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    Clinical Trial Results:
    A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)

    Summary
    EudraCT number
    		 2020-001202-32
    Trial protocol
    		 DE   CZ   FR   NO   BE   HU   PL   SE   DK   IT   ES  
    Global end of trial date
    22 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2025
    First version publication date
    11 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TA799-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04627025
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VectivBio AG
    Sponsor organisation address
    Aeschenvorstadt 36, Basel, Switzerland,
    Public contact
    Clinical Trial Information Desk, VectivBio AG, ClinicalTrialEnquiries@ironwoodpharma.com
    Scientific contact
    Clinical Trial Information Desk, VectivBio AG, ClinicalTrialEnquiries@ironwoodpharma.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
    22 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency
    Protection of trial subjects
    The trial was conducted in compliance with Good Clinical Practice (GCP), the Declaration of Helsinki, and applicable regulatory requirements to ensure the safety, rights, and well-being of all participants. Before enrollment, all subjects provided written informed consent, and the study protocol was approved by Ethics Committees (ECs) and Health Authorities in each participating country. Subjects were monitored throughout the study for adverse events (AEs), serious adverse events (SAEs), and protocol compliance. An independent Data Monitoring Committee (DMC) periodically reviewed safety data to assess potential risks and recommend necessary actions. To minimize risks, eligibility criteria were strictly defined to include only subjects for whom the investigational product was deemed appropriate. Measures were in place to protect vulnerable populations, ensuring confidentiality of personal data and adherence to local data protection laws. Study investigators received comprehensive training on the protocol, safety reporting procedures, and risk mitigation strategies. Any protocol deviations impacting subject safety were documented and reviewed. Throughout the trial, continuous medical oversight was provided, with subjects able to withdraw at any time without consequences to their medical care. Post-study follow-up ensured that any treatment- related concerns were addressed appropriately.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Italy: 6
    Worldwide total number of subjects
    163
    EEA total number of subjects
    103
    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)
    124
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started (first patient screened) on 03 December 2020 and was completed on 22 February 2024 (last patient out). The study was conducted in the EEA (Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Norway, Poland, Spain, Sweden), the United Kingdom, the United States, Argentina, Israel, Japan, South Korea, and Taiwan.

    Pre-assignment
    Screening details
    		 216 subjects were screened, and 163 subjects were randomized. The screening period included an optimization phase for parenteral support (PS) adjustment and a stabilization phase. 53 subjects failed screening, mainly due to failed PS optimization criteria (39.6%), consent withdrawal (28.3%), or failed PS stability criteria (17.0%).

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    apraglutide
    Investigational medicinal product code
    Other name
    TA799
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Apraglutide was administered as a once-weekly (QW) subcutaneous (SC) injection. Two doses was used based on subject`s weight at the most recent study visit (low dose for subjects with a body weight <50 kg or high dose for subjects with a body weight ≥50 kg).

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered as a once-weekly subcutaneous (SC) injection.

    Number of subjects in period 1
    		Active arm Placebo arm
    Started
    110
    53
    Completed
    104
    51
    Not completed
    6
    2
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    4
    1
         Death
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Reporting group values
    		 Active arm Placebo arm Total
    Number of subjects
    		 110 53 163
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 87 37 124
        From 65-84 years
    		 23 16 39
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 66 26 92
        Male
    		 44 27 71

    End points

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    End points reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Primary: Primary Endpoint: Relative change from baseline in actual weekly parenteral support (PS) volume at Week 24 (overall population)

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    End point title
    		 Primary Endpoint: Relative change from baseline in actual weekly parenteral support (PS) volume at Week 24 (overall population)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Active arm Placebo arm
    Number of subjects analysed
    110
    53
    Units: % change from baseline
        least squares mean (confidence interval 95%)
    -25.5 (-31.6 to -19.4)
    -12.5 (-17.6 to -7.5)
    Statistical analysis title
    		 Primary endpoint statistical analysis
    Comparison groups
    Active arm v Placebo arm
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 mixed effect model repeated measures
    Parameter type
    		 Median difference (final values)
    Point estimate
    -13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.9
         upper limit
    		 -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1

    Secondary: First Key Secondary Endpoint: PS Reduction of At Least 1 Day per Week from Baseline at Week 24 in the Overall Population

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    End point title
    		 First Key Secondary Endpoint: PS Reduction of At Least 1 Day per Week from Baseline at Week 24 in the Overall Population
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 24
    End point values
    		 Active arm Placebo arm
    Number of subjects analysed
    110
    53
    Units: Proportion (%)
        number (confidence interval 95%)
    43.0 (33.6 to 52.5)
    27.5 (15.2 to 39.7)
    Statistical analysis title
    		 Analysis for the first key secondary endpoint
    Comparison groups
    Placebo arm v Active arm
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 30.5

    Secondary: Second Key Secondary Endpoint: Relative Change from Baseline in Actual Weekly PS Volume at Week 24 in the Stoma Subpopulation

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    End point title
    		 Second Key Secondary Endpoint: Relative Change from Baseline in Actual Weekly PS Volume at Week 24 in the Stoma Subpopulation
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 24
    End point values
    		 Active arm Placebo arm
    Number of subjects analysed
    54 [1]
    26 [2]
    Units: % change from baseline
        least squares mean (confidence interval 95%)
    -25.6 (-34.0 to -17.2)
    -7.8 (-14.0 to -1.6)
    Notes
    [1] - Stoma subpopulation
    [2] - Stoma subpopulation
    Statistical analysis title
    		 Analysis for the second key secondary endpoint
    Comparison groups
    Active arm v Placebo arm
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed effect model repeated measures
    Parameter type
    		 Median difference (final values)
    Point estimate
    -17.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.4
         upper limit
    		 -7.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.4

    Secondary: Third Key Secondary Endpoint: PS Reduction of At Least 1 Day per Week from Baseline at Week 48 in the CIC Subpopulation

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    End point title
    		 Third Key Secondary Endpoint: PS Reduction of At Least 1 Day per Week from Baseline at Week 48 in the CIC Subpopulation
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Active arm Placebo arm
    Number of subjects analysed
    56 [3]
    27 [4]
    Units: % of subjects
        number (confidence interval 95%)
    51.8 (38.0 to 65.3)
    44.4 (25.5 to 64.7)
    Notes
    [3] - CIC subpopulation
    [4] - CIC subpopulation
    Statistical analysis title
    		 Analysis for the third key secondary endpoint
    Comparison groups
    Active arm v Placebo arm
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.348 [5]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.4
         upper limit
    		 29.8
    Notes
    [5] - A numerically higher proportion of subjects in the apraglutide group compared with the placebo group (29 subjects out of 56, 51.8% vs 12 subjects out of 27, 44.4%) in the CIC subpopulation had a PS reduction of at least 1 day per week at Week 48.

    Secondary: Fourth Key Secondary Endpoint: Enteral Autonomy at Week 48 in the CIC Subpopulation

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    End point title
    		 Fourth Key Secondary Endpoint: Enteral Autonomy at Week 48 in the CIC Subpopulation
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to week 48
    End point values
    		 Active arm Placebo arm
    Number of subjects analysed
    56 [6]
    27 [7]
    Units: % of subjects
        number (confidence interval 95%)
    12.5 (5.2 to 24.1)
    7.4 (0.9 to 24.3)
    Notes
    [6] - CIC subpopulation
    [7] - CIC subpopulation
    Statistical analysis title
    		 Analysis for the fourth key secondary endpoint
    Comparison groups
    Active arm v Placebo arm
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.387 [8]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.9
         upper limit
    		 18.5
    Notes
    [8] - A higher proportion of subjects in the apraglutide group compared with the placebo group (7 subjects [12.5%] vs 2 subjects [7.4%]) in the CIC subpopulation reached enteral autonomy at Week 48.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the trial from the time of obtaining informed consent until the last protocol-specific procedure, whether it is the EOT Visit or Early Termination Visit, or a safety follow-up period.
    Adverse event reporting additional description
    None of SAEs were assessed as related to apraglutide. The frequency threshold is applied for the number of affected subjects.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Serious adverse events
    		 Active arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 110 (35.45%)
    17 / 53 (32.08%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related thrombosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vessel puncture site inflammation
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site hypergranulation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 110 (0.91%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolonic fistula
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Purpura
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Vascular device infection
         subjects affected / exposed
    14 / 110 (12.73%)
    5 / 53 (9.43%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (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 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological infection
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic pulmonary embolism
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site infection
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 53 (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
    		 Active arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 110 (89.09%)
    47 / 53 (88.68%)
    Investigations
    Weight decreased
         subjects affected / exposed
    7 / 110 (6.36%)
    3 / 53 (5.66%)
         occurrences all number
    9
    3
    Lipase increased
         subjects affected / exposed
    2 / 110 (1.82%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    C-reactive protein increased
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 53 (5.66%)
         occurrences all number
    1
    4
    Vascular disorders
    Hypotension
         subjects affected / exposed
    6 / 110 (5.45%)
    1 / 53 (1.89%)
         occurrences all number
    7
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 110 (12.73%)
    6 / 53 (11.32%)
         occurrences all number
    25
    19
    Dizziness
         subjects affected / exposed
    6 / 110 (5.45%)
    1 / 53 (1.89%)
         occurrences all number
    7
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 110 (10.00%)
    3 / 53 (5.66%)
         occurrences all number
    11
    3
    Pyrexia
         subjects affected / exposed
    7 / 110 (6.36%)
    3 / 53 (5.66%)
         occurrences all number
    9
    4
    Injection site erythema
         subjects affected / exposed
    6 / 110 (5.45%)
    2 / 53 (3.77%)
         occurrences all number
    7
    2
    Complication associated with device
         subjects affected / exposed
    3 / 110 (2.73%)
    4 / 53 (7.55%)
         occurrences all number
    3
    5
    Oedema peripheral
         subjects affected / exposed
    4 / 110 (3.64%)
    3 / 53 (5.66%)
         occurrences all number
    9
    5
    Thirst
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 53 (5.66%)
         occurrences all number
    1
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 110 (13.64%)
    6 / 53 (11.32%)
         occurrences all number
    16
    8
    Abdominal pain
         subjects affected / exposed
    11 / 110 (10.00%)
    4 / 53 (7.55%)
         occurrences all number
    18
    4
    Diarrhoea
         subjects affected / exposed
    11 / 110 (10.00%)
    5 / 53 (9.43%)
         occurrences all number
    17
    7
    Abdominal distension
         subjects affected / exposed
    9 / 110 (8.18%)
    4 / 53 (7.55%)
         occurrences all number
    12
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 110 (1.82%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 110 (6.36%)
    1 / 53 (1.89%)
         occurrences all number
    7
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 110 (7.27%)
    5 / 53 (9.43%)
         occurrences all number
    11
    8
    Muscle spasms
         subjects affected / exposed
    7 / 110 (6.36%)
    0 / 53 (0.00%)
         occurrences all number
    9
    0
    Back pain
         subjects affected / exposed
    5 / 110 (4.55%)
    5 / 53 (9.43%)
         occurrences all number
    6
    5
    Pain in extremity
         subjects affected / exposed
    3 / 110 (2.73%)
    4 / 53 (7.55%)
         occurrences all number
    3
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 110 (9.09%)
    2 / 53 (3.77%)
         occurrences all number
    15
    2
    COVID-19
         subjects affected / exposed
    6 / 110 (5.45%)
    9 / 53 (16.98%)
         occurrences all number
    8
    9
    Urinary tract infection
         subjects affected / exposed
    6 / 110 (5.45%)
    2 / 53 (3.77%)
         occurrences all number
    6
    2
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 110 (5.45%)
    1 / 53 (1.89%)
         occurrences all number
    6
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 110 (5.45%)
    3 / 53 (5.66%)
         occurrences all number
    8
    3
    Dehydration
         subjects affected / exposed
    5 / 110 (4.55%)
    3 / 53 (5.66%)
         occurrences all number
    7
    3
    Hypomagnesaemia
         subjects affected / exposed
    6 / 110 (5.45%)
    0 / 53 (0.00%)
         occurrences all number
    8
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 110 (0.91%)
    4 / 53 (7.55%)
         occurrences all number
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2021
    Protocol Version 4 The amendment updated patient-reported outcome (PRO) assessments (PGIC, PGIS, PGI-TS, PGI-PSI) to ensure consistency across study sites. Inclusion criteria were clarified, particularly regarding surgical restrictions and the definition of chronic intestinal constipation (CIC). Exclusion criteria were revised to allow cholecystectomy within six months prior to screening. Additionally, stable dose definitions for parenteral support (PS) and other medications were refined. Reason: Improve clarity and consistency of study eligibility criteria and outcome assessments.
    13 Dec 2021
    Protocol Version 5: This amendment further modified PRO assessments and adjusted eligibility criteria by refining screening requirements for conditions such as cholecystitis, catheter infections, and prior use of GLP-2/GLP-1 analogues. A new exclusion criterion was added for subjects with familial adenomatous polyposis to enhance patient safety. Reason: Align eligibility criteria with evolving regulatory expectations and ensure scientific rigor.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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