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    Clinical Trial Results:
    A trial comparing the efficacy and safety of once weekly dosing of somapacitan with daily Norditropin® in Chinese children with growth hormone deficiency

    Summary
    EudraCT number
    		 2020-002974-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2024
    First version publication date
    04 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN8640-4468
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04970654
    WHO universal trial number (UTN)
    		 U1111-1250-7530
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy of somapacitan vs Norditropin on longitudinal growth in Chinese children with growth hormone deficiency (GHD)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (October 2013) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (November 2016) including archiving of essential documents.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    22 Jul 2021
    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
    China: 110
    Worldwide total number of subjects
    110
    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)
    110
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 20 sites in China.

    Pre-assignment
    Screening details
    		 A total of 110 subjects were randomised in a 2:1 ratio to receive either somapacitan or Norditropin.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Norditropin
    Arm description
    		 Subjects received Norditropin 0.034 milligrams per kilogram (mg/kg) subcutaneously (s.c.) once daily with prefilled pen-injector for 52 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Norditropin
    Investigational medicinal product code
    Other name
    Norditropin FlexPro
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Norditropin 0.034 milligrams per kilogram (mg/kg) given subcutaneously (s.c.) once daily with prefilled pen-injector for 52 weeks.

    Arm title
    		 Somapacitan
    Arm description
    		 Subjects received somapacitan 0.16 milligrams per kilogram (mg/kg) s.c. once weekly with prefilled pen-injector for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Somapacitan
    Investigational medicinal product code
    Other name
    Sogroya
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Somapacitan 0.16 milligrams per kilogram (mg/kg) given s.c. once weekly with prefilled pen-injector for 52 weeks.

    Number of subjects in period 1
    		Norditropin Somapacitan
    Started
    36
    74
    Completed
    32
    71
    Not completed
    4
    3
         Unspecified
    2
    1
         Lost to follow-up
    1
    -
         Withdrawal by parent/guardian
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Norditropin
    Reporting group description
    		 Subjects received Norditropin 0.034 milligrams per kilogram (mg/kg) subcutaneously (s.c.) once daily with prefilled pen-injector for 52 weeks.

    Reporting group title
    Somapacitan
    Reporting group description
    		 Subjects received somapacitan 0.16 milligrams per kilogram (mg/kg) s.c. once weekly with prefilled pen-injector for 52 weeks.

    Reporting group values
    		 Norditropin Somapacitan Total
    Number of subjects
    		 36 74 110
    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)
    		 36 74 110
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.5 ( 2.3 ) 6.6 ( 2.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 6 9 15
        Male
    		 30 65 95

    End points

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    End points reporting groups
    Reporting group title
    Norditropin
    Reporting group description
    		 Subjects received Norditropin 0.034 milligrams per kilogram (mg/kg) subcutaneously (s.c.) once daily with prefilled pen-injector for 52 weeks.

    Reporting group title
    Somapacitan
    Reporting group description
    		 Subjects received somapacitan 0.16 milligrams per kilogram (mg/kg) s.c. once weekly with prefilled pen-injector for 52 weeks.

    Primary: Height Velocity

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    End point title
    		 Height Velocity
    End point description
    Height velocity (HV) at week 52 is reported and was derived from height measurements taken at baseline and week 52 visit in the following way: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    Height velocity (annualised) at week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    71
    Units: centimetres per year (cm/year)
        arithmetic mean (standard deviation)
    10.5 ( 2.3 )
    11.0 ( 2.1 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Height velocity at 52 weeks was analysed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.
    Comparison groups
    Norditropin v Somapacitan
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Treatment difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 1.3
    Notes
    [1] - The non-inferiority margin of -2.0 cm/year was used in the trial. Subjects in this analysis were 110 (as analysis is based on repeated measurements, all data till week 52 is included in the analysis), incorrectly displayed as 103.

    Secondary: Change in Height Standard Deviation Score (HSDS)

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    End point title
    		 Change in Height Standard Deviation Score (HSDS)
    End point description
    Change from baseline in HSDS at week 52 is reported. HSDS was derived using Chinese general population standards as reference data. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    69
    Units: Standard deviation score
        arithmetic mean (standard deviation)
    1.13 ( 0.48 )
    1.21 ( 0.46 )
    No statistical analyses for this end point

    Secondary: Change in Bone Age

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    End point title
    		 Change in Bone Age
    End point description
    Change in bone age from visit 1 (week -14) to week 52 is reported. X-rays of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From visit 1 (week -14) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    68
    Units: Years
        arithmetic mean (standard deviation)
    1.3 ( 0.6 )
    1.2 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Change in Height Velocity Standard Deviation Score (HV SDS)

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    End point title
    		 Change in Height Velocity Standard Deviation Score (HV SDS)
    End point description
    Change from baseline in HV SDS at week 52 is reported. HV SDS was derived using Prader standards as reference data & calculated as (height velocity - mean)/standard deviation (SD), where height velocity (HV) was the HV variable measured, mean and SD of HV by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a HV below the mean HV for a child with the same age and gender, whereas positive scores indicated a HV above the mean HV for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    69
    Units: Standard deviation score
        arithmetic mean (standard deviation)
    8.34 ( 3.01 )
    8.96 ( 3.53 )
    No statistical analyses for this end point

    Secondary: Change in Glycated Haemoglobin (HbA1c)

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    End point title
    		 Change in Glycated Haemoglobin (HbA1c)
    End point description
    Change from baseline in HbA1c at week 52 is reported. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Safety analysis set included all subjects randomly assigned to trial treatment & who took at least 1 dose of trial product. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    69
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    0.09 ( 0.31 )
    0.19 ( 0.25 )
    No statistical analyses for this end point

    Secondary: Change in Fasting Plasma Glucose (FPG)

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    End point title
    		 Change in Fasting Plasma Glucose (FPG)
    End point description
    Change from baseline in FPG at week 52 is reported. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Safety analysis set included all subjects randomly assigned to trial treatment & who took at least 1 dose of trial product. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    68
    Units: Millimoles per litre (mmol/L)
        arithmetic mean (standard deviation)
    0.541 ( 0.523 )
    0.304 ( 0.521 )
    No statistical analyses for this end point

    Secondary: Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)

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    End point title
    		 Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)
    End point description
    Change from baseline in IGF-I SDS at week 52 is reported. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For subjects with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    67
    Units: Standard deviation score
        arithmetic mean (standard deviation)
    1.73 ( 1.00 )
    2.09 ( 1.28 )
    No statistical analyses for this end point

    Secondary: Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS)

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    End point title
    		 Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS)
    End point description
    Change from baseline in IGFBP-3 SDS at week 52 is reported. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For subjects with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 (week 52) or 14 days after last administration, whichever came first. Full analysis set included all subjects randomised. Number of Subjects Analyzed = subjects who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Norditropin Somapacitan
    Number of subjects analysed
    32
    67
    Units: Standard deviation score
        arithmetic mean (standard deviation)
    0.93 ( 0.75 )
    1.06 ( 0.87 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to week 70
    Adverse event reporting additional description
    All presented adverse events are treatment emergent, defined as adverse events with onset after the first administration of trial product & up until 14 days after last trial drug administration. Safety analysis set included all subjects randomly assigned to trial treatment & who took at least 1 dose of trial product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    somapacitan
    Reporting group description
    		 Subjects received somapacitan 0.16 milligrams per kilogram (mg/kg) s.c. once weekly with prefilled pen-injector for 52 weeks.

    Reporting group title
    Norditropin
    Reporting group description
    		 Subjects received Norditropin subcutaneous (s.c.) 0.034 milligrams per kilogram (mg/kg) once daily with prefilled pen-injector for 52 weeks.

    Serious adverse events
    		 somapacitan Norditropin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 74 (10.81%)
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 somapacitan Norditropin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 74 (81.08%)
    29 / 36 (80.56%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    18 / 74 (24.32%)
    6 / 36 (16.67%)
         occurrences all number
    23
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 74 (4.05%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Dyspepsia
         subjects affected / exposed
    4 / 74 (5.41%)
    2 / 36 (5.56%)
         occurrences all number
    4
    2
    Gastritis
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 74 (16.22%)
    7 / 36 (19.44%)
         occurrences all number
    22
    12
    Rhinorrhoea
         subjects affected / exposed
    1 / 74 (1.35%)
    2 / 36 (5.56%)
         occurrences all number
    1
    3
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    11 / 74 (14.86%)
    7 / 36 (19.44%)
         occurrences all number
    11
    7
    Influenza
         subjects affected / exposed
    3 / 74 (4.05%)
    3 / 36 (8.33%)
         occurrences all number
    3
    4
    Respiratory tract infection
         subjects affected / exposed
    9 / 74 (12.16%)
    5 / 36 (13.89%)
         occurrences all number
    17
    9
    Rhinitis
         subjects affected / exposed
    1 / 74 (1.35%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Tonsillitis
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 36 (2.78%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    40 / 74 (54.05%)
    15 / 36 (41.67%)
         occurrences all number
    74
    24
    Bronchitis
         subjects affected / exposed
    7 / 74 (9.46%)
    4 / 36 (11.11%)
         occurrences all number
    7
    8
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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