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    Clinical Trial Results:
    Synergy effect of the appetite hormone GLP-1 (LiragluTide) and Exercise on maintenance of weight loss and health after a low calorie diet - the S-LiTE randomized trial

    Summary
    EudraCT number
    		 2015-005585-32
    Trial protocol
    		 DK  
    Global end of trial date
    17 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2022
    First version publication date
    18 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    111111733104
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1173-3104
    Sponsors
    Sponsor organisation name
    University of Copenhagen
    Sponsor organisation address
    Blegdamsvej 3B, Copenhagen, Denmark,
    Public contact
    Signe Torekov, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, torekov@sund.ku.dk
    Scientific contact
    Signe Torekov, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, torekov@sund.ku.dk
    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
    18 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the maintenance of weight loss and health outcomes over 1 year with GLP-1 treatment (liraglutide), exercise treatment and the combination in persons with obesity who hav obtained at least 5 % body weight loss by low calorie diet during 8 weeks.
    Protection of trial subjects
    Regular consultations to control medication uptitration and assess adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 215
    Worldwide total number of subjects
    215
    EEA total number of subjects
    215
    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)
    215
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was be done via local newspapers, online media and flyers from Department of Endocrinology, Hvidovre University Hospital, and Department of Biomedical Sciences, University of Copenhagen.

    Pre-assignment
    Screening details
    		 Inclusion criteria: BMI: 32–43 kg/m2; Age: 18–65 years; Safe contraceptive method or menopause for women.

    Period 1
    Period 1 title
    Low-calorie diet
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Low-calorie diet
    Arm description
    		 800 cal/day for 8 weeks
    Arm type
    		 Pre-randomization run-in

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Low-calorie diet
    Started
    215
    Completed
    195
    Not completed
    20
         Consent withdrawn by subject
    1
         inclusion/exclusion criteria
    5
         Lost to follow-up
    4
         non-compliance
    4
         Personal life condition
    3
         not specified
    3
    Period 2
    Period 2 title
    Randomization period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Volume-matched to liraglutide.

    Arm title
    		 Exercise
    Arm description
    		 Exercise program + placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Volume-matched to liraglutide.

    Arm title
    		 Liraglutide
    Arm description
    		 Liraglutide 3.0 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Saxenda
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting dose was 0.6 mg/day with weekly increments of 0.6 mg until 3.0 mg/day (or highest tolerable dose) was reached.

    Arm title
    		 Exercise + Liraglutide
    Arm description
    		 Exercise program plus liraglutide 3.0 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Saxenda
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting dose was 0.6 mg/day with weekly increments of 0.6 mg until 3.0 mg/day (or highest tolerable dose) was reached.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: This was an initial low-calorie diet phase that preceded the randomization period. Therefore, baseline was after completion of the first study period.
    Number of subjects in period 2 [2]
    		Placebo Exercise Liraglutide Exercise + Liraglutide
    Started
    49
    48
    49
    49
    Completed
    40
    40
    41
    45
    Not completed
    9
    8
    8
    4
         Consent withdrawn by subject
    2
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    1
         Lost to follow-up
    1
    2
    2
    -
         Personal life condition
    4
    3
    4
    1
         non-compliance
    -
    1
    -
    -
         Lack of efficacy
    1
    -
    -
    -
         not specified
    1
    2
    1
    2
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Only participants who completed the initial low-calorie diet were randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomization period
    Reporting group description
    		 -

    Reporting group values
    		 Randomization period Total
    Number of subjects
    		 195 195
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    		 124 124
        Male
    		 71 71
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 32.6 ± 2.9 -

    End points

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    End points reporting groups
    Reporting group title
    Low-calorie diet
    Reporting group description
    		 800 cal/day for 8 weeks
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo treatment

    Reporting group title
    Exercise
    Reporting group description
    		 Exercise program + placebo

    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide 3.0 mg

    Reporting group title
    Exercise + Liraglutide
    Reporting group description
    		 Exercise program plus liraglutide 3.0 mg

    Primary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    End point type
    Primary
    End point timeframe
    From week 0 (randomization) to week 52
    End point values
    		 Low-calorie diet Placebo Exercise Liraglutide Exercise + Liraglutide
    Number of subjects analysed
    195
    49
    48
    49
    49
    Units: kg
        least squares mean (confidence interval 95%)
    -13.1 (-13.7 to -12.4)
    6.1 (3.5 to 8.7)
    2.0 (-0.7 to 4.6)
    -0.7 (-3.2 to 1.8)
    -3.4 (-5.9 to -0.9)
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Placebo v Exercise + Liraglutide
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.1
         upper limit
    		 -5.9
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -3.1
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Liraglutide v Exercise + Liraglutide
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 0.8
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Placebo v Exercise
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 -0.4
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Exercise v Exercise + Liraglutide
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 -1.7

    Secondary: Change in body fat percentage

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    End point title
    		 Change in body fat percentage
    End point description
    End point type
    Secondary
    End point timeframe
    From week 0 (randomization) to week 52
    End point values
    		 Low-calorie diet Placebo Exercise Liraglutide Exercise + Liraglutide
    Number of subjects analysed
    195
    49
    48
    49
    49
    Units: percentage points
        least squares mean (confidence interval 95%)
    -2.3 (-2.6 to -2.1)
    0.4 (-0.6 to 1.5)
    -1.8 (-2.9 to -0.7)
    -1.6 (-2.6 to -0.6)
    -3.5 (-4.5 to -2.5)
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Exercise + Liraglutide v Liraglutide
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -0.5
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Exercise v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 -0.7
    Statistical analysis title
    		 Linear mixed model analysis
    Comparison groups
    Exercise v Exercise + Liraglutide
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 -0.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    week 0 (randomization) to week 52
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Exercise
    Reporting group description
    		 -

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Exercise + Liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Exercise Liraglutide Exercise + Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 48 (8.33%)
    6 / 49 (12.24%)
    4 / 49 (8.16%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    2 / 49 (4.08%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 48 (4.17%)
    1 / 49 (2.04%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Exercise Liraglutide Exercise + Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 49 (85.71%)
    39 / 48 (81.25%)
    49 / 49 (100.00%)
    45 / 49 (91.84%)
    Injury, poisoning and procedural complications
    Accident/injury
         subjects affected / exposed
    3 / 49 (6.12%)
    6 / 48 (12.50%)
    3 / 49 (6.12%)
    13 / 49 (26.53%)
         occurrences all number
    3
    6
    3
    13
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    6 / 49 (12.24%)
    2 / 49 (4.08%)
         occurrences all number
    1
    0
    6
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 49 (18.37%)
    10 / 48 (20.83%)
    10 / 49 (20.41%)
    11 / 49 (22.45%)
         occurrences all number
    9
    10
    10
    11
    Dizziness
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 48 (8.33%)
    15 / 49 (30.61%)
    11 / 49 (22.45%)
         occurrences all number
    3
    4
    15
    11
    Other
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 48 (8.33%)
    0 / 49 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    2
    4
    0
    3
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    8 / 49 (16.33%)
    10 / 48 (20.83%)
    11 / 49 (22.45%)
    7 / 49 (14.29%)
         occurrences all number
    8
    10
    11
    7
    Fatigue
         subjects affected / exposed
    4 / 49 (8.16%)
    6 / 48 (12.50%)
    15 / 49 (30.61%)
    8 / 49 (16.33%)
         occurrences all number
    4
    6
    15
    8
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 49 (12.24%)
    7 / 48 (14.58%)
    9 / 49 (18.37%)
    12 / 49 (24.49%)
         occurrences all number
    6
    7
    9
    12
    Diarrhoea
         subjects affected / exposed
    4 / 49 (8.16%)
    7 / 48 (14.58%)
    13 / 49 (26.53%)
    14 / 49 (28.57%)
         occurrences all number
    4
    7
    13
    14
    Nausea
         subjects affected / exposed
    8 / 49 (16.33%)
    15 / 48 (31.25%)
    32 / 49 (65.31%)
    26 / 49 (53.06%)
         occurrences all number
    8
    15
    32
    26
    Vomiting
         subjects affected / exposed
    2 / 49 (4.08%)
    6 / 48 (12.50%)
    11 / 49 (22.45%)
    15 / 49 (30.61%)
         occurrences all number
    2
    6
    11
    15
    Dyspepsia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    9 / 49 (18.37%)
    9 / 49 (18.37%)
         occurrences all number
    0
    1
    9
    9
    Abdominal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    13 / 48 (27.08%)
    18 / 49 (36.73%)
    12 / 49 (24.49%)
         occurrences all number
    3
    13
    18
    12
    Flatulence or abdominal distension
         subjects affected / exposed
    5 / 49 (10.20%)
    4 / 48 (8.33%)
    5 / 49 (10.20%)
    8 / 49 (16.33%)
         occurrences all number
    5
    4
    5
    8
    Dry mouth
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    3 / 49 (6.12%)
    4 / 49 (8.16%)
         occurrences all number
    2
    0
    3
    4
    Pyrexia
         subjects affected / exposed
    4 / 49 (8.16%)
    9 / 48 (18.75%)
    7 / 49 (14.29%)
    14 / 49 (28.57%)
         occurrences all number
    4
    9
    7
    14
    Other
         subjects affected / exposed
    4 / 49 (8.16%)
    5 / 48 (10.42%)
    6 / 49 (12.24%)
    5 / 49 (10.20%)
         occurrences all number
    4
    5
    6
    5
    Respiratory, thoracic and mediastinal disorders
    Other
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 48 (8.33%)
    3 / 49 (6.12%)
    3 / 49 (6.12%)
         occurrences all number
    3
    4
    3
    3
    Skin and subcutaneous tissue disorders
    Hair loss
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    3 / 49 (6.12%)
    6 / 49 (12.24%)
         occurrences all number
    2
    0
    3
    6
    Other
         subjects affected / exposed
    4 / 49 (8.16%)
    4 / 48 (8.33%)
    5 / 49 (10.20%)
    7 / 49 (14.29%)
         occurrences all number
    4
    4
    5
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 48 (4.17%)
    4 / 49 (8.16%)
    4 / 49 (8.16%)
         occurrences all number
    4
    2
    4
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 48 (8.33%)
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences all number
    2
    4
    3
    1
    Other
         subjects affected / exposed
    9 / 49 (18.37%)
    12 / 48 (25.00%)
    5 / 49 (10.20%)
    10 / 49 (20.41%)
         occurrences all number
    9
    12
    5
    10
    Infections and infestations
    Influenza or influenza-like symptoms
         subjects affected / exposed
    8 / 49 (16.33%)
    8 / 48 (16.67%)
    11 / 49 (22.45%)
    13 / 49 (26.53%)
         occurrences all number
    8
    8
    11
    13
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 49 (26.53%)
    17 / 48 (35.42%)
    12 / 49 (24.49%)
    13 / 49 (26.53%)
         occurrences all number
    13
    17
    12
    13
    Urinary tract infection
         subjects affected / exposed
    3 / 49 (6.12%)
    5 / 48 (10.42%)
    6 / 49 (12.24%)
    3 / 49 (6.12%)
         occurrences all number
    3
    5
    6
    3
    Other
         subjects affected / exposed
    2 / 49 (4.08%)
    8 / 48 (16.67%)
    7 / 49 (14.29%)
    5 / 49 (10.20%)
         occurrences all number
    2
    8
    7
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 48 (8.33%)
    18 / 49 (36.73%)
    16 / 49 (32.65%)
         occurrences all number
    2
    4
    18
    16
    Hunger
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    2 / 49 (4.08%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    2
    1
    Taste disorder
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2016
    • Increasing the upper body mass index limit (inclusion criteria) from 40 kg/m2 to 43 kg/m2 to increase the possibility that the aimed number of study participants will be reached within the planned trial period. • Adding an exclusion criteria (upper limit of max 2 hours of regular exercise training at vigorous intensity) to ensure that the physical activity levels of the study participants are comparable. • Specifying methodological details on the exercise intervention (e.g. target intensity) • Specifying methodological details and add ethical considerations of the genomic examinations from blood and semen samples (cf. new Danish regulations on this area from 2016), including which genomic tests are performed and why.
    08 Oct 2018
    • Adding a post-treatment follow-up visit to investigate anthropometric and metabolic outcomes one year after completion of the trial. • Prolonging the trial period from August 2016-August 2021 to August 2016-August 2023 due to addition of the post-treatment follow-up visit. • Increasing the number of included study participants from 180 to 200 to increase the possibility that the aimed number of study participants of minimum 30 persons in each treatment arm complete the trial within the planned trial period. • Removing statement of two planned exploratory examinations (MR scan for hepatic fat content and activation of brown fat tissue) as these were not performed.
    20 Nov 2019
    • Increasing the total number of included study participants from 200 to 222 because some of the individuals who had been given a study ID number at pre-screening never attended the first day of the run-in phase and thus did never initiate the trial (e.g. due to waiting time from prescreening to the first day of run-in). • Specifying details of the definition of the intention-to-treat analysis set to include all randomized participants • Specifying details on the statistical method and refer to the statistical analysis plan

    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/33951361
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