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    Clinical Trial Results:
    A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

    Summary
    EudraCT number
    		 2019-001191-11
    Trial protocol
    		 DE   HU   GB   PL   ES   GR   IT  
    Global end of trial date
    02 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HS-18-633
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04076462
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Camurus
    Sponsor organisation address
    Rydbergs torg 4, Lund, Sweden, 224 84
    Public contact
    VP Clinical Development, Camurus AB, 46 462865730, info@camurus.com
    Scientific contact
    VP Clinical Development, Camurus AB, 46 462865730, info@camurus.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 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the superiority of CAM2029 compared to placebo in biochemical response for IGF 1
    Protection of trial subjects
    Patients in the trial were regularly and carefully monitored for AEs. Parameters that were monitored regularly included vital signs, hematology laboratory assessments, blood chemistry (including renal and liver function and thyroid hormones), urinalysis, electrocardiogram, gallbladder ultrasound, local tolerability, and assessments for other potential AEs. Blood samples were also taken for qualification and quantification of antioctreotide antibodies to assess for potential immunogenicity. In addition, the protocol provided specific guidance for dose adjustment/IMP discontinuation and safety follow-up for adverse drug reactions, liver toxicity (increased liver enzymes), and QT prolongation. Patients were discontinued from treatment with the blinded investigational medicinal product and switched to rescue with the standard of care in case they experienced worsening of signs and symptoms of acromegaly together with an increase in the levels of IGF-1 to ≥1.3xULN at two consecutive visits. During the trial, self- or partner-administration of CAM2029 in the abdomen or thigh was allowed after appropriate training and under the supervision of adequately trained trial personnel. The patients or their partners were, however, not permitted to administer CAM2029/placebo on their own until they had been appropriately trained and judged capable of doing so by the trial personnel.
    Background therapy
    		 No specific background therapy was defined for the trial. Patients were eligible and enrolled, if they were biochemically controlled on treatment with long-acting somatostatin receptor ligands (octreotide LAR or lanreotide ATG). The first dose of CAM2029 or placebo on Day 1 in the Double-blind Treatment Phase was given 4 weeks (±3 days) after the last dose of octreotide LAR or lanreotide ATG.
    Evidence for comparator
    		 Placebo was used as a comparator.
    Actual start date of recruitment
    19 Aug 2019
    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
    Türkiye: 15
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    72
    EEA total number of subjects
    24
    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)
    53
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 33 clinical trial sites in 9 countries randomized patients into the trial. The first patient was enrolled on 19 August 2019, and the last patient completed the trial on 02 May 2023.

    Pre-assignment
    Screening details
    		 Patients with the diagnosis of acromegaly treated with a stable dose of octreotide LAR or lanreotide ATG were screened.

    Period 1
    Period 1 title
    Double-blind Treatment Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor
    Blinding implementation details
    The blinding was supported by the placebo product being identical to the CAM2029 product regarding appearance, volume, and viscosity of the solution. The randomized treatment assignment, and all individual IGF-1, GH, PK, and immunogenicity results remained concealed to patients, Investigators, and the trial team until the trial was completed and a decision was made to unblind. IGF-1 results were monitored by an independent reader during the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CAM2029
    Arm description
    		 Active treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octreotide subcutaneous depot
    Investigational medicinal product code
    CAM2029
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CAM2029 was administered with a ready-to-use pre-filled syringe once monthly for 24 weeks. The patients randomized to CAM2029 received 20 mg CAM2029 on Day 1 regardless of their previous dose of octreotide LAR or lanreotide ATG. If needed, doses of IMP could be down-titrated from 20 mg to 10 mg once monthly for safety/tolerability reasons.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered with a ready-to-use pre-filled syringe with a volume of 0.5 or 1.0 mL, once monthly for 24 weeks. The volumes corresponded to 20 mg CAM2029 (for 1.0 mL) and 10 mg CAM2029 (for 0.5 mL).

    Number of subjects in period 1
    		CAM2029 Placebo
    Started
    48
    24
    Completed
    46
    24
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CAM2029
    Reporting group description
    		 Active treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 CAM2029 Placebo Total
    Number of subjects
    		 48 24 72
    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)
    		 34 19 53
        From 65-84 years
    		 14 5 19
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.0 ( 11.2 ) 52.0 ( 15.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 12 40
        Male
    		 20 12 32

    End points

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    End points reporting groups
    Reporting group title
    CAM2029
    Reporting group description
    		 Active treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Intention-to-treat (ITT) Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT included all patients randomized to a treatment arm.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set included all patients who received at least one dose of IMP.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients in the ITT analysis set who received at least one dose of the randomized IMP.

    Primary: Proportion of Patients With Mean IGF-1 Levels ≤1x ULN at Week 22/24

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    End point title
    		 Proportion of Patients With Mean IGF-1 Levels ≤1x ULN at Week 22/24
    End point description
    If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable (or endpoint) of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if he/she discontinued treatment with IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. Note that the numbers presented in the table with End point values represent the estimated number of responders based on imputation of data, and not the proportion of responders. The mean proportion of responders was 72.2% in the CAM2029 treatment arm and 37.5% in the placebo treatment arm.
    End point type
    Primary
    End point timeframe
    At Week 22 and Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: Estimated number of patients
        number (not applicable)
    34.7
    9.0
    Statistical analysis title
    		 Difference in proportions
    Statistical analysis description
    Cochran-Mantel-Haenszel-type common difference in proportions across strata, stratified by prior treatment (octreotide LAR or lanreotide ATG).
    Comparison groups
    Placebo v CAM2029
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0018 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    34.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 57.9
    Notes
    [1] - Upper-tailed p-value

    Secondary: Proportion of Patients With Mean GH Levels <2.5 μg/L at Week 24

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    End point title
    		 Proportion of Patients With Mean GH Levels <2.5 μg/L at Week 24
    End point description
    Proportion of Patients with Mean GH Levels <2.5 ug/L at Week 24 in the ITT analysis set. Note that the numbers presented in the table with End point values represent the estimated number of patients based on imputation of data, and not the proportion of patients.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: Patients
    42
    20
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Mean GH Levels <1.0 μg/L at Week 24

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    End point title
    		 Proportion of Patients With Mean GH Levels <1.0 μg/L at Week 24
    End point description
    Proportion of Patients with Mean GH Levels <1.0 ug/L at Week 24 in the ITT analysis set. Note that the numbers presented in the table with End point values represent the estimated number of patients based on imputation of data, and not the proportion of patients.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: Patients
        number (not applicable)
    28.8
    9.0
    No statistical analyses for this end point

    Secondary: Patients/partners competent to administer CAM2029 or placebo

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    End point title
    		 Patients/partners competent to administer CAM2029 or placebo
    End point description
    Patients/partners declared competent out of those choosing to self-inject (percentage of patients/partners choosing to self-inject) in the ITT analysis set. Note that the numbers presented in the table with End point values represent the number of patients who were declared competent and not the proportion of patients.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    35
    22
    Units: Patients
    32
    20
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 24/EOT in TSQM convenience domain scores

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    End point title
    		 Change from baseline to Week 24/EOT in TSQM convenience domain scores
    End point description
    Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scores in the convenience domain from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The TSQM domain scores ranged from 0 to 100, where higher scores indicated better satisfaction. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline TSQM scores represented the patients’ satisfaction with their previous treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    13.85 (9.45 to 18.25)
    9.90 (4.06 to 15.75)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 10.83

    Secondary: Change from baseline to Week 24/EOT in TSQM effectiveness domain scores

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    End point title
    		 Change from baseline to Week 24/EOT in TSQM effectiveness domain scores
    End point description
    Change in TSQM scores in the effectiveness domain from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The TSQM domain scores ranged from 0 to 100, where higher scores indicated better satisfaction. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline TSQM scores represented the patients’ satisfaction with their previous treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    -2.72 (-9.94 to 4.51)
    -3.11 (-12.09 to 5.86)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 11.6

    Secondary: Change from baseline to Week 24/EOT in TSQM global satisfaction domain scores

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    End point title
    		 Change from baseline to Week 24/EOT in TSQM global satisfaction domain scores
    End point description
    Change in TSQM scores in the global satisfaction domain from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The TSQM domain scores ranged from 0 to 100, where higher scores indicated better satisfaction. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline TSQM scores represented the patients’ satisfaction with their previous treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    0.10 (-7.00 to 7.20)
    -2.77 (-11.60 to 6.06)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.23
         upper limit
    		 13.97

    Secondary: Change from baseline to Week 24/EOT in TSQM side effects scores

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    End point title
    		 Change from baseline to Week 24/EOT in TSQM side effects scores
    End point description
    Change in TSQM scores in the side effects domain from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The TSQM domain scores ranged from 0 to 100, where higher scores indicated better satisfaction. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline TSQM scores represented the patients’ satisfaction with their previous treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    3.37 (-1.95 to 8.69)
    -3.70 (-10.77 to 3.38)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.63
         upper limit
    		 15.76

    Secondary: Patient satisfaction scale score at Week 24/EOT

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    End point title
    		 Patient satisfaction scale score at Week 24/EOT
    End point description
    Patient satisfaction scale scores at Week 24/EOT in the ITT analysis set. Patient satisfaction scores ranged from 1 (much worse) to 5 (much better), where higher scores indicated better satisfaction.
    End point type
    Secondary
    End point timeframe
    At Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        arithmetic mean (confidence interval 95%)
    3.9 (3.6 to 4.2)
    3.4 (2.9 to 3.8)
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 24/EOT in AcroQoL Total Score

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    End point title
    		 Change from baseline to Week 24/EOT in AcroQoL Total Score
    End point description
    Change in Acromegaly Quality of Life Questionnaire (AcroQoL) total score from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The AcroQoL domain scores ranged from 0 to 100, where higher scores indicated better quality of life. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline AcroQoL scores represented the patients’ quality of life while on treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    4.685 (1.510 to 7.861)
    2.237 (-2.246 to 6.721)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.448
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.958
         upper limit
    		 7.853

    Secondary: Change from baseline to Week 24/EOT in AcroQoL Physical Domain Score

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    End point title
    		 Change from baseline to Week 24/EOT in AcroQoL Physical Domain Score
    End point description
    Change in AcroQoL Physical Domain Score from Baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The AcroQoL domain scores ranged from 0 to 100, where higher scores indicated better quality of life. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline AcroQoL scores represented the patients’ quality of life while on treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    3.968 (0.346 to 7.590)
    -1.198 (-6.348 to 3.952)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.166
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.097
         upper limit
    		 11.429

    Secondary: Change from baseline to Week 24/EOT in AcroQoL Psychological Domain Total Score

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    End point title
    		 Change from baseline to Week 24/EOT in AcroQoL Psychological Domain Total Score
    End point description
    Change in AcroQoL Psychological Domain Total Score from baseline to Week 24/EOT by treatment arm: ANCOVA model within a pattern-mixture model framework in the ITT analysis set. The AcroQoL domain scores ranged from 0 to 100, where higher scores indicated better quality of life. In the ANCOVA analysis of change from baseline to Week 24/EOT, the baseline AcroQoL scores represented the patients’ quality of life while on treatment with standard of care (octreotide LAR or lanreotide ATG).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 24 / End of treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: score
        least squares mean (confidence interval 95%)
    5.054 (1.684 to 8.424)
    4.433 (-0.313 to 9.178)
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.621
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.147
         upper limit
    		 6.39

    Secondary: Change from baseline to Week 24 in EQ-5D-5L Visual Analog Scale Score

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    End point title
    		 Change from baseline to Week 24 in EQ-5D-5L Visual Analog Scale Score
    End point description
    Change in EQ-5D-5L visual analogue scale (VAS) score from baseline to Week 24/EOT in the ITT analysis set. The EQ-5D-5L VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
    End point type
    Secondary
    End point timeframe
    From Day 1 until Week 24 / End of Treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    42
    21
    Units: score
        arithmetic mean (confidence interval 95%)
    0.9 (-2.4 to 4.3)
    0.1 (-5.8 to 6.0)
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 24 in EQ-5D-5L Index Value

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    End point title
    		 Change from baseline to Week 24 in EQ-5D-5L Index Value
    End point description
    Change in EQ-5D-5L Index Value from baseline to Week 24/EOT in the ITT analysis set. An EQ-5D-5L Index Value of 0 represented death and 1 represented full health. Values below 0 can occur.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Week 24 / End of Treatment
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    42
    21
    Units: score
        arithmetic mean (confidence interval 95%)
    -0.009 (-0.059 to 0.040)
    0.012 (-0.029 to 0.052)
    No statistical analyses for this end point

    Secondary: Plasma octreotide concentrations over time

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    End point title
    		 Plasma octreotide concentrations over time [2]
    End point description
    Descriptive statistics of plasma octreotide concentration values in the full analysis set.
    End point type
    Secondary
    End point timeframe
    From pre-dose until Week 24 / End of treatment
    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: Octreotide as a pharmacokinetic value is only reported for the active arm. In the table the pre-dose value at Week 24 is presented.
    End point values
    		 CAM2029
    Number of subjects analysed
    47
    Units: ng/mL
        arithmetic mean (standard deviation)
    1.049 ( 0.970 )
    Attachments
    		 Mean octreotide plasma concentrations over time
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Mean IGF-1 Levels ≤1x ULN at Week 22/24, Irrespective of IMP Dose

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    End point title
    		 Proportion of Patients With Mean IGF-1 Levels ≤1x ULN at Week 22/24, Irrespective of IMP Dose
    End point description
    This is the key secondary endpoint I. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable (or endpoint) of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if he/she discontinued treatment with IMP prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. ULN was based on the patient's sex and age at screening. Note that the numbers presented in the table with End point values represent the estimated number of responders based on imputation of data, and not the proportion of responders. The mean proportion of responders was 72.2% in the CAM2029 arm and 37.5% in the placebo arm.
    End point type
    Secondary
    End point timeframe
    At Week 22 and Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: Estimated number of patients
        number (not applicable)
    34.7
    9.0
    Statistical analysis title
    		 Difference in proportions
    Statistical analysis description
    Cochran-Mantel-Haenszel-type common difference in proportions across strata, stratified by prior treatment (octreotide LAR or lanreotide ATG).
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0018 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    34.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 57.9
    Notes
    [3] - Upper-tailed p-value

    Secondary: Proportion of Patients With Mean IGF-1 levels ≤1×ULN at Week 22/24 and Mean GH Levels <2.5 μg/L at Week 24

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    End point title
    		 Proportion of Patients With Mean IGF-1 levels ≤1×ULN at Week 22/24 and Mean GH Levels <2.5 μg/L at Week 24
    End point description
    This is the key secondary endpoint II. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable (or endpoint) of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if he/she discontinued treatment with IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. Note that the numbers presented in the table with End point values represent the estimated number of responders based on imputation of data, and not the proportion of responders. The mean proportion of responders was 70.0% in the CAM2029 arm and 37.5% in the placebo arm.
    End point type
    Secondary
    End point timeframe
    At Week 22 and Week 24
    End point values
    		 CAM2029 Placebo
    Number of subjects analysed
    48
    24
    Units: Estimated number of patients
        number (not applicable)
    33.6
    9.0
    Statistical analysis title
    		 Difference in proportions
    Comparison groups
    CAM2029 v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0035
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    32.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.8
         upper limit
    		 55.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were assessed from the time of informed consent until completion of all trial procedures and discharge from the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    CAM2029
    Reporting group description
    		 Safety analysis set.

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 CAM2029 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 24 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CAM2029 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 47 (76.60%)
    19 / 24 (79.17%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    12 / 47 (25.53%)
    5 / 24 (20.83%)
         occurrences all number
    19
    7
    Injection site swelling
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 24 (8.33%)
         occurrences all number
    10
    2
    Injection site mass
         subjects affected / exposed
    3 / 47 (6.38%)
    5 / 24 (20.83%)
         occurrences all number
    8
    12
    Injection site pruritus
         subjects affected / exposed
    7 / 47 (14.89%)
    1 / 24 (4.17%)
         occurrences all number
    9
    1
    Injection site induration
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 24 (12.50%)
         occurrences all number
    6
    4
    Injection site pain
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 24 (12.50%)
         occurrences all number
    4
    7
    Injection site nodule
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 24 (4.17%)
         occurrences all number
    5
    4
    Fatigue
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
         occurrences all number
    4
    1
    Injection site rash
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Leukopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
         occurrences all number
    6
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 24 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 47 (17.02%)
    2 / 24 (8.33%)
         occurrences all number
    10
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 24 (12.50%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2020
    - Deletion of the GH cycle assessment at Week -2; - Addition of option for patients who were screen failures in HS-19-647 to be screened for HS-18-633; - Clarifications about the definition of the primary estimand and the responder definition for the secondary endpoints; - Update of the enrollment criteria to enable the inclusion of patients with Gilbert syndrome and to adjust the diagnosis of acromegaly to clinical practice.
    31 Jan 2023
    - Upgrade of the TSQM, ACroQoL, and EQ-5D-5L endpoints from exploratory to secondary; - Update of the text describing how to handle PDs due to COVID-19; - Implement recommendations from the US FDA on the statistical analysis: - Addition and/or update of sensitivity, supportive, and subgroup analyses of the primary and key secondary endpoints; - Update of the primary estimand definition; - Usage of ITT analysis set for the efficacy analysis.

    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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