrences all number
    3
    4
    1
    Eructation
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 77 (3.90%)
    0 / 77 (0.00%)
         occurrences all number
    2
    3
    0
    Flatulence
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 77 (3.90%)
    1 / 77 (1.30%)
         occurrences all number
    0
    3
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    2
    3
    0
    Abdominal Distension
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    1
    1
    1
    Constipation
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    1
    0
    2
    Vomiting
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal Discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Dental Caries
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Diverticulum
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Dry Mouth
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Frequent Bowel Movements
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal Pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    1
    1
    0
    Diabetic Foot
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Macule
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    2
    0
    Urticaria
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Albuminuria
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Glycosuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Microalbuminuria
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Renal Impairment
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    1
    1
    1
    Back Pain
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    2
    1
    0
    Exostosis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    1
    Muscle Spasms
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Fibromyalgia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Pain In Extremity
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Synovial Cyst
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    7 / 79 (8.86%)
    2 / 77 (2.60%)
    5 / 77 (6.49%)
         occurrences all number
    8
    3
    7
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 77 (1.30%)
    2 / 77 (2.60%)
         occurrences all number
    1
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 77 (2.60%)
    1 / 77 (1.30%)
         occurrences all number
    0
    2
    1
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 77 (2.60%)
    0 / 77 (0.00%)
         occurrences all number
    1
    2
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    1
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    2
    0
    0
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea Infectious
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal Infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Giardiasis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Pulpitis Dental
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 77 (0.00%)
    1 / 77 (1.30%)
         occurrences all number
    0
    0
    1
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    0 / 77 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    4
    1
    1
    Hyperglycaemia
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 77 (1.30%)
    1 / 77 (1.30%)
         occurrences all number
    4
    1
    1
    Hypertriglyceridemia
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 77 (5.19%)
    0 / 77 (0.00%)
         occurrences all number
    0
    4
    0
    Diabetes Mellitus
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 77 (0.00%)
    2 / 77 (2.60%)
         occurrences all number
    1
    0
    2
    Decreased Appetite
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    1
    Iron Deficiency
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0
    Joint Swelling
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 77 (1.30%)
    0 / 77 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2021
    • Administrative Updates • Changes made to synopsis and text in point 2 of inclusion criteria section • Changes made to synopsis and text in point 3 of inclusion criteria section • Changes made to synopsis and text in point 8 of inclusion criteria section and point 13 of exclusion criteria section • Changes made to synopsis and text in point 9 of inclusion criteria section, deletion of point 1 of exclusion criteria section and addition of point 25 of exclusion criteria • Changes made throughout the protocol to add pregnancy testing and contraceptive counselling • Changes made to synopsis and text in point 9 of exclusion criteria section • Changes made to synopsis and text in point 27 of exclusion criteria section • Changes made throughout where diary is mentioned • Changes made to vital sign section • Addition of Interim Analysis Section • Addition of COVID-19 Contingency Section
    14 Jun 2021
    • Administrative Updates • Change made to LDL inclusion • Change made to BMI inclusion • Change to allow basal insulin • Addition of inclusion/exclusion criteria review at screening 2 • Addition of urine pregnancy test at baseline • Clarification that pre-trial background medication should stay stable through the study • Changes made to adverse event reporting • Changes made to unblinding procedure
    14 Feb 2022
    • Administrative Updates • Change to Statistical Methodology Section • Update to Interim Analysis Section • Clarification made to Exclusion 28. • Clarification on Protocol Deviations

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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