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    Clinical Trial Results:
    A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency

    Summary
    EudraCT number
    		 2013-000830-37
    Trial protocol
    		 HU   SK   GR   GB   AT   ES   NL   PL  
    Global end of trial date
    17 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CP-4-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01909479
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OPKO Biologics Ltd.
    Sponsor organisation address
    Ashlagan 16, Kiryat Gat, Israel, 8211804
    Public contact
    OPKO Health, Inc., OPKO Health, Inc., contact@opko.com
    Scientific contact
    OPKO Health, Inc., OPKO Health, Inc., contact@opko.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
    17 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate a clinical superiority of MOD-4023 over placebo in terms of decrease in Trunk Fat Mass (FM) in adult subjects with GHD
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in, or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of study participants. The final protocol, any amendments, and informed consent documentation were reviewed and approved by the Institutional Review Board(s) (IRB) and/or Independent Ethics Committee(s) (IEC) at each of the investigational centers participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2013
    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
    Poland: 23
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Greece: 9
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Romania: 25
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    Ukraine: 18
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    202
    EEA total number of subjects
    78
    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)
    195
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 389 subjects were screened for entry into the Main Study and 202 subjects were randomized

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MOD-4023
    Arm description
    		 Individualized once weekly dose of MOD-4023
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOD-4023
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Individualized once weekly dose of MOD-4023

    Arm title
    		 Placebo
    Arm description
    		 Once weekly administration of placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    MOD-4023 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once weekly administration of placebo

    Number of subjects in period 1
    		MOD-4023 Placebo
    Started
    135
    67
    Completed
    129
    58
    Not completed
    6
    9
         Consent withdrawn by subject
    3
    6
         Adverse event, non-fatal
    3
    2
         SIte and study closed by PI
    -
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MOD-4023
    Arm description
    		 Individualized once weekly dose of MOD-4023
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOD-4023
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Individualized once weekly dose of MOD-4023

    Arm title
    		 MOD-4023 (Randomized as Placebo)
    Arm description
    		 Individualized once weekly dose of MOD-4023, patient who were initially randomized as Placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOD-4023
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Individualized once weekly dose of MOD-4023

    Number of subjects in period 2 [1]
    		MOD-4023 MOD-4023 (Randomized as Placebo)
    Started
    128
    58
    Completed
    125
    56
    Not completed
    3
    2
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One MOD-4023 subject that completed period 1 withdrew consent and did not continue to period 2
    Period 3
    Period 3 title
    Period 3 LT-OLE
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MOD-4023
    Arm description
    		 Individualized once weekly dose of MOD-4023
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOD-4023
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Individualized once weekly dose of MOD-4023

    Number of subjects in period 3 [2]
    		MOD-4023
    Started
    162
    Completed
    118
    Not completed
    44
         Sponsor's decision
    3
         Adverse event, serious fatal
    1
         Personal reasons
    3
         Consent withdrawn by subject
    20
         Adverse event, non-fatal
    3
         Inability to Continue the Study for Any Reason
    6
         Pregnancy
    1
         Diabetes not controlled on oral meds and liver tes
    1
         Evidence of growth of Intracranial Tumor
    2
         Lost to follow-up
    2
         Lack of Subject Compliance
    1
         Occurrence of Malignancy
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Treatment Period 3, the OLE 52-week period, isn't part of the main study. A total of 162 subjects signed the informed consent for the LT-OLE study and 161 subjects were treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MOD-4023
    Reporting group description
    		 Individualized once weekly dose of MOD-4023

    Reporting group title
    Placebo
    Reporting group description
    		 Once weekly administration of placebo

    Reporting group values
    		 MOD-4023 Placebo Total
    Number of subjects
    		 135 67 202
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 131 64 195
        From 65-84 years
    		 4 3 7
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 58 26 84
        Male
    		 77 41 118

    End points

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    End points reporting groups
    Reporting group title
    MOD-4023
    Reporting group description
    		 Individualized once weekly dose of MOD-4023

    Reporting group title
    Placebo
    Reporting group description
    		 Once weekly administration of placebo
    Reporting group title
    MOD-4023
    Reporting group description
    		 Individualized once weekly dose of MOD-4023

    Reporting group title
    MOD-4023 (Randomized as Placebo)
    Reporting group description
    		 Individualized once weekly dose of MOD-4023, patient who were initially randomized as Placebo
    Reporting group title
    MOD-4023
    Reporting group description
    		 Individualized once weekly dose of MOD-4023

    Primary: Change in Trunk FM, Expressed in Kilograms Measured With DXA, From Baseline to Week 26

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    End point title
    		 Change in Trunk FM, Expressed in Kilograms Measured With DXA, From Baseline to Week 26
    End point description
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    126
    56
    Units: kg
        number (not applicable)
    -0.3
    0.1
    Statistical analysis title
    		 Trunk FM (kg)
    Statistical analysis description
    Primary Efficacy Analysis: Trunk FM (kg) Change From Baseline in Treatment Period 1 - EP
    Comparison groups
    Placebo v MOD-4023
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0821
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 0.05

    Secondary: Change in Total FM, Expressed in Kilograms, Measured With DXA, From Baseline to 26 Weeks

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    End point title
    		 Change in Total FM, Expressed in Kilograms, Measured With DXA, From Baseline to 26 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    126
    56
    Units: kg
        number (not applicable)
    -0.18
    0.0
    Statistical analysis title
    		 Total FM (kg) Change
    Statistical analysis description
    Total FM (kg) Change and Percent Change From Baseline in Treatment Period 1 - EP
    Comparison groups
    MOD-4023 v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.577
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.55

    Secondary: Change in Lean Body Mass, Expressed in Kilograms Measured With DXA, From Baseline to 26

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    End point title
    		 Change in Lean Body Mass, Expressed in Kilograms Measured With DXA, From Baseline to 26
    End point description
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    126
    56
    Units: kg
        number (not applicable)
    1.3
    0.0
    Statistical analysis title
    		 Lean Body Mass Change (kg)
    Statistical analysis description
    Lean Body Mass (kg) Change and Percent Change From Baseline in Treatment Period 1 - EP
    Comparison groups
    Placebo v MOD-4023
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.9

    Secondary: Change in Lean Body Mass, Expressed in Kilograms Measured With DXA, From Baseline to 52

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    End point title
    		 Change in Lean Body Mass, Expressed in Kilograms Measured With DXA, From Baseline to 52
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    55
    Units: kg
        number (not applicable)
    1.6
    0.8
    No statistical analyses for this end point

    Secondary: Change in Trunk FM, Expressed in Kilograms Measured With DXA, From Baseline to 52 Weeks

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    End point title
    		 Change in Trunk FM, Expressed in Kilograms Measured With DXA, From Baseline to 52 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    55
    Units: kg
        number (not applicable)
    -0.2
    -0.3
    No statistical analyses for this end point

    Secondary: Change of IGF-I and IGF-I SDS levels across study visits in Period I

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    End point title
    		 Change of IGF-I and IGF-I SDS levels across study visits in Period I
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    130
    59
    Units: μg/L
        number (not applicable)
    85.6
    1.3
    No statistical analyses for this end point

    Secondary: Change of IGF-I and IGF-I SDS levels across study visits in Period 2

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    End point title
    		 Change of IGF-I and IGF-I SDS levels across study visits in Period 2
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    57
    Units: μg/L
        number (not applicable)
    100.6
    80.4
    No statistical analyses for this end point

    Secondary: Change of IGFBP-3 Levels Across Study Visits in Period 1

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    End point title
    		 Change of IGFBP-3 Levels Across Study Visits in Period 1
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    131
    59
    Units: μg/L
        number (not applicable)
    1266.4
    76.3
    No statistical analyses for this end point

    Secondary: Change of IGFBP-3 Levels Across Study Visits in Period 2

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    End point title
    		 Change of IGFBP-3 Levels Across Study Visits in Period 2
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    57
    Units: μg/L
        number (not applicable)
    1618.6
    1392.6
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Normalization of IGF-1 Levels During and at the End Treatment Period 1 and Period 2

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    End point title
    		 Proportion of Subjects Achieving Normalization of IGF-1 Levels During and at the End Treatment Period 1 and Period 2
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 Placebo MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    133
    65
    128
    58
    Units: Sublects
    130
    4
    127
    49
    No statistical analyses for this end point

    Secondary: Change in Total FM, Expressed in Kilograms, Measured With DXA, From Baseline to 52 Weeks

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    End point title
    		 Change in Total FM, Expressed in Kilograms, Measured With DXA, From Baseline to 52 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    55
    Units: kg
        number (not applicable)
    -0.06
    -0.19
    No statistical analyses for this end point

    Secondary: Change in Trunk FM, Expressed as % Change From Baseline, Measured With DXA, From Baseline to 26 Weeks

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    End point title
    		 Change in Trunk FM, Expressed as % Change From Baseline, Measured With DXA, From Baseline to 26 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 MOD-4023 Placebo
    Number of subjects analysed
    126
    56
    Units: kg
        number (not applicable)
    -0.9
    0.3
    Statistical analysis title
    		 Trunk FM as a Percentage of Total FM (kg)
    Comparison groups
    MOD-4023 v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 -0.77

    Secondary: Change in Trunk FM, Expressed as % Change From Baseline, Measured With DXA, From Baseline to 52 Weeks

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    End point title
    		 Change in Trunk FM, Expressed as % Change From Baseline, Measured With DXA, From Baseline to 52 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 MOD-4023 MOD-4023 (Randomized as Placebo)
    Number of subjects analysed
    125
    55
    Units: kg
        number (not applicable)
    -0.9
    -0.7
    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 throughout the 12 month treatment period 1 and Period 2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    MOD-4023 Period 1
    Reporting group description
    		 -

    Reporting group title
    Placebo Period 1
    Reporting group description
    		 Once weekly administration of placebo

    Reporting group title
    MOD-4023 Period 2
    Reporting group description
    		 Treatment Assignments at Period 1

    Reporting group title
    Placebo Period 2
    Reporting group description
    		 Treatment Assignments at Period 1

    Reporting group title
    MOD-4023 Period 3
    Reporting group description
    		 LT-OLE- Treatment Assignments at Period 1

    Reporting group title
    Placebo Period 3
    Reporting group description
    		 LT-OLE - Treatment Assignments at Period 1

    Serious adverse events
    		 MOD-4023 Period 1 Placebo Period 1 MOD-4023 Period 2 Placebo Period 2 MOD-4023 Period 3 Placebo Period 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 133 (3.01%)
    5 / 65 (7.69%)
    5 / 133 (3.76%)
    3 / 65 (4.62%)
    10 / 111 (9.01%)
    8 / 50 (16.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemianopia heteronymous
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric Disorder
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pituitary-dependent Cushing's syndrom
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 133 (0.75%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    1 / 111 (0.90%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    1 / 65 (1.54%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MOD-4023 Period 1 Placebo Period 1 MOD-4023 Period 2 Placebo Period 2 MOD-4023 Period 3 Placebo Period 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 133 (34.59%)
    33 / 65 (50.77%)
    28 / 133 (21.05%)
    16 / 65 (24.62%)
    56 / 111 (50.45%)
    37 / 50 (74.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 133 (8.27%)
    5 / 65 (7.69%)
    11 / 133 (8.27%)
    2 / 65 (3.08%)
    7 / 111 (6.31%)
    4 / 50 (8.00%)
         occurrences all number
    16
    5
    14
    3
    10
    8
    Paraesthesia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    12 / 133 (9.02%)
    9 / 65 (13.85%)
    4 / 133 (3.01%)
    4 / 65 (6.15%)
    4 / 111 (3.60%)
    4 / 50 (8.00%)
         occurrences all number
    32
    24
    26
    17
    57
    88
    Pyrexia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    7 / 111 (6.31%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    7
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 133 (3.01%)
    3 / 65 (4.62%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    4 / 111 (3.60%)
    3 / 50 (6.00%)
         occurrences all number
    4
    3
    0
    0
    5
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 133 (4.51%)
    3 / 65 (4.62%)
    3 / 133 (2.26%)
    6 / 65 (9.23%)
    3 / 111 (2.70%)
    5 / 50 (10.00%)
         occurrences all number
    7
    3
    4
    8
    3
    5
    Pain in extremity
         subjects affected / exposed
    2 / 133 (1.50%)
    4 / 65 (6.15%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 111 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 133 (3.76%)
    5 / 65 (7.69%)
    10 / 133 (7.52%)
    4 / 65 (6.15%)
    13 / 111 (11.71%)
    5 / 50 (10.00%)
         occurrences all number
    5
    5
    12
    5
    22
    6
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 133 (4.51%)
    4 / 65 (6.15%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    10 / 111 (9.01%)
    3 / 50 (6.00%)
         occurrences all number
    6
    6
    0
    0
    12
    4
    Bronchitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    4 / 111 (3.60%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    0
    5
    3
    Sinusitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    0 / 133 (0.00%)
    0 / 65 (0.00%)
    4 / 111 (3.60%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    0
    4
    8

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2014
    Amendment 1 1. An additional four possible weeks were added to the allowable screening period. 2. Exclusion criteria amended to clarify that ongoing administration of antidiabetic medications/agents would be exclusionary. 3. Exclusion criteria amended to clarify that any diagnosed or ongoing cancer, or history of cancer would be exclusionary. 4. Prolactin levels removed as safety endpoint. 5. A section detailing the use of an unblinded Medical Expert for dose modifications was added.
    07 Aug 2014
    Amendment 2 1. Treatment Period 3, the OLE 52-week period was added for the collection of additional safety data. Study conduct amended to include LT-OLE. 2. Specific inclusion and exclusion criteria for Treatment Period 3 added. 3. Additional measures amended to include: a. Change in QoL from baseline across study visits. b. Change in waist to hip ratio from baseline across study visits. c. Change in bone density from baseline on a yearly basis during Treatment Period 3. d. Change in fat and lean body mass from baseline on a yearly basis during Treatment Period 3. e. Change in lipid profile: fasting high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides, lipoprotein-a (Lp[a]) from baseline on a six months basis. 4. Clarification that Treatment Period 3 will continue until market approval in each country. 5. A secondary study objective was added: To monitor long-term safety and efficacy of somatrogon in adult subjects with GHD who completed Treatment Periods 1 and 2 of this study. 6. Treatment Period 2 and Treatment period 3 revised to clarify that no placebo group would be included. 7. Text added to indicate that during Treatment Period 3 Investigators would receive IGF-1 levels and make dose adjustments as needed.
    04 Jul 2016
    Amendment 3 1. A washout period of two to eight weeks was specified between Treatment Periods 2 and 3 and the signing of a Treatment Period 3 informed consent form (ICF) was described. 2. The assessment of adrenal function was added as a requirement for Treatment Period 2. 3. During the first year of Treatment Period 3 antibodies (Abs) would be assessed on dosing day, prior to dosing, and from the second year of Treatment Period 3 it would be done during regular clinic visits. 4. In the first year of Treatment Period 3, at Visit 20, the ECG assessment must be performed seven to 15 hours post dosing to assess cardiac activity at the time to maximum concentration. 5. Inclusion criteria for Treatment Period 3 was amended to clarify that subjects must have completed Treatment Periods 1 and 2 with adequate compliance 6. The exclusion criterion for Treatment Period 3 of > three months duration since the last dose of somatrogon could be waived by the Medical Monitor following evaluation of the subject. 7. Detectable NAb was removed as an exclusion to Treatment Period 3. 8. During Treatment Period 3, the IRT system would propose dose modifications to the Investigator, however the ultimate decision for dose modification would be the responsibility of the Investigator. 9. Thyroid and adrenal function would be performed at Visit 6 and Visit 10. 10. The primary EP was to consist of all intent-to-treat (ITT) subjects who received at least one dose of study treatment and had at least one post randomization measurement of trunk FM at Week 15 or Week 26.

    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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