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    Clinical Trial Results:
    A double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly that are responders to octreotide LAR or lanreotide depot (ACROBAT EVOLVE)

    Summary
    EudraCT number
    		 2018-001833-42
    Trial protocol
    		 HU   SK   GR   PL   GB   IT   RO  
    Global end of trial date
    12 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2024
    First version publication date
    27 Sep 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CRN00808-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03729555
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Crinetics Pharmaceuticals, Inc.
    Sponsor organisation address
    6055 Lusk Blvd, San Diego, United States, CA 92121
    Public contact
    Crinetics Clinical Trials, Crinetics Pharmaceuticals, clinicaltrials@crinetics.com
    Scientific contact
    Crinetics Clinical Trials, Crinetics Pharmaceuticals, clinicaltrials@crinetics.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 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1.To determine the efficacy of CRN00808 in acromegaly subjects that are complete responders to parenteral octreotide LAR or lanreotide depot monotherapy; 2.To evaluate the safety and tolerability of CRN00808 in acromegaly subjects; 3.To evaluate the pharmacokinetics (PK) of CRN00808 in acromegaly subjects.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and the Declaration of Helsinki, as well as current ICH GCP guidelines and applicable regulatory requirements
    Background therapy
    		 Inclusion criteria states diagnosis of acromegaly must be controlled on a stable approved dose of octreotide LAR or lanreotide depot
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Dec 2018
    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
    Greece: 1
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Hungary: 3
    Worldwide total number of subjects
    13
    EEA total number of subjects
    6
    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)
    9
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Medically stable adult subjects 18 to 75 years of age, inclusive, with a confirmed acromegaly diagnosis that was controlled on a stable approved dose of octreotide LAR or lanreotide depot. At a minimum, there had to be documentation available of a pituitary tumor and elevated IGF-1 in the past.

    Pre-assignment
    Screening details
    		 Medically stable adult subjects 18 to 75 years of age, with a confirmed acromegaly diagnosis that was controlled on a stable approved dose of octreotide LAR or lanreotide depot. There had to be documentation available of a pituitary tumour and elevated IGF-1 in the past.

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

    Arms
    Arm title
    		 Treatment
    Arm description
    		 During the titration period, the study drug dose was titrated up in a blinded fashion, provided that the current dose was tolerated by the subject and the IGF-1 value at V4/W2 was >0.9×ULN.
    Arm type
    		 Experimental

    Investigational medicinal product name
    paltusotine
    Investigational medicinal product code
    CRN00808
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The Treatment Period started with the first dose of study drug (10 mg for all subjects). Paltusotine (10 mg oral capsule) was administered once daily after an overnight fast of at least 6 hours. At V6/W4, the study drug dose was titrated up in a blinded fashion, provided that the current dose was tolerated by the subject and the IGF-1 value at V4/W2 was >0.9×ULN. Dose increases in 10 mg increments were allowed only at the V6/W4 (from 10 mg to 20 mg) and V9/W7 (from 10 mg to 20 mg, or from 20 mg to 30 mg) visits. No further up-titration was allowed. The daily dose did not exceed 30 mg.

    Number of subjects in period 1
    		Treatment
    Started
    13
    Completed
    11
    Not completed
    2
         Consent withdrawn by subject
    1
         Unable to attend visits due to pandemic
    1
    Period 2
    Period 2 title
    Randomised Withdrawal
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Randomised Withdrawal -Treatment with Paltusotine
    Arm description
    		 Eligibility for randomization into the RWP was made based on information at the V10/W8 and V11/W10. To be eligible for randomization, the subject had to have IGF-1 value ≤ULN at V10/W8 and an Investigator determination at V11/W10 that the subject tolerated the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    paltusotine
    Investigational medicinal product code
    CRN00808
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The subject administered paltusotine (oral capsule) once daily at the dose level tolerated at the end of the treatment period (10 mg, 20 mg or 30 mg). The daily dose did not exceed 30 mg.

    Arm title
    		 Randomised Withdrawal - Placebo
    Arm description
    		 Eligibility for randomization into the RWP was made based on information at the V10/W8 and V11/W10. To be eligible for randomization, the subject had to have IGF-1 value ≤ULN at V10/W8 and an Investigator determination at V11/W10 that the subject tolerated the study drug. The subjects were randomized at V11/W10 in a blinded manner to be switched to a placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match paltusotine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match paltusotine was administered once daily for the duration of the randomised withdrawal period

    Number of subjects in period 2 [1]
    		Randomised Withdrawal -Treatment with Paltusotine Randomised Withdrawal - Placebo
    Started
    3
    4
    Completed
    3
    4
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 7 subjects were enrolled in RWP, 6 were not, due to IGF-1 (n=4), discontinuation (n=1), and other (n=1). No subjects discontinued due to tolerability.
    Period 3
    Period 3 title
    Not Randomised in Withdrawal Study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Arm title
    		 Treatment (not randomised)
    Arm description
    		 Subjects not eligible for randomisation into the RWP were allowed to stay in the study and continue a study drug dose that was tolerated until the subject completed all study visits or until criteria to resume standard acromegaly therapy and discontinuation from the study were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    paltusotine
    Investigational medicinal product code
    CRN00808
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered paltusotine (oral capsule) once daily at the dose tolerated at the end of the titration/treatment period (10 mg, 20 mg or 30 mg). The daily dose did not exceed 30 mg.

    Number of subjects in period 3 [2]
    		Treatment (not randomised)
    Started
    6
    Completed
    6
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 7 subjects were enrolled in RWP, 6 were not, due to IGF-1 (n=4), discontinuation (n=1), and other (n=1). No subjects discontinued due to tolerability.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 During the titration period, the study drug dose was titrated up in a blinded fashion, provided that the current dose was tolerated by the subject and the IGF-1 value at V4/W2 was >0.9×ULN.

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.5 ( 13.76 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 7 7
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 3
        Not Hispanic or Latino
    		 10 10
        Unknown
    		 0 0
    Race
    Units: Subjects
        White
    		 12 12
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Black or African American
    		 0 0
        Native Hawaiian or Other Pacific
    		 0 0
        Islander
    		 0 0
        Other
    		 1 1
    UGT1A1 Genotype
    Units: Subjects
        *1/*1
    		 5 5
        *1/*80
    		 5 5
        *80/*80
    		 2 2
        Not reported
    		 1 1
    UGT1A1 Phenotype
    Units: Subjects
        Normal Metabolizer
    		 5 5
        Intermediate Metabolizer
    		 5 5
        Poor Metabolizer
    		 2 2
        Not reported
    		 1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 171.02 ( 13.748 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.97 ( 18.088 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.52 ( 4.903 ) -
    Ring Size
    Units: mm
        arithmetic mean (standard deviation)
    		 12.8 ( 3.63 ) -
    Subject analysis sets

    Subject analysis set title
    ITT Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who received at least one dose of the study drug

    Subject analysis set title
    mITT Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects from the ITT analysis set who were randomised into the RWP

    Subject analysis sets values
    		 ITT Analysis Set mITT Analysis Set
    Number of subjects
    13
    7
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    9
    5
        From 65-84 years
    4
    2
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.5 ( 13.76 )
    50 ( 15.41 )
    Gender categorical
    Units: Subjects
        Female
    6
    4
        Male
    7
    3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    3
    1
        Not Hispanic or Latino
    10
    6
        Unknown
    0
    0
    Race
    Units: Subjects
        White
    12
    7
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Black or African American
    0
    0
        Native Hawaiian or Other Pacific
    0
    0
        Islander
    0
    0
        Other
    1
    0
    UGT1A1 Genotype
    Units: Subjects
        *1/*1
    5
    3
        *1/*80
    5
    3
        *80/*80
    2
    1
        Not reported
    1
    UGT1A1 Phenotype
    Units: Subjects
        Normal Metabolizer
    5
    3
        Intermediate Metabolizer
    5
    3
        Poor Metabolizer
    2
    1
        Not reported
    1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    171.02 ( 13.748 )
    173.83 ( 15.092 )
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    80.97 ( 18.088 )
    82.63 ( 16.230 )
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.52 ( 4.903 )
    26.52 ( 2.236 )
    Ring Size
    Units: mm
        arithmetic mean (standard deviation)
    12.8 ( 3.63 )
    14.7 ( 3.88 )

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 During the titration period, the study drug dose was titrated up in a blinded fashion, provided that the current dose was tolerated by the subject and the IGF-1 value at V4/W2 was >0.9×ULN.
    Reporting group title
    Randomised Withdrawal -Treatment with Paltusotine
    Reporting group description
    		 Eligibility for randomization into the RWP was made based on information at the V10/W8 and V11/W10. To be eligible for randomization, the subject had to have IGF-1 value ≤ULN at V10/W8 and an Investigator determination at V11/W10 that the subject tolerated the study drug.

    Reporting group title
    Randomised Withdrawal - Placebo
    Reporting group description
    		 Eligibility for randomization into the RWP was made based on information at the V10/W8 and V11/W10. To be eligible for randomization, the subject had to have IGF-1 value ≤ULN at V10/W8 and an Investigator determination at V11/W10 that the subject tolerated the study drug. The subjects were randomized at V11/W10 in a blinded manner to be switched to a placebo.
    Reporting group title
    Treatment (not randomised)
    Reporting group description
    		 Subjects not eligible for randomisation into the RWP were allowed to stay in the study and continue a study drug dose that was tolerated until the subject completed all study visits or until criteria to resume standard acromegaly therapy and discontinuation from the study were met.

    Subject analysis set title
    ITT Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who received at least one dose of the study drug

    Subject analysis set title
    mITT Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects from the ITT analysis set who were randomised into the RWP

    Primary: The proportion of randomized subjects who met responder criteria at week 13

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    End point title
    		 The proportion of randomized subjects who met responder criteria at week 13 [1]
    End point description
    Responder criteria was based on the mean of two consecutive IGF-1 measurements ≤ULN at Week 13 (visit 13 and visit 14). CRN00808 and placebo was compared for the mITT Analysis Set on change from RWP Baseline/Week 10 to Week 13 using a rank ANCOVA model including fixed effects for randomization strata and treatment, and with the ranked RWP Baseline/Week 10 value includedas a covariate. The Hodges-Lehman estimate of the median treatment difference with associated 95% CI was calculated. p value = 0.6203
    End point type
    Primary
    End point timeframe
    Week 13
    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: Please refer to the endpoint description for details of statistical analyses
    End point values
    		 Randomised Withdrawal -Treatment with Paltusotine Randomised Withdrawal - Placebo
    Number of subjects analysed
    3
    4
    Units: Percentage of responders
        number (confidence interval 95%)
    66.7 (9.4 to 99.2)
    25.0 (0.6 to 80.6)
    No statistical analyses for this end point

    Secondary: Change in IGF-1 between Week 10 and Week 13

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    End point title
    		 Change in IGF-1 between Week 10 and Week 13
    End point description
    End point type
    Secondary
    End point timeframe
    Between RWP week 10 and RWP week 13
    End point values
    		 Randomised Withdrawal -Treatment with Paltusotine Randomised Withdrawal - Placebo
    Number of subjects analysed
    3
    4
    Units: Percent change in IGF1 x ULN
        arithmetic mean (standard deviation)
    4.04 ( 5.064 )
    48.17 ( 41.408 )
    No statistical analyses for this end point

    Secondary: Change in growth hormone (GH) levels between Week 8 and Week 13

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    End point title
    		 Change in growth hormone (GH) levels between Week 8 and Week 13
    End point description
    End point type
    Secondary
    End point timeframe
    From RWP baseline (week 8) to RWP week 13
    End point values
    		 mITT Analysis Set
    Number of subjects analysed
    7
    Units: precent change in GH
        number (confidence interval 95%)
    40.6 (-361.6 to 106.5)
    No statistical analyses for this end point

    Secondary: Change in symptoms of acromegaly as measured by total Acromegaly symptom diary (ASD) score between Week 10 and Week 13

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    End point title
    		 Change in symptoms of acromegaly as measured by total Acromegaly symptom diary (ASD) score between Week 10 and Week 13
    End point description
    End point type
    Secondary
    End point timeframe
    From RWP week 10 to RWP week 13
    End point values
    		 mITT Analysis Set
    Number of subjects analysed
    3
    Units: Difference in total ASD score change
        median (confidence interval 95%)
    -1.1 (-4.3 to 1.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of participation for each subject after obtaining a signed informed consent was up to 23 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Safety analysis set/titration period
    Reporting group description
    		 All participants who received a dose of Paltusotine during the titration period

    Reporting group title
    Randomised withdrawal period- Paltusotine
    Reporting group description
    		 Adverse events reported during the randomised withdrawal period by those receiving Paltusotine treatment during the randomised withdrawal stage

    Reporting group title
    Randomised withdrawal period- Placebo
    Reporting group description
    		 Adverse events reported during the randomised withdrawal period by those receiving Paltusotine treatment

    Reporting group title
    Total Paltusotine
    Reporting group description
    		 Includes those not eligible for the trial randomised withdrawal period were allowed to stay in the study and continue a study drug dose that was tolerated until the subject completed all study visits

    Serious adverse events
    		 Safety analysis set/titration period Randomised withdrawal period- Paltusotine Randomised withdrawal period- Placebo Total Paltusotine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety analysis set/titration period Randomised withdrawal period- Paltusotine Randomised withdrawal period- Placebo Total Paltusotine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 13 (61.54%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    10 / 13 (76.92%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    3
    1
    0
    4
    Paraesthesia
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    0
    1
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    3
    Peripheral swelling
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    3 / 13 (23.08%)
         occurrences all number
    2
    0
    1
    3
    Pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    1
    Back pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    0
    0
    2
    COVID-19
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2019
    Summary of changes made in amendment 1: - Added patient-facing quality of life and acromegaly symptom scales with corresponding adjustments to the study secondary/exploratory endpoints. The purpose of these scales was to collect patient-reported data to further the development of a scale to assess the symptom burden of acromegaly. - Added stopping criteria for cardiac, liver, and other clinical conditions. - Changed to pre-dose collection of IGF-1 samples for endpoint-related visits. - Modification of certain inclusion/exclusion criteria and additional administrative updates.
    06 Jun 2019
    Summary of changes made in amendment 2: - The demotion of a Secondary Endpoint to an Exploratory Endpoint (Proportion of subjects who achieved serum GH <5.0 ng/mL at W13). - Certain visits where minimal study procedures were performed were changed to Phone Call visits instead of site visits to reduce visit burden on subjects. - Changes to IGF-1 sample collection and titration criteria were made due to the change in visit structure of certain visits from site to Phone Visits. - Included the option to allow for certain visits to be conducted by mobile home health professionals at the option of the principal investigator and subject. These home health assessments were performed by qualified and trained staff and under the supervision of each site principal investigator, with activities specifically delegated by the principal investigator. - Reduction in collection time points of the ASD. - Changes to ASD scale question, wording, and scoring of the total ASD. - Subjects with prior radiation therapy in some circumstances were allowed to enrol in the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Mar 2020
    The Sponsor halted enrollment in the study early due to business reasons; subjects already enrolled in this study at the time of enrollment cessation continued until study completion.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to small sample size, a number of endpoints were listed but not summarised.
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    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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