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    Clinical Trial Results:
    A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency

    Summary
    EudraCT number
    		 2021-004313-39
    Trial protocol
    		 GR   SK   FR   ES   DE   IT   RO  
    Global end of trial date
    23 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2026
    First version publication date
    03 Jan 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TCH-306 EXT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05171855
    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
    02 Sep 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of once-weekly lonapegsomatropin in adults with growth hormone deficiency (GHD) previously treated in trial TCH-306 or switching from commercially available somatropin treatment (Japan only).
    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
    16 Dec 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
    Armenia: 5
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Georgia: 21
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Türkiye: 10
    Country: Number of subjects enrolled
    Ukraine: 27
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 41
    Country: Number of subjects enrolled
    Japan: 28
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 9
    Country: Number of subjects enrolled
    Italy: 3
    Worldwide total number of subjects
    233
    EEA total number of subjects
    75
    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)
    233
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study TCH-306 EXT enrolled subjects who had completed treatment in TCH-306 (NCT04615273/2021-004313-39). In Japan only, subjects switched from commercially available somatropin therapy (reported separately).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lonapegsomatropin/Lonapegsomatropin
    Arm description
    		 Subjects who had completed treatment with lonapegsomatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lonapegsomatropin
    Investigational medicinal product code
    Other name
    ACP-011
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

    Arm title
    		 Placebo/Lonapegsomatropin
    Arm description
    		 Subjects who had completed treatment with placebo in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lonapegsomatropin
    Investigational medicinal product code
    Other name
    ACP-011
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

    Arm title
    		 Somatropin/Lonapegsomatropin
    Arm description
    		 Subjects who had completed treatment with somatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lonapegsomatropin
    Investigational medicinal product code
    Other name
    ACP-011
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

    Number of subjects in period 1 [1]
    		Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Started
    73
    73
    74
    Completed
    67
    69
    66
    Not completed
    6
    4
    8
         Consent withdrawn by subject
    2
    -
    5
         Physician decision
    1
    -
    -
         Adverse event, non-fatal
    2
    4
    2
         Death
    1
    -
    -
         Unspecified
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Subjects in the commercial switch arm (Japan only) are reported separately.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lonapegsomatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with lonapegsomatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Placebo/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with placebo in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Somatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with somatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group values
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin Total
    Number of subjects
    		 73 73 74 220
    Age categorical
    Units: Subjects
        < 30 years
    		 10 13 14 37
        >= 30 to <= 60 years
    		 53 51 52 156
        > 60 years
    		 10 9 8 27
    Gender categorical
    Units: Subjects
        Female
    		 37 32 31 100
        Male
    		 36 41 43 120
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 3 5 11
        Not Hispanic or Latino
    		 68 69 67 204
        Unknown or Not Reported
    		 2 1 2 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 1
        Asian
    		 9 7 8 24
        Black or African American
    		 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 59 62 64 185
        Other
    		 5 3 1 9

    End points

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    End points reporting groups
    Reporting group title
    Lonapegsomatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with lonapegsomatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Placebo/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with placebo in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Somatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with somatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Primary: 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 [1]
    End point description
    An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant 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 was any untoward medical occurrence at any dose that met any of the following criteria: resulted in death; was life threatening; required or prolonged inpatient hospitalisation; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed or was considered a significant medical event by the investigator. Analysis was performed on all subjects who were exposed to any amount of the trial drug in the study TCH306 EXT.
    End point type
    Primary
    End point timeframe
    Up to 52 Weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis data was reported for this endpoint as the endpoint was descriptive in nature.
    End point values
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Number of subjects analysed
    73
    73
    74
    Units: subjects
        TEAEs
    48
    52
    45
        Serious TEAEs
    7
    4
    5
        TEAE Leading to Study Discontinuation
    2
    4
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Trunk Percent Fat at Week 52

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    End point title
    		 Change From Baseline in Trunk Percent Fat at Week 52
    End point description
    Trunk percent fat was assessed by dual-energy X-ray absorptiometry. Analysis was performed on safety analysis set. Here, "number analysed" = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline main trial to week 52 (extension period)
    End point values
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Number of subjects analysed
    67
    69
    66
    Units: percent fat
        least squares mean (confidence interval 95%)
    -1.21 (-2.41 to -0.01)
    -1.60 (-2.35 to -0.86)
    -1.11 (-2.05 to -0.17)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Trunk Fat Mass at Week 52

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    End point title
    		 Change From Baseline in Trunk Fat Mass at Week 52
    End point description
    Trunk fat mass was assessed by dual-energy X-ray absorptiometry. Analysis was performed on safety analysis set. Here, "number analysed" = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline main trial to week 52 (extension period)
    End point values
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Number of subjects analysed
    67
    69
    66
    Units: kilogram(s)
        least squares mean (confidence interval 95%)
    0.15 (-0.47 to 0.77)
    -0.16 (-0.63 to 0.31)
    -0.00 (-0.53 to 0.53)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Body Lean Mass at Week 52

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    End point title
    		 Change From Baseline in Total Body Lean Mass at Week 52
    End point description
    Total body lean mass was assessed by dual-energy X-ray absorptiometry. Analysis was performed on safety analysis set. Here, "number analysed" = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline main trial to week 52 (extension period)
    End point values
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Number of subjects analysed
    67
    69
    66
    Units: kilogram(s)
        least squares mean (confidence interval 95%)
    2.26 (1.47 to 3.05)
    1.97 (1.15 to 2.80)
    2.07 (1.21 to 2.94)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of the study drug up to Week 52
    Adverse event reporting additional description
    Analysis was performed on all subjects who were exposed to any amount of the trial drug in the study TCH306 EXT.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Lonapegsomatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with lonapegsomatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Placebo/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with placebo in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Reporting group title
    Somatropin/Lonapegsomatropin
    Reporting group description
    		 Subjects who had completed treatment with somatropin in TCH-306 were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

    Serious adverse events
    		 Lonapegsomatropin/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 73 (9.59%)
    4 / 73 (5.48%)
    5 / 74 (6.76%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pituitary tumour benign
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Uterine leiomyoma
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (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
    Nervous system disorders
    Cerebral cyst
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sarcoidosis of lymph node
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (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
    Reproductive system and breast disorders
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    0 / 74 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary mass
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Endocrine disorders
    Adrenocortical insufficiency acute
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Hyperparathyroidism
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Enterocolitis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Gastritis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Infected seroma
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 74 (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
    Sepsis
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 73 (0.00%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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/Lonapegsomatropin Placebo/Lonapegsomatropin Somatropin/Lonapegsomatropin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 73 (34.25%)
    29 / 73 (39.73%)
    21 / 74 (28.38%)
    Investigations
    Haematocrit increased
         subjects affected / exposed
    0 / 73 (0.00%)
    5 / 73 (6.85%)
    1 / 74 (1.35%)
         occurrences all number
    0
    5
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 73 (0.00%)
    6 / 73 (8.22%)
    4 / 74 (5.41%)
         occurrences all number
    0
    7
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 73 (0.00%)
    4 / 73 (5.48%)
    1 / 74 (1.35%)
         occurrences all number
    0
    5
    1
    Headache
         subjects affected / exposed
    5 / 73 (6.85%)
    5 / 73 (6.85%)
    4 / 74 (5.41%)
         occurrences all number
    6
    5
    6
    Oedema peripheral
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 73 (5.48%)
    0 / 74 (0.00%)
         occurrences all number
    1
    8
    0
    Pyrexia
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    4 / 74 (5.41%)
         occurrences all number
    1
    0
    6
    Influenza
         subjects affected / exposed
    0 / 73 (0.00%)
    6 / 73 (8.22%)
    0 / 74 (0.00%)
         occurrences all number
    0
    10
    0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 73 (6.85%)
    1 / 74 (1.35%)
         occurrences all number
    2
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 73 (9.59%)
    7 / 73 (9.59%)
    8 / 74 (10.81%)
         occurrences all number
    11
    11
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 73 (6.85%)
    1 / 74 (1.35%)
         occurrences all number
    4
    11
    1
    Back pain
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 73 (6.85%)
    2 / 74 (2.70%)
         occurrences all number
    3
    5
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 73 (5.48%)
    4 / 73 (5.48%)
    2 / 74 (2.70%)
         occurrences all number
    4
    4
    2
    Nasopharyngitis
         subjects affected / exposed
    12 / 73 (16.44%)
    6 / 73 (8.22%)
    2 / 74 (2.70%)
         occurrences all number
    17
    10
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2022
    The rationale of this protocol version was the introduction of two additional exclusion criteria in the event a subject enrolled in Study TCH-306 develops new onset renal and/or hepatic impairment in all countries.
    16 Jun 2022
    The rationale of this protocol version was to update safety including anaphylaxis precautions, prohibited medication, precaution if MRI/CT scan were performed at the same visit as DXA scan 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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