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    Clinical Trial Results:
    FTO-genotype dependent weight reduction under treatment with bromocriptin in obese patients

    Summary
    EudraCT number
    		 2011-005628-16
    Trial protocol
    		 DE  
    Global end of trial date
    03 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1473
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS-Number: DRKS00003349
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Kerpener Str. 62, Köln, Germany, 50924
    Public contact
    Dr. Michael Faust, University of Cologne, 0049 02214784098, michael.faust@uk-koeln.de
    Scientific contact
    Dr. Michael Faust, University of Cologne, 0049 02214784098, michael.faust@uk-koeln.de
    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
    20 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    reduction of BMI
    Protection of trial subjects
    Regular visits (see sketch of study plan) during the study phase with monitoring of general condition, blood pressure measurement, recording of side effects as well as laboratory checks (blood count, kidney- and liver function tests, blood sugar) during the main visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    36
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects of the study were approached through the following procedures: - Contacting patients of the Polyclinic for Endocrinology, Diabetology and Preventive Medicine of the University Hospital Cologne -Display and flyer in the rooms of the University Hospital Cologne -Newspaper advertisement Thes

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 37
    Number of subjects completed
    		 37

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Computer assisted bock randomization.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Capsule
    Investigational medicinal product code
    Other name
    Trade name: P-tablets white 7mm Lichtenstein®
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose was 1 Capsul. The dose was increased in steps of 1 Capsule to a maximum of 4 Capsules. Ts. The assigned mediation (verum or placebo) was administered in the morning immediately after getting up. From the first dose, the mediation was administered daily for a period of 18 weeks ending with the last dose at final visit

    Arm title
    		 Verum
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bromocriptine mesilate
    Investigational medicinal product code
    Other name
    Bromocritpin ratiopharm (Tradename)
    Pharmaceutical forms
    Capsule
    Routes of administration
    Ocular use
    Dosage and administration details
    Each tablet contains 2.87mg bromocriptine mesilate, corresponding to 2.5 mg bromocriptine, for the preparation in the clinical trial half a tablet of bromocriptine was used for the preparation of a capsule used in the clinical trial. In the trial the content of half a tablet of bromocriptine 2.5mg was used, giving a dosage of 1.25mg per capsule. Starting dose was 1.25 mg per day (1 Capsule). The dose was increased in steps of 1.25 mg to a maximum of 5 mg per day (4 Capsules) if tolerated. The assigned mediation (verum or placebo) was administered in the morning immediately after getting up. From the first dose, the mediation was administered daily for a period of 18 weeks ending with the last dose at final visit.

    Number of subjects in period 1
    		Placebo Verum
    Started
    18
    19
    Completed
    13
    12
    Not completed
    5
    7
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    -
    3
         private reasons, lack of time
    3
    2
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Verum Total
    Number of subjects
    		 18 19 37
    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
        median (full range (min-max))
    		 46.3 (20 to 66) 44.2 (28 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 19
        Male
    		 8 10 18
    FTO risk allele status
    Units: Subjects
        FTO risk allele absent (wild type)
    		 7 6 13
        FTO risk allele heterozygous
    		 8 9 17
        FTO risk allele homozygous
    		 3 4 7
    Body mass index (BMI)
    kg/m2
    Units: kg/m2
        median (full range (min-max))
    		 37.1 (30.6 to 53.7) 39.1 (30 to 51.6) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Verum
    Reporting group description
    		 -

    Primary: Change in Body Mass Index

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    End point title
    		 Change in Body Mass Index
    End point description
    End point type
    Primary
    End point timeframe
    23.09.2013 to 30.12.2014
    End point values
    		 Placebo Verum
    Number of subjects analysed
    18
    19
    Units: kg/m2
        median (standard deviation)
    -0.42 ± 0.99
    -0.25 ± 1.26
    Statistical analysis title
    		 Statistic primary endpoint
    Statistical analysis description
    The primary outcome variable is the change in BMI (difference) from the beginning to the end of the treatment phase. This is compared between treatment groups using exploratory evaluation techniques and is used to determine an effect for the following confirmatory study. The evaluation of the change within the genotype subgroups, as well as the evaluation of the secondary target parameters, is exploratory. Giving the number of cases of 15 patients per treatment group, the one-sided significa
    Comparison groups
    Placebo v Verum
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    06.05.2013 to 03.06.2015
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Adverse events in whole study population
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events in whole study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 37 (8.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fracture of radius
    Additional description: Fracture of left radial head
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Swalloing a medicine blister
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse events in whole study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 37 (40.54%)
    Vascular disorders
    Dizziness postural
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    4
    Hypotension
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 37 (32.43%)
         occurrences all number
    13
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    3
    Dysphagia
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    5 / 37 (13.51%)
         occurrences all number
    6
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    1
    Psychiatric disorders
    Sleeping disorder
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Dorsalgia
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Pain of knee
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2013
    Adjustment of an exclusion criterion due to an amendment of the summary of product characteristics to the test substance by the drug manufacturers
    04 Dec 2013
    Increasing of cases due to high drop-out rate

    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.
    The number of cases in the study was small. The prespecified strata with different genotypes could not be completely filled despite an increase in the total number of subjects included.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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