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    Clinical Trial Results:
    foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency

    Summary
    EudraCT number
    		 2020-000929-42
    Trial protocol
    		 DE   SK   FR   DK   BG   ES   NL   GR   IT  
    Global end of trial date
    01 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2025
    First version publication date
    26 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCH-306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04615273
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ascendis Pharma
    Sponsor organisation address
    Tuborg Boulevard 12, Hellerup, Denmark, DK-2900
    Public contact
    Clinical Trial Information Desk, Ascendis Pharma A/S, 0045 70222244, clinhelpdesk@ascendispharma.com
    Scientific contact
    Clinical Trial Information Desk, Ascendis Pharma A/S, 0045 70222244, clinhelpdesk@ascendispharma.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
    13 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of once-weekly lonapegsomatropin compared to placebo at 38 weeks in adults with growth hormone deficiency (GHD).
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation Harmonized Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2020
    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
    Poland: 38
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 11
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    United States: 48
    Country: Number of subjects enrolled
    Ukraine: 30
    Country: Number of subjects enrolled
    Georgia: 23
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    Türkiye: 14
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Serbia: 7
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Armenia: 6
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Romania: 2
    Worldwide total number of subjects
    259
    EEA total number of subjects
    84
    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)
    225
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 264 subjects randomised in the study, 259 subjects were treated in the study. Five randomised subjects did not receive the treatment.

    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
    Blinding implementation details
    Once-weekly lonapegsomatropin and once-weekly placebo treatment arms were double-blinded, daily somatropin product was open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lonapegsomatropin
    Arm description
    		 Subjects received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lonapegsomatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lonapegsomatropin administered once-weekly by subcutaneous injection.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for Lonapegsomatropin administered once-weekly by subcutaneous injection.

    Arm title
    		 Somatropin
    Arm description
    		 Subjects received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Somatropin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Somatropin administered once-daily by subcutaneous injection.

    Number of subjects in period 1
    		Lonapegsomatropin Placebo Somatropin
    Started
    89
    84
    86
    Treated
    89
    84
    86
    Completed
    85
    81
    82
    Not completed
    4
    3
    4
         Consent withdrawn by subject
    3
    1
    2
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    1
         Unspecified
    -
    1
    -
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lonapegsomatropin
    Reporting group description
    		 Subjects received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Somatropin
    Reporting group description
    		 Subjects received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group values
    		 Lonapegsomatropin Placebo Somatropin Total
    Number of subjects
    		 89 84 86 259
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.0 ( 13.40 ) 44.1 ( 14.74 ) 41.3 ( 14.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 42 39 38 119
        Male
    		 47 45 48 140
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 4 5 12
        Not Hispanic or Latino
    		 82 79 78 239
        Unknown or Not Reported
    		 4 1 3 8
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 1
        Asian
    		 11 8 9 28
        Black or African American
    		 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 72 71 75 218
        Other
    		 6 4 1 11
    Dose Group
    Units: Subjects
        Subgroup 1: Oral estrogen intake or <30 years old
    		 32 29 30 91
        Subgroup 2: >=30to<=60 years old; no oral estrogen
    		 46 43 45 134
        Subgroup 3: >60 years old; no oral estrogen intake
    		 11 12 11 34

    End points

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    End points reporting groups
    Reporting group title
    Lonapegsomatropin
    Reporting group description
    		 Subjects received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Somatropin
    Reporting group description
    		 Subjects received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.

    Primary: Change From Baseline in Trunk Percent Fat at Week 38

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    End point title
    		 Change From Baseline in Trunk Percent Fat at Week 38 [1]
    End point description
    Trunk percent fat was assessed by dual-energy X-ray absorptiometry. Analysis was performed on Intent-To-Treat population that consisted of all randomised subjects who received any amount of the trial drug and were analysed by the treatment arm as randomised. Here, “number of subjects analysed” = subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 38
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was analysed for lonapegsomatropin and placebo groups.
    End point values
    		 Lonapegsomatropin Placebo
    Number of subjects analysed
    82
    77
    Units: percent fat
        least squares mean (confidence interval 95%)
    -1.68 (-2.44 to -0.91)
    0.37 (-0.30 to 1.03)
    Statistical analysis title
    		 Lonapegsomatropin versus Placebo
    Statistical analysis description
    Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors & baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.
    Comparison groups
    Placebo v Lonapegsomatropin
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Estimate of Difference
    Point estimate
    -2.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 -1.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46

    Secondary: Change From Baseline in Total Body Lean Mass at Week 38

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    End point title
    		 Change From Baseline in Total Body Lean Mass at Week 38 [2]
    End point description
    Total body lean mass was assessed by dual-energy X-ray absorptiometry. Analysis was performed on Intent-to-Treat population. Here, “number of subjects analysed” = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 38
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was analysed for lonapegsomatropin and placebo groups.
    End point values
    		 Lonapegsomatropin Placebo
    Number of subjects analysed
    82
    77
    Units: kilograms
        least squares mean (confidence interval 95%)
    1.60 (1.00 to 2.19)
    -0.11 (-0.72 to 0.51)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Trunk Fat Mass at Week 38

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    End point title
    		 Change From Baseline in Trunk Fat Mass at Week 38 [3]
    End point description
    Trunk fat mass was assessed by dual-energy X-ray absorptiometry. Analysis was performed on Intent-to-Treat population. Here, “number of subjects analysed” = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 38
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was analysed for lonapegsomatropin and placebo groups.
    End point values
    		 Lonapegsomatropin Placebo
    Number of subjects analysed
    82
    77
    Units: kilograms
        least squares mean (confidence interval 95%)
    -0.48 (-0.89 to -0.07)
    0.22 (-0.15 to 0.60)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
    End point description
    An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE is any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalisation; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator. Analysis was performed on safety population that included all randomised subjects who received any amount of trial drug and was analysed by the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to 38 weeks
    End point values
    		 Lonapegsomatropin Placebo Somatropin
    Number of subjects analysed
    89
    84
    86
    Units: subjects
        TEAEs
    64
    55
    63
        Serious TEAEs
    4
    1
    6
        TEAE Leading to Study Discontinuation
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of the informed consent form (ICF) to up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
    Adverse event reporting additional description
    Analysis was performed on safety population that included all randomised subjects who received any amount of trial drug and was analysed by the actual treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Lonapegsomatropin
    Reporting group description
    		 Subjects received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.

    Reporting group title
    Somatropin
    Reporting group description
    		 Subjects received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.

    Serious adverse events
    		 Lonapegsomatropin Placebo Somatropin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 89 (4.49%)
    1 / 84 (1.19%)
    6 / 86 (6.98%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Coronavirus pneumonia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lonapegsomatropin Placebo Somatropin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 89 (32.58%)
    47 / 84 (55.95%)
    28 / 86 (32.56%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 89 (7.87%)
    9 / 84 (10.71%)
    5 / 86 (5.81%)
         occurrences all number
    13
    11
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 89 (8.99%)
    8 / 84 (9.52%)
    7 / 86 (8.14%)
         occurrences all number
    8
    8
    9
    Infections and infestations
    COVID-19
         subjects affected / exposed
    7 / 89 (7.87%)
    11 / 84 (13.10%)
    6 / 86 (6.98%)
         occurrences all number
    7
    11
    7
    Nasopharyngitis
         subjects affected / exposed
    5 / 89 (5.62%)
    11 / 84 (13.10%)
    6 / 86 (6.98%)
         occurrences all number
    6
    16
    7
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 89 (2.25%)
    8 / 84 (9.52%)
    4 / 86 (4.65%)
         occurrences all number
    2
    10
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2020
    The Protocol was amended in response to comments and recommendations toward clarification on aspects of the trial, from FDA, the Federal Institute for Drugs and Medical Devices (BfArM), Danish Medicines Agency (DKMA), and Pharmaceuticals and Medical Devices Agency (PMDA).
    20 Jul 2021
    The protocol was amended to include remarks from EU authorities, to facilitate patient recruitment and to provide a clearer trial overview.
    02 Jun 2022
    The protocol was amended to update safety including anaphylaxis precautions, prohibited medication, local German requirement and correction of typographic errors. 

    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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