Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery.

    Summary
    EudraCT number
    		 2017-002407-10
    Trial protocol
    		 GB  
    Global end of trial date
    24 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    17/0238
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03341429
    WHO universal trial number (UTN)
    		 U1111-1185-8283
    Other trial identifiers
    		 UCL Data Protection Registration Number: Z6364106/2017/12/103
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    1st floor Maple House, 149 Tottenham Court Road, London, United Kingdom, W1T 7NF
    Public contact
    Alisia Carnemolla, UCL, a.carnemolla@ucl.ac.uk
    Scientific contact
    Alisia Carnemolla, UCL/UCLH Joint Research Office, randd@nhs.net
    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
    24 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to compare the efficacy of 24 weeks of subcutaneous liraglutide 3.0 mg versus placebo administration, as an adjunct to diet and exercise, on %WL in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG at the end of the 24-week treatment period.
    Protection of trial subjects
    Patients were exposed to ionising radiation during the DXA scans: this is not a painful procedure. However, to minimise risks inherent to the procedure, only a trained DXA operator will undertake the procedure. Blood sampling involved a venepuncture in the forearm which is a commonly performed routine procedure and does not involve any pain or discomfort other than a little scratch at needle insertion. A trained healthcare professional performed the venepuncture. Side effects of the study drug included nausea, vomiting or diarrhoea related: participant were provided with details of persons to contact should they have any problem while on the treatment. In addition, participants were monitored closely throughout the study period. In the case of a severe adverse event where it is necessary for the authorised investigator and treating health care professional to know which treatment the participant is receiving before providing appropriate treatment arrangements for the trial code to be broken to reveal group allocation were in place. Participants were expected to experience time and financial constraints to attend a total of 7 study visits. Any reasonable travel expenses incurred by participants in attending the study visits were reimbursed.
    Background therapy
    		 Counselling on lifestyle modification (500-kcal deficient diet and 150 minute of physical activity/week).
    Evidence for comparator
    		 A placebo, which does not contain any active ingredients, but similar in appearance was used as comparator.
    Actual start date of recruitment
    31 Jul 2018
    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
    United Kingdom: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    0
    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
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment took place between 1st April 2018 and 28th November 2019. Participants were recruited from UCLH Trust and Homerton University Hospital Foundation Trust.

    Pre-assignment
    Screening details
    		 Interested subjects were asked to sign a first consent form in order to undergo screening for the trial, as the assessment included a meal test that is considered research procedure. Written informed consent was sought within one week with a minimum of 24 hours after being approached and given the Participants Information Sheet.

    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
    Blinding implementation details
    The pharmacist and the Trial Co-ordinator were the solely holders of the code list, other than Sealed Envelope, the company providing the randomisation system.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 3.0 mg liraglutide, once daily via subcutaneous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    ACT: A10BJ02
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage: 3.0 mg liraglutide/placebo, daily subcutaneous injection for 20 weeks following a dose escalation period of 4 weeks. Dose escalation (4 weeks)= Week 1: 0.6 mg, Week 2: 1.2 mg, Week 3: 1.8 mg, Week 4 2.4 mg. Week 5 – 24: Maintenance dose 3.0 mg

    Arm title
    		 Placebo
    Arm description
    		 Control, no active ingredient, but same appearance
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Once daily subcutaneous injection

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    35
    35
    Completed
    31
    26
    Not completed
    4
    9
         no BIA weight at V7
    4
    9

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 70 70
    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)
    		 70 70
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.55 ± 10.7 -
    Gender categorical
    Units: Subjects
        Female
    		 52 52
        Male
    		 18 18
    Type 2 Diabetes
    Units: Subjects
        T2D Status - Diabetic
    		 9 9
        T2D Status - Non Diabetic
    		 61 61
    Surgical procedure
    Units: Subjects
        RYGB
    		 5 5
        SG
    		 65 65
    Ethnicity
    White British, White Irish, and White Other combined to form White group. African, Caribbean and Black other combined to form Black group Indian, Pakistani, Bangladeshi and other Asian background combined to form Asian group
    Units: Subjects
        White
    		 44 44
        Black
    		 14 14
        Asian
    		 5 5
        Other mixed background
    		 3 3
        White & Asian
    		 1 1
        White & Black Caribbean
    		 3 3
    Family history of obesity
    Units: Subjects
        Yes
    		 52 52
        No
    		 18 18
    Education level
    Units: Subjects
        None
    		 4 4
        GCSE/O level or equivalent
    		 18 18
        A level or equivalent
    		 19 19
        Degree
    		 21 21
        Postgraduate
    		 8 8
    IPAQ
    The IPAQ questionnaire was used to categorise the levels of activities of the participants
    Units: Subjects
        Low
    		 26 26
        Moderate
    		 23 23
        High
    		 20 20
        Not recorded
    		 1 1
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 119.78 ± 24.3 -
    Fat mass
    Fat mass measured using DXA, it was measured in grams, for the analysis, the unit was converted to kilograms. 2 patients in the placebo were missing baseline fat mass measurement.
    Units: kg
        arithmetic mean (standard deviation)
    		 51.9 ± 13.5 -
    Lean mass
    Lean mass measured using DXA, it was measured in grams, for the analysis, the unit was converted to kilograms. 2 patients in the placebo were missing baseline lean mass measurement.
    Units: kg
        arithmetic mean (standard deviation)
    		 65.5 ± 12.2 -
    Bone density
    Bone density measured using DXA. 2 patients in the placebo were missing baseline bone density measurement.
    Units: g/cm2
        arithmetic mean (standard deviation)
    		 1.2 ± 0.1 -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 5.2 ± 1.4 -
    HbA1c
    Units: percentage
        arithmetic mean (standard deviation)
    		 5.9 ± 0.8 -
    Heart rate
    The heart rate is the pre six minute walk test heart rate
    Units: Beats per minute
        arithmetic mean (standard deviation)
    		 75.7 ± 12.6 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 131.3 ± 14.7 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76.0 ± 10.7 -
    BDI
    Units: Subjects
        arithmetic mean (standard deviation)
    		 15.0 ± 11.9 -
    IWQOL
    IWQOL total score
    Units: Subjects
        arithmetic mean (standard deviation)
    		 56.1 ± 23.3 -
    6 Minute Walk Test
    Units: meter
        arithmetic mean (standard deviation)
    		 455.1 ± 92.5 -
    5 Sit Stand Test
    Units: second
        arithmetic mean (standard deviation)
    		 12.7 ± 4.4 -
    Hand Grip Test
    Units: kg
        arithmetic mean (standard deviation)
    		 33.6 ± 11.9 -
    Insulin - 0 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm).
    Units: iu/L
        arithmetic mean (standard deviation)
    		 10.7 ± 7.4 -
    Insulin - 15 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    		 94.5 ± 62.3 -
    Insulin - 30 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    		 100.7 ± 65.0 -
    Insulin - 60 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    		 111.6 ± 78.9 -
    Insulin - 120 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    		 30.2 ± 20.5 -
    Insulin - 180 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    		 11.9 ± 10.5 -
    IWQOL-lite physical function
    Units: Subjects
        arithmetic mean (standard deviation)
    		 55.6 ± 25.1 -
    IWQOL-lite self-esteem
    Units: Subjects
        arithmetic mean (standard deviation)
    		 42.5 ± 29.0 -
    IWQOL-lite sex life
    2 sex-life scores missing (1 each arm)
    Units: Subjects
        arithmetic mean (standard deviation)
    		 62.7 ± 32.3 -
    IWQOL-lite public distress
    Units: Subjects
        arithmetic mean (standard deviation)
    		 59.2 ± 29.3 -
    IWQOL-lite work
    1 missing work score in liraglutide arm
    Units: Subjects
        arithmetic mean (standard deviation)
    		 72.2 ± 28.9 -
    Subject analysis sets

    Subject analysis set title
    Liraglutide
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants that received the study drug, liraglutide 3.0 mg/ml

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants that received placebo.

    Subject analysis sets values
    		 Liraglutide Placebo
    Number of subjects
    35
    35
    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)
    35
    35
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.7 ± 10.8
    48.4 ± 10.6
    Gender categorical
    Units: Subjects
        Female
    26
    26
        Male
    9
    9
    Type 2 Diabetes
    Units: Subjects
        T2D Status - Diabetic
    5
    4
        T2D Status - Non Diabetic
    30
    31
    Surgical procedure
    Units: Subjects
        RYGB
    2
    3
        SG
    33
    32
    Ethnicity
    White British, White Irish, and White Other combined to form White group. African, Caribbean and Black other combined to form Black group Indian, Pakistani, Bangladeshi and other Asian background combined to form Asian group
    Units: Subjects
        White
    22
    22
        Black
    5
    9
        Asian
    4
    1
        Other mixed background
    1
    2
        White & Asian
    1
    0
        White & Black Caribbean
    2
    1
    Family history of obesity
    Units: Subjects
        Yes
    23
    29
        No
    12
    6
    Education level
    Units: Subjects
        None
    2
    2
        GCSE/O level or equivalent
    11
    7
        A level or equivalent
    5
    14
        Degree
    12
    9
        Postgraduate
    5
    3
    IPAQ
    The IPAQ questionnaire was used to categorise the levels of activities of the participants
    Units: Subjects
        Low
    11
    15
        Moderate
    15
    8
        High
    8
    12
        Not recorded
    1
    0
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    116.1 ± 23.6
    123.5 ± 24.8
    Fat mass
    Fat mass measured using DXA, it was measured in grams, for the analysis, the unit was converted to kilograms. 2 patients in the placebo were missing baseline fat mass measurement.
    Units: kg
        arithmetic mean (standard deviation)
    49.4 ± 11.3
    54.2 ± 15.1
    Lean mass
    Lean mass measured using DXA, it was measured in grams, for the analysis, the unit was converted to kilograms. 2 patients in the placebo were missing baseline lean mass measurement.
    Units: kg
        arithmetic mean (standard deviation)
    63.7 ± 11.0
    67.1 ± 13.1
    Bone density
    Bone density measured using DXA. 2 patients in the placebo were missing baseline bone density measurement.
    Units: g/cm2
        arithmetic mean (standard deviation)
    1.2 ± 0.1
    1.2 ± 0.1
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    5.0 ± 1.3
    5.3 ± 1.5
    HbA1c
    Units: percentage
        arithmetic mean (standard deviation)
    5.8 ± 0.7
    6.0 ± 0.9
    Heart rate
    The heart rate is the pre six minute walk test heart rate
    Units: Beats per minute
        arithmetic mean (standard deviation)
    74.0 ± 13.6
    77.3 ± 11.5
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    131.3 ± 15.0
    131.3 ± 14.5
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    75.9 ± 10.4
    76.2 ± 11.2
    BDI
    Units: Subjects
        arithmetic mean (standard deviation)
    16.3 ± 10.0
    13.8 ± 13.6
    IWQOL
    IWQOL total score
    Units: Subjects
        arithmetic mean (standard deviation)
    56.3 ± 23.8
    55.8 ± 23.1
    6 Minute Walk Test
    Units: meter
        arithmetic mean (standard deviation)
    464.5 ± 89.7
    445.6 ± 95.7
    5 Sit Stand Test
    Units: second
        arithmetic mean (standard deviation)
    13.3 ± 5.4
    12.2 ± 3.3
    Hand Grip Test
    Units: kg
        arithmetic mean (standard deviation)
    31.6 ± 9.9
    35.6 ± 13.5
    Insulin - 0 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm).
    Units: iu/L
        arithmetic mean (standard deviation)
    10.0 ± 7.0
    11.4 ± 8.1
    Insulin - 15 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    98.8 ± 64.7
    89.2 ± 60.7
    Insulin - 30 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    119.3 ± 78.0
    100.2 ± 44.4
    Insulin - 60 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    110.4 ± 78.2
    113.1 ± 82.1
    Insulin - 120 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    31.0 ± 21.2
    29.1 ± 20.2
    Insulin - 180 minute
    30 insulin measurements missing (17 in placebo arm and 13 in liraglutide arm)
    Units: iu/L
        arithmetic mean (standard deviation)
    12.9 ± 12.5
    10.8 ± 7.6
    IWQOL-lite physical function
    Units: Subjects
        arithmetic mean (standard deviation)
    55.0 ± 25.2
    56.1 ± 25.4
    IWQOL-lite self-esteem
    Units: Subjects
        arithmetic mean (standard deviation)
    43.3 ± 29.4
    41.7 ± 29.0
    IWQOL-lite sex life
    2 sex-life scores missing (1 each arm)
    Units: Subjects
        arithmetic mean (standard deviation)
    61.8 ± 30.9
    63.6 ± 34.0
    IWQOL-lite public distress
    Units: Subjects
        arithmetic mean (standard deviation)
    63.3 ± 27.8
    55.1 ± 30.6
    IWQOL-lite work
    1 missing work score in liraglutide arm
    Units: Subjects
        arithmetic mean (standard deviation)
    71.1 ± 31.3
    73.2 ± 26.7

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 3.0 mg liraglutide, once daily via subcutaneous injection

    Reporting group title
    Placebo
    Reporting group description
    		 Control, no active ingredient, but same appearance

    Subject analysis set title
    Liraglutide
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants that received the study drug, liraglutide 3.0 mg/ml

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants that received placebo.

    Primary: Primary outcome - % weight loss

    		 Close Top of page
    End point title
    		 Primary outcome - % weight loss
    End point description
    The primary outcome of this trial is %WL from the baseline visit to the end of treatment visit at 24 weeks. Percentage weight loss will be calculated using the following formula: %WL = [(weight at the baseline visit–weight at the end of the 24-week treatment period)/ weight at the baseline visit] x 100, measured at the end of trial.
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    26
    Units: percent
        arithmetic mean (standard deviation)
    -8.8 ± 4.9
    -0.5 ± 3.3
    Statistical analysis title
    		 Primary Outcome Analysis
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -5.7
    Notes
    [1] - Specifically, the following linear regression model will be fitted: 〖%WL〗_i=β_0+β_1 TRT_i+〖β_2 Baseline_weight〗_i 〖+ 〖β_3 Type〗_i+β_4 〖T2D〗_i+ϵ〗_i where: %〖WL〗_i is the weight loss at 24 weeks for the ith patient TRT_i is an indicator for the allocated treatment for the ith patient (0 = placebo, 1 = liraglutide) 〖Baseline_weight〗_i is the weight at baseline for the ith patient 〖Type〗_i is an indicator for the type of surgical treatment the ith patient receives (0 = SG , 1 = RYGB) and i
    Statistical analysis title
    		 Sensitivity analysis for influential points
    Statistical analysis description
    A sensitivity analysis for influential points was carried out, observations with leverage greater than or equal to 0.1, 13 observations (5 in placebo and 8 in liraglutide arm), were removed and the primary outcome model was re-fitted.
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.4
         upper limit
    		 -6.1
    Statistical analysis title
    		 Sensitivity analysis for normality
    Statistical analysis description
    A quantile regression model for median was fitted as a sensitivity analysis for the violation of the normality assumption of residuals in the primary analysis.
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Quantile regression for median
    Parameter type
    		 Median difference (final values)
    Point estimate
    -8.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -5.3
    Statistical analysis title
    		 Sensitivity analysis for homoscedasticity
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Linear regression with robust SE
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 -5.7

    Primary: % WL self reported weight

    		 Close Top of page
    End point title
    		 % WL self reported weight
    End point description
    BIA measurement could not be completed for 1 patient in placebo arm because they had unstable feet, but their weight was measured in at the clinic. 7 patients in placebo arm that could not attend the 24-week visit due to covid-19 restrictions provided self-reported weights. 1 patient in liraglitide arm could not attend 24-week visit due to tooth infection also provided self-reported weight. As a secondary analysis, the self-reported weights were used in addition to the original data available
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: percent
        arithmetic mean (standard deviation)
    -8.6 ± 5.0
    -0.1 ± 3.3
    Statistical analysis title
    		 % WL - self reported weight
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -6.2

    Primary: % WL over time (week 2)

    		 Close Top of page
    End point title
    		 % WL over time (week 2)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    30
    Units: percent
        arithmetic mean (standard deviation)
    -1.8 ± 1.0
    -0.3 ± 1.0
    Statistical analysis title
    		 % WL over time (week 2)
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 -0.3

    Primary: % WL over time (week 4)

    		 Close Top of page
    End point title
    		 % WL over time (week 4)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    33
    Units: percent
        arithmetic mean (standard deviation)
    -3.4 ± 1.4
    -0.4 ± 1.3
    Statistical analysis title
    		 % WL over time (week 4)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -1.7

    Primary: % WL over time (week 8)

    		 Close Top of page
    End point title
    		 % WL over time (week 8)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: percent
        arithmetic mean (standard deviation)
    -5.0 ± 2.1
    -0.4 ± 1.9
    Statistical analysis title
    		 % WL over time (week 8)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 -3.2

    Primary: % WL over time (17 weeks)

    		 Close Top of page
    End point title
    		 % WL over time (17 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    29
    30
    Units: percent
        arithmetic mean (standard deviation)
    7.8 ± 3.9
    -0.7 ± 2.7
    Statistical analysis title
    		 % WL over time (week 17)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 -5.6

    Primary: % WL over time (24 weeks)

    		 Close Top of page
    End point title
    		 % WL over time (24 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Primary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: percent
        arithmetic mean (standard deviation)
    -8.6 ± 5.0
    -0.1 ± 3.3
    Statistical analysis title
    		 % WL over time (week 24)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 -7.2

    Secondary: Actual weight loss

    		 Close Top of page
    End point title
    		 Actual weight loss
    End point description
    End point type
    Secondary
    End point timeframe
    Weight was measured at baseline, 2 weeks, 4 weeks, 8 weeks, 17 weeks and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: kg
        arithmetic mean (standard deviation)
    -9.5 ± 5.1
    -0.4 ± 3.9
    Statistical analysis title
    		 Actual weight loss at 24 weeks
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.5
         upper limit
    		 -6.9

    Secondary: Change in fat mass between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in fat mass between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24-week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    23
    24
    Units: kg
        arithmetic mean (standard deviation)
    -4.1 ± 4.2
    0.7 ± 3.9
    Statistical analysis title
    		 Change in fatmass from baseline to 24-week
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 -2.5

    Secondary: Change in lean mass between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in lean mass between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24-week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    23
    24
    Units: kg
        arithmetic mean (standard deviation)
    -4.2 ± 3.0
    -1.1 ± 3.3
    Statistical analysis title
    		 Change in lean mass between baseline and 24 weeks
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 -1.6

    Secondary: Change in bone density between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in bone density between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Bone density was measured at baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    23
    24
    Units: g/cm2
        arithmetic mean (standard deviation)
    -0.01 ± 0.02
    0.0005 ± 0.04
    Statistical analysis title
    		 Change in bone density
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.02

    Secondary: Change in glucose between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in glucose between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    27
    27
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.43 ± 0.81
    -0.02 ± 0.88
    Statistical analysis title
    		 Change in glucose
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 -0.17

    Secondary: Change in HbA1c between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in HbA1c between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    26
    27
    Units: Percentage
        arithmetic mean (standard deviation)
    -0.27 ± 0.37
    -0.03 ± 0.22
    Statistical analysis title
    		 Change in HbAic
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 -0.16

    Secondary: Change in heart rate between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in heart rate between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    30
    31
    Units: beats/ minute
        arithmetic mean (standard deviation)
    4.6 ± 12.4
    2.4 ± 11.6
    Statistical analysis title
    		 Change in heartrate
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 6.2

    Secondary: Change in systolic blood pressure between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in systolic blood pressure between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 2 week, 4 week, 8 week, 17 week and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    32
    Units: mmHg
        arithmetic mean (standard deviation)
    -6.3 ± 16.4
    2.3 ± 18.9
    Statistical analysis title
    		 Change in systolic blood pressure
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 -1.9
    Statistical analysis title
    		 Change in systolic blood pressure over time
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.3
         upper limit
    		 -6.1

    Secondary: Change in diastolic blood pressure between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in diastolic blood pressure between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 2 week, 4 week, 8 week, 17 week and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    32
    Units: mmG
        arithmetic mean (standard deviation)
    -0.4 ± 13.2
    -0.3 ± 13.2
    Statistical analysis title
    		 Change in diastolic blood pressure
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 5.1
    Statistical analysis title
    		 Change in diastolic blood pressure over time
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 0.5

    Secondary: Change in insulin between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in insulin between baseline and 24 weeks
    End point description
    Repeated measures of Insulin at 0, 15, 30, 60, 120 and 180 minutes after meal.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    22
    18
    Units: mmol
        arithmetic mean (standard deviation)
    -0.7 ± 5.3
    -2.0 ± 4.5
    Statistical analysis title
    		 Change in insulin
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 19.2

    Secondary: Change in BDI scores between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in BDI scores between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    33
    Units: Subjects
        arithmetic mean (standard deviation)
    -5.7 ± 8.6
    -1.9 ± 9.4
    Statistical analysis title
    		 Change in BDI score
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 0.5

    Secondary: Change in IWQOL scores between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in IWQOL scores between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    33
    Units: Subjects
        arithmetic mean (standard deviation)
    5.0 ± 15.1
    -0.9 ± 10.7
    Statistical analysis title
    		 Change in IWQOL-Lite total score
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 13.7

    Secondary: Change in 6 Minute Walk Test between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in 6 Minute Walk Test between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    26
    24
    Units: meter
        arithmetic mean (standard deviation)
    21.3 ± 48.6
    15.5 ± 51.3
    Statistical analysis title
    		 Change in 6 minute walk test
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.1
         upper limit
    		 39.4

    Secondary: Change in 5 Sit Stand Test between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in 5 Sit Stand Test between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    25
    27
    Units: second
        arithmetic mean (standard deviation)
    -1.8 ± 3.7
    0.4 ± 3.3
    Statistical analysis title
    		 Change in 5 Sit Stand Test
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 -0.03

    Secondary: Change in Hand Grip Test between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in Hand Grip Test between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    30
    28
    Units: kg
        arithmetic mean (standard deviation)
    -2.1 ± 5.0
    -3.7 ± 10.2
    Statistical analysis title
    		 Change in Hand Grip Test
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 3.7

    Secondary: Change in CRP between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in CRP between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    27
    26
    Units: mg/L
        arithmetic mean (standard deviation)
    -1.2 ± 2.6
    -0.5 ± 2.8
    Statistical analysis title
    		 Change in CRP
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 0.3

    Secondary: Change in cholesterol between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in cholesterol between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    28
    31
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.5 ± 0.6
    0.1 ± 0.5
    Statistical analysis title
    		 Change in cholesterol
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.2

    Secondary: Change in LDL between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in LDL between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    28
    30
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.26 ± 0.58
    -0.03 ± 0.32
    Statistical analysis title
    		 Change in LDL
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.2

    Secondary: Change in HDL between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in HDL between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    28
    31
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.10 ± 0.18
    0.02 ± 0.21
    Statistical analysis title
    		 Change in HDL
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 -0.01

    Secondary: Change in triglyceride between baseline and 24 weeks

    		 Close Top of page
    End point title
    		 Change in triglyceride between baseline and 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    28
    31
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.2 ± 0.7
    0.2 ± 1.5
    Statistical analysis title
    		 Change in triglyceride
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.2

    Secondary: IPAQ at 24 weeks

    		 Close Top of page
    End point title
    		 IPAQ at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 24 week
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    33
    30
    Units: Subjects
        Low
    13
    8
        Moderate
    7
    11
        High
    13
    11
    Statistical analysis title
    		 Analysis of IPAQ questinnaire
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.9

    Secondary: Weight loss over time (2 weeks)

    		 Close Top of page
    End point title
    		 Weight loss over time (2 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    30
    Units: kg
        arithmetic mean (standard deviation)
    -2.0 ± 1.1
    -0.3 ± 1.2
    Statistical analysis title
    		 Weight loss over time (2 weeks)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 -0.6

    Secondary: Weight loss over time (4 weeks)

    		 Close Top of page
    End point title
    		 Weight loss over time (4 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    31
    33
    Units: kg
        arithmetic mean (standard deviation)
    -3.9 ± 1.7
    -0.5 ± 1.6
    Statistical analysis title
    		 Weight loss over time (4 weeks)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 -2.2

    Secondary: Weight loss over time (8 weeks)

    		 Close Top of page
    End point title
    		 Weight loss over time (8 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: kg
        arithmetic mean (standard deviation)
    -5.6 ± 2.4
    -0.6 ± 2.2
    Statistical analysis title
    		 Weight loss over time (8 weeks)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 -3.7

    Secondary: Weight loss over time (17 weeks)

    		 Close Top of page
    End point title
    		 Weight loss over time (17 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    29
    30
    Units: kg
        arithmetic mean (standard deviation)
    -8.6 ± 4.1
    -1.0 ± 3.2
    Statistical analysis title
    		 Weight loss over time (17 weeks)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 -6.2

    Secondary: Weight loss over time (24 weeks)

    		 Close Top of page
    End point title
    		 Weight loss over time (24 weeks)
    End point description
    The time-treatment interaction is significant, hence the treatment effect estimate for each week is entered separately.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (i.e., 24-week treatment): measured at baseline and at 2, 4, 8, 17 and 24 weeks post randomisation.
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: kg
        arithmetic mean (standard deviation)
    -9.5 ± 5.1
    -0.4 ± 3.9
    Statistical analysis title
    		 Weight loss over time (24 weeks)
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 -7.8

    Secondary: Difference in GP visits at the surgery or health centre between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in GP visits at the surgery or health centre between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    2.4 ± 2.5
    2.5 ± 2.5
    Statistical analysis title
    		 Difference in GP visits at the surgery or centre
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.3

    Secondary: Difference in GP visits at home between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in GP visits at home between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Secondary: Difference in Telephone calls with GP between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Telephone calls with GP between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of calls
        arithmetic mean (standard deviation)
    1.5 ± 2.9
    1.3 ± 2.2
    Statistical analysis title
    		 Difference in Telephone calls with GP
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.6

    Secondary: Difference in Nurse visits at home between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Nurse visits at home between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    0 ± 0.2
    0 ± 0.2
    Statistical analysis title
    		 Difference in Nurse visits at home
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.1

    Secondary: Difference in Nurse visits at the surgery or health centre between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Nurse visits at the surgery or health centre between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    0.7 ± 0.8
    0.7 ± 1
    Statistical analysis title
    		 Difference in Nurse visits at the surgery or centr
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.5

    Secondary: Difference in Telephone calls with nurse between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Telephone calls with nurse between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of calls
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0.2
    Statistical analysis title
    		 Difference in Telephone calls with nurse
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0

    Secondary: Difference in Visits with an NHS dietitian between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Visits with an NHS dietitian between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    0.4 ± 0.7
    0.4 ± 1.1
    Statistical analysis title
    		 Difference in Visits with an NHS dietitian
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.5

    Secondary: Difference in Visits with an NHS physiotherapist between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Visits with an NHS physiotherapist between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    24
    27
    Units: Number of visits
        arithmetic mean (standard deviation)
    0 ± 0.2
    1.2 ± 3.1
    Statistical analysis title
    		 Difference in Visits with an NHS physiotherapist
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 0.1

    Secondary: Difference in Inpatient stays between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Inpatient stays between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: Number of stays
        arithmetic mean (standard deviation)
    0.1 ± 0.3
    0 ± 0
    Statistical analysis title
    		 Difference in Inpatient stays
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.2

    Secondary: Difference in Outpatient visits between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Outpatient visits between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: Number of visits
        arithmetic mean (standard deviation)
    0.6 ± 0.9
    1 ± 1.9
    Statistical analysis title
    		 Difference in Outpatient visits
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 0.3

    Secondary: Difference in Emergency Department visits between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Emergency Department visits between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    32
    34
    Units: Number of visits
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Secondary: Difference in Number of concomitant NHS medications between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Number of concomitant NHS medications between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    33
    35
    Units: Number of medications
        arithmetic mean (standard deviation)
    6.6 ± 2.8
    5.3 ± 3
    Statistical analysis title
    		 Difference in Number of concomitant NHS medication
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 2.7

    Secondary: Difference in Number of doses of liraglutide between liraglutide and placebo from baseline to 24 weeks

    		 Close Top of page
    End point title
    		 Difference in Number of doses of liraglutide between liraglutide and placebo from baseline to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    30
    35
    Units: Number of doses
        arithmetic mean (standard deviation)
    29.8 ± 0.9
    0 ± 0
    Statistical analysis title
    		 Difference in Number of doses of liraglutide
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.5
         upper limit
    		 30.1

    Secondary: Difference in EQ-5D-3L utility score between liraglutide and placebo at 24 weeks

    		 Close Top of page
    End point title
    		 Difference in EQ-5D-3L utility score between liraglutide and placebo at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 24 weeks
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    33
    32
    Units: Utility score on a scale of 0 to 1
        arithmetic mean (standard deviation)
    0.583 ± 0.392
    0.735 ± 0.289
    Statistical analysis title
    		 Difference in EQ-5D-3L utility score
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.152
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.019
         upper limit
    		 0.324

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected and are reported on from randomisation to end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Trial specific
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 70 (100.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    5
    Dry mouth
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    7
    Headache
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal bloating
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    3 / 70 (4.29%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    11 / 70 (15.71%)
         occurrences all number
    11
    Decreased appetite
         subjects affected / exposed
    14 / 70 (20.00%)
         occurrences all number
    14
    Diarrhoea
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    25 / 70 (35.71%)
         occurrences all number
    25
    Vomiting
         subjects affected / exposed
    2 / 70 (2.86%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Influenza
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 70 (10.00%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Injection related reaction
         subjects affected / exposed
    5 / 70 (7.14%)
         occurrences all number
    6
    Urticaria
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 70 (5.71%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    1 / 70 (1.43%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2018
    Changes to the protocol requested by MHRA during their initial review of the study. To seek approval for the use of a ‘Patient Booklet’, to be distributed to participants, detailing the use of the injection pens for the administration of the study treatment. To change the PI at the PIC.
    02 Jul 2019
    To request approval for the addition of a new recruiting site. To report changes to study personnel.

    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.
    COVID-19 lockdown measures affected the collection of end of treatment data - not all participants were able to provide these.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 04 11:22:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA