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    Clinical Trial Results:
    GLP-1 Receptor Agonist interVentIon for poor responders afTer bariAtric Surgery: The GRAVITAS trial

    Summary
    EudraCT number
    		 2014-003923-23
    Trial protocol
    		 GB  
    Global end of trial date
    08 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2020
    First version publication date
    02 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1.1
    Additional study identifiers
    ISRCTN number
    		 ISRCTN13643081
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1159-1756
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    ALEXANDER MIRAS, IMPERIAL COLLEGE LONDON, +44 07958377674, a.miras@imperial.ac.uk
    Scientific contact
    ALEXANDER MIRAS, IMPERIAL COLLEGE LONDON, +44 07958377674, a.miras@imperial.ac.uk
    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
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Will liraglutide improve diabetes in patients who have not responded as well to surgery for obesity and diabetes?
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2015
    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
    United Kingdom: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    70
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from five hospitals in London, UK: Imperial College Healthcare National Health Service (NHS) Trust, Guy’s and St Thomas’ NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, St George’s University Hospitals NHS Trust, and Chelsea and Westminster Hospital NHS Foundation Trust

    Pre-assignment
    Screening details
    		 Between Jan 29, 2016, and May 2, 2018, 80 participants were randomly assigned to receive liraglutide or placebo for 26 weeks, as an adjunct to a calorie deficit diet and increased physical activity.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 Participants received Liraglutide treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    VICTOZA
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The starting dose was 0·6 mg per day, starting at week 3. The dose was increased by 0·6 mg per day each week as tolerated, up to a maximum total of 1·8 mg per day.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The starting dose was 0·6 mg per day, starting at week 3. The dose was increased by 0·6 mg per day each week, up to a maximum total of 1·8 mg per day.

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    53
    27
    Completed
    48
    23
    Not completed
    5
    4
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    2
    1
         Physician decision
    3
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants received Liraglutide treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo.

    Reporting group values
    		 Liraglutide Placebo Total
    Number of subjects
    		 53 27 80
    Age categorical
    Units: Subjects
        Adult (18-69)
    		 53 27 80
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 55 (50 to 61) 57 (52 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 33 14 47
        Male
    		 20 13 33

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants received Liraglutide treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo.

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline values for participants who completed the study

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Liraglutide vs placebo treatment tp participants who completed the study

    Primary: Change in HbA1C

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    End point title
    		 Change in HbA1C
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Primary
    End point timeframe
    baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: mmol/mol
        number (confidence interval 95%)
    0.7 (0.48 to 0.91)
    -13.3 (-19.7 to -7)
    Statistical analysis title
    		 Change in HbA1c
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0001
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [1] - Multivariable linear regression

    Secondary: Changes from baseline in bodyweight

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    End point title
    		 Changes from baseline in bodyweight
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: kg
        arithmetic mean (confidence interval 95%)
    0.95 (0.89 to 1.0)
    -4.23 (-6.81 to -1.64)
    Statistical analysis title
    		 Bodyweight
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0017
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Changes in systolic blood pressure

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    End point title
    		 Changes in systolic blood pressure
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    0.65 (0.47 to 0.84)
    2.14 (-4.52 to 8.80)
    Statistical analysis title
    		 Systolic blood pressure
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Changes in Diastolic blood pressure

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    End point title
    		 Changes in Diastolic blood pressure
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    0.51 (0.33 to 0.7)
    2.88 (-1.67 to 7.44)
    Statistical analysis title
    		 Diastolic blood pressure
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Changes in total cholesterol

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    End point title
    		 Changes in total cholesterol
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    0.58 (0.42 to 0.75)
    -0.03 (-0.41 to 0.35)
    Statistical analysis title
    		 Total cholesterol
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: Changes in triglycerides

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    End point title
    		 Changes in triglycerides
    End point description
    Data are estimated mean differences and 95%CI.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    		 Baseline Treatment
    Number of subjects analysed
    71
    71
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    0.18 (0.1 to 0.25)
    -0.26 (-0.56 to 0.04)
    Statistical analysis title
    		 Triglycerides
    Comparison groups
    Baseline v Treatment
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.089
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    26 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants received Liraglutide treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo.

    Serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 27 (7.41%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Lymphoma
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin and subcutaneous tissue disorders
    Cellulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Progression in chronic kidney disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (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: 0%
    Non-serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 53 (49.06%)
    18 / 27 (66.67%)
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 53 (16.98%)
    4 / 27 (14.81%)
         occurrences all number
    9
    4
    Diarrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    4 / 53 (7.55%)
    2 / 27 (7.41%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Peripheral oedema
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Mar 2016
    Removal of the upper age limit for inclusion and expansion of the allowable diabetes drugs for inclusion.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31174993
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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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