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    Clinical Trial Results:
    A randomized, placebo-controlled, participant-andinvestigator- blinded, sponsor open-label study to evaluate the safety, tolerability, and efficacy with different dosing regimens of subcutaneously administered MBL949 in obese participants with or without type 2 diabetes mellitus

    Summary
    EudraCT number
    		 2021-004449-19
    Trial protocol
    		 DK  
    Global end of trial date
    11 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2024
    First version publication date
    19 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CMBL949A12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05199090
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office  , Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office  , Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives were: • To evaluate the safety and tolerability of different dosing regimens of MBL949 in obese subjects with or without T2DM. • To evaluate the effect of different dosing regimens of MBL949 on weight in obese subjects with or without T2DM at week 16.
    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
    10 Feb 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 126
    Worldwide total number of subjects
    126
    EEA total number of subjects
    0
    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)
    126
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 4 research centers in United States participated in the study.

    Pre-assignment
    Screening details
    		 Participants underwent a screening visit between Day -35 and Day -15 to determine their eligibility for the study. On Day 1, participants went to the clinic after an overnight fast of at least 10 hours to complete the Day 1 assessments prior to dosing.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MBL949 Arm 1
    Arm description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    MBL949
    Investigational medicinal product code
    MBL949
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of4.5 mg

    Arm title
    		 MBL949 Arm 2
    Arm description
    		 MBL949 two 3 mg doses followed by six doses of 4.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    MBL949
    Investigational medicinal product code
    MBL949
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MBL949 two 3 mg doses followed by six doses of 4.5 mg

    Arm title
    		 MBL949 Arm 3
    Arm description
    		 MBL949 one 12 mg dose followed by seven doses of 4.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    MBL949
    Investigational medicinal product code
    MBL949
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MBL949 one 12 mg dose followed by seven doses of 4.5 mg

    Arm title
    		 MBL949 Arm 4
    Arm description
    		 MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    MBL949
    Investigational medicinal product code
    MBL949
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg

    Arm title
    		 MBL949 Arm 5
    Arm description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    MBL949
    Investigational medicinal product code
    MBL949
    Other name
    Pharmaceutical forms
    Solution for injection/infusion, Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of7.5 mg

    Arm title
    		 Placebo
    Arm description
    		 Placebo to MBL949
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo to MBL949 formulated as solution for injection in vial for SC use

    Number of subjects in period 1
    		MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Placebo
    Started
    14
    22
    16
    15
    15
    44
    Completed
    12
    8
    15
    9
    10
    31
    Not completed
    2
    14
    1
    6
    5
    13
         Physician decision
    -
    -
    -
    -
    -
    1
         Adverse event, non-fatal
    1
    4
    -
    -
    -
    -
         Subject decision
    -
    4
    -
    2
    5
    2
         Study terminated by sponsor
    -
    6
    -
    -
    -
    5
         Lost to follow-up
    1
    -
    1
    4
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MBL949 Arm 1
    Reporting group description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg

    Reporting group title
    MBL949 Arm 2
    Reporting group description
    		 MBL949 two 3 mg doses followed by six doses of 4.5 mg

    Reporting group title
    MBL949 Arm 3
    Reporting group description
    		 MBL949 one 12 mg dose followed by seven doses of 4.5 mg

    Reporting group title
    MBL949 Arm 4
    Reporting group description
    		 MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg

    Reporting group title
    MBL949 Arm 5
    Reporting group description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to MBL949

    Reporting group values
    		 MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Placebo Total
    Number of subjects
    		 14 22 16 15 15 44 126
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 14 22 16 15 15 44 126
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ( 9.53 ) 45.8 ( 7.77 ) 44.8 ( 11.23 ) 45.8 ( 8.98 ) 41.6 ( 10.68 ) 44.0 ( 10.09 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 8 17 13 12 13 38 101
        Male
    		 6 5 3 3 2 6 25
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 3 4 2 6 3 11 29
        White
    		 11 18 14 9 12 33 97

    End points

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    End points reporting groups
    Reporting group title
    MBL949 Arm 1
    Reporting group description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 4.5 mg

    Reporting group title
    MBL949 Arm 2
    Reporting group description
    		 MBL949 two 3 mg doses followed by six doses of 4.5 mg

    Reporting group title
    MBL949 Arm 3
    Reporting group description
    		 MBL949 one 12 mg dose followed by seven doses of 4.5 mg

    Reporting group title
    MBL949 Arm 4
    Reporting group description
    		 MBL949 one 1.5 mg dose followed by seven doses of 2.2 mg

    Reporting group title
    MBL949 Arm 5
    Reporting group description
    		 MBL949 one 3 mg dose followed by two doses of 6 mg followed by five doses of 7.5 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to MBL949

    Subject analysis set title
    Pooled MBL949
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pooled MBL949 arms

    Subject analysis set title
    Pooled MBL949
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants from PD analysis set of the Pooled MBL949 arm with weight data at Baseline and Week 16 were included in the analysis.

    Primary: Frequency and severity of Adverse Events

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    End point title
    		 Frequency and severity of Adverse Events [1]
    End point description
    Number of participants with adverse events reported after the first dose of study medication or events present prior to treatment but increase in severity
    End point type
    Primary
    End point timeframe
    Baseline to Day 169
    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 primary outcome
    End point values
    		 MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Placebo Pooled MBL949
    Number of subjects analysed
    14
    22
    16
    15
    15
    44
    82
    Units: participants
        Total AEs
    11
    20
    15
    10
    14
    30
    70
        AEs of mild intensity
    10
    19
    15
    10
    14
    29
    68
        AEs of moderate intensity
    4
    8
    7
    3
    8
    7
    30
        AEs of severe intensity
    0
    2
    0
    1
    0
    2
    3
        Study drug-related AEs
    9
    18
    15
    8
    12
    19
    62
        Serious AEs
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Change-from-baseline in weight

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    End point title
    		 Change-from-baseline in weight
    End point description
    Baseline weight is defined as the last weight measurement before dosing in kilograms
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Placebo Pooled MBL949
    Number of subjects analysed
    12
    8
    15
    9
    10
    31
    54
    Units: kg
        arithmetic mean (confidence interval 90%)
    -2.6 (-3.8 to -1.5)
    -2.0 (-3.3 to -0.8)
    -2.0 (-3.0 to -0.9)
    -0.1 (-1.4 to 1.1)
    0.3 (-0.9 to 1.5)
    -0.7 (-1.4 to -0.0)
    -1.4 (-2.0 to -0.8)
    Statistical analysis title
    		 MBL949 Arm 1 vs placebo
    Statistical analysis description
    Comparison of adjusted means
    Comparison groups
    MBL949 Arm 1 v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0182
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    -1.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 -0.9
    Statistical analysis title
    		 MBL949 Arm 2 vs placebo
    Comparison groups
    MBL949 Arm 2 v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1205
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    -1.3
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.2
    Statistical analysis title
    		 MBL949 Arm 3 vs placebo
    Comparison groups
    MBL949 Arm 3 v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0931
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    -1.3
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.3
    Statistical analysis title
    		 MBL949 Arm 4 vs placebo
    Comparison groups
    MBL949 Arm 4 v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4994
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    0.6
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.7
    Statistical analysis title
    		 MBL949 Arm 5 vs placebo
    Comparison groups
    MBL949 Arm 5 v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2295
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    1
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 2.1
    Statistical analysis title
    		 Pooled MBL949 vs placebo
    Comparison groups
    Placebo v Pooled MBL949
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2114
    Method
    		 MMRM analysis
    Parameter type
    		 adjusted means
    Point estimate
    -0.7
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    erse events were reported from first dose of study treatment until end of study treatment plus 10 weeks post treatment, up to a maximum duration of 24 weeks.
    Adverse event reporting additional description
    Each treatment arm contains a different dosing scheme and adverse event data is provided for the full sequence.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    MBL949 Arm 1
    Reporting group description
    		 MBL949 Arm 1

    Reporting group title
    MBL949 Arm 2
    Reporting group description
    		 MBL949 Arm 2

    Reporting group title
    MBL949 Arm 3
    Reporting group description
    		 MBL949 Arm 3

    Reporting group title
    MBL949 Arm 4
    Reporting group description
    		 MBL949 Arm 4

    Reporting group title
    MBL949 Arm 5
    Reporting group description
    		 MBL949 Arm 5

    Reporting group title
    Pooled MBL949
    Reporting group description
    		 Pooled MBL949

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Pooled Placebo

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Pooled MBL949 Pooled Placebo Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 82 (0.00%)
    0 / 44 (0.00%)
    0 / 126 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MBL949 Arm 1 MBL949 Arm 2 MBL949 Arm 3 MBL949 Arm 4 MBL949 Arm 5 Pooled MBL949 Pooled Placebo Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 14 (78.57%)
    20 / 22 (90.91%)
    15 / 16 (93.75%)
    10 / 15 (66.67%)
    14 / 15 (93.33%)
    70 / 82 (85.37%)
    26 / 44 (59.09%)
    96 / 126 (76.19%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    4 / 82 (4.88%)
    0 / 44 (0.00%)
    4 / 126 (3.17%)
         occurrences all number
    0
    1
    2
    0
    1
    4
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 14 (0.00%)
    5 / 22 (22.73%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    8 / 82 (9.76%)
    0 / 44 (0.00%)
    8 / 126 (6.35%)
         occurrences all number
    0
    6
    1
    1
    1
    9
    0
    9
    Injection site pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    2 / 44 (4.55%)
    3 / 126 (2.38%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    2
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    1 / 44 (2.27%)
    2 / 126 (1.59%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    2
    Injection site reaction
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    3 / 82 (3.66%)
    2 / 44 (4.55%)
    5 / 126 (3.97%)
         occurrences all number
    4
    0
    1
    0
    1
    6
    4
    10
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 82 (2.44%)
    1 / 44 (2.27%)
    3 / 126 (2.38%)
         occurrences all number
    0
    1
    0
    0
    1
    2
    1
    3
    Oropharyngeal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    0
    2
    Investigations
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Lipase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Cortisol free urine increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Muscle contusion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    1 / 44 (2.27%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    2
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    3 / 82 (3.66%)
    1 / 44 (2.27%)
    4 / 126 (3.17%)
         occurrences all number
    1
    0
    1
    0
    1
    3
    1
    4
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 22 (18.18%)
    2 / 16 (12.50%)
    2 / 15 (13.33%)
    3 / 15 (20.00%)
    14 / 82 (17.07%)
    1 / 44 (2.27%)
    15 / 126 (11.90%)
         occurrences all number
    3
    4
    4
    2
    3
    16
    1
    17
    Taste disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Sinus headache
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    0
    2
    Syncope
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    3 / 82 (3.66%)
    0 / 44 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    1
    0
    1
    0
    1
    3
    0
    3
    Anal incontinence
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Constipation
         subjects affected / exposed
    3 / 14 (21.43%)
    5 / 22 (22.73%)
    5 / 16 (31.25%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    16 / 82 (19.51%)
    2 / 44 (4.55%)
    18 / 126 (14.29%)
         occurrences all number
    3
    5
    5
    1
    2
    16
    2
    18
    Dental caries
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 22 (9.09%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    6 / 82 (7.32%)
    5 / 44 (11.36%)
    11 / 126 (8.73%)
         occurrences all number
    0
    6
    2
    0
    4
    12
    10
    22
    Abdominal distension
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    3 / 82 (3.66%)
    5 / 44 (11.36%)
    8 / 126 (6.35%)
         occurrences all number
    2
    0
    0
    0
    1
    3
    5
    8
    Abdominal pain
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    5 / 82 (6.10%)
    1 / 44 (2.27%)
    6 / 126 (4.76%)
         occurrences all number
    3
    0
    0
    0
    2
    5
    2
    7
    Frequent bowel movements
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    2 / 82 (2.44%)
    1 / 44 (2.27%)
    3 / 126 (2.38%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    1
    3
    Dyspepsia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    10 / 22 (45.45%)
    8 / 16 (50.00%)
    6 / 15 (40.00%)
    7 / 15 (46.67%)
    32 / 82 (39.02%)
    3 / 44 (6.82%)
    35 / 126 (27.78%)
         occurrences all number
    1
    14
    18
    7
    12
    52
    3
    55
    Retching
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Nausea
         subjects affected / exposed
    9 / 14 (64.29%)
    17 / 22 (77.27%)
    14 / 16 (87.50%)
    6 / 15 (40.00%)
    12 / 15 (80.00%)
    58 / 82 (70.73%)
    17 / 44 (38.64%)
    75 / 126 (59.52%)
         occurrences all number
    22
    57
    39
    11
    44
    173
    27
    200
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 22 (4.55%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    3 / 82 (3.66%)
    0 / 44 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    1
    1
    1
    0
    0
    3
    0
    3
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    1 / 44 (2.27%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    2
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    1
    1
    0
    2
    0
    2
    Joint swelling
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    1 / 44 (2.27%)
    2 / 126 (1.59%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    2
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    0
    2
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    3 / 44 (6.82%)
    4 / 126 (3.17%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    5
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 22 (13.64%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    4 / 82 (4.88%)
    0 / 44 (0.00%)
    4 / 126 (3.17%)
         occurrences all number
    0
    3
    1
    0
    0
    4
    0
    4
    COVID-19
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    4 / 16 (25.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    6 / 82 (7.32%)
    6 / 44 (13.64%)
    12 / 126 (9.52%)
         occurrences all number
    0
    1
    4
    1
    0
    6
    6
    12
    Conjunctivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    1 / 44 (2.27%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    2
    Fungal foot infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 22 (13.64%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    9 / 82 (10.98%)
    1 / 44 (2.27%)
    10 / 126 (7.94%)
         occurrences all number
    0
    3
    2
    1
    3
    9
    1
    10
    Tinea cruris
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    5 / 82 (6.10%)
    3 / 44 (6.82%)
    8 / 126 (6.35%)
         occurrences all number
    0
    1
    2
    1
    1
    5
    5
    10
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    0
    2
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 22 (0.00%)
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    5 / 82 (6.10%)
    3 / 44 (6.82%)
    8 / 126 (6.35%)
         occurrences all number
    1
    0
    3
    0
    1
    5
    3
    8
    Hypoglycaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 22 (4.55%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    2
    0
    3
    0
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 22 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 82 (1.22%)
    0 / 44 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    Food aversion
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 22 (9.09%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 82 (2.44%)
    0 / 44 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2021
    The purpose of this amendment was to provide an update to the exclusion criteria for liver and renal parameters including cholelithiasis and pancreatitis.
    01 Jan 2022
    The purpose of this amendment was to update the PK sampling time points during the trial to adequately inform and characterize the PK profile of MBL949. The additional time points included the following: 24 h and 144 h post first dose (Day 2 and Day 7), and 144 h post eighth dose (Day 105). ADA were planned at pre-dose and end of study. However, to better understand the potential effect of MBL949 on immunogenicity over the course of the study, increased frequency of ADA measurements were added and coincided with the PK sampling time points.

    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 tolerability to benefit ratio based on maximum weight loss observed was not considered favorable at the doses studied and the study was terminated early.
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    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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