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    Clinical Trial Results:
    The role of leptin in regulating hepatic lipid metabolism in humans

    Summary
    EudraCT number
    		 2017-003014-22
    Trial protocol
    		 AT  
    Global end of trial date
    24 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2026
    First version publication date
    25 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Thalamus_V3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Sekretariat Endokrinologie, Medical University of Vienna, 0043 14040043100, peter.wolf@meduniwien.ac.at
    Scientific contact
    Sekretariat Endokrinologie, Medical University of Vienna, 0043 14040043100, peter.wolf@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Define the role of leptin action in regulating hepatic VLDL secretion, lipid content and energy metabolism in healthy human subjects
    Protection of trial subjects
    Study days according to standardised operating procedures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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
    Austria: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    47
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was done in the outpatient's department via online advertisement

    Pre-assignment
    Screening details
    		 Inclusion and exclusion criteria: male, aged between 18 and 70 years with plasma triglycerides below 150 mg/dL at screening. In cohort 3, female liver transplant recipients were also eligible. Further inclusion criteria for cohort 3 were: liver transplantation more than 6 months

    Period 1
    Period 1 title
    Healthy subjects (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Metreleptin
    Arm description
    		 active substance (metrelpetin; 0,1 mg/kg/BW) or placebo as single s.c. injection; cross-over design
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metrelepetin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage and administration details: 0,1 mg/kg/BW

    Number of subjects in period 1
    		Metreleptin
    Started
    47
    Completed
    42
    Not completed
    5
         Screening failure
    1
         Adverse event, non-fatal
    1
         Protocol deviation
    2
         Hypertriglyceridemia
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy subjects (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Healthy subjects (overall period) Total
    Number of subjects
    		 47 47
    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)
    		 47 47
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 35 35
    Subject analysis sets

    Subject analysis set title
    Metreleptin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    0,1 mg/kg/BW as a single injection (1x)

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    0,9% NaCl (equal volume), s.c. injection

    Subject analysis sets values
    		 Metreleptin Placebo
    Number of subjects
    42
    42
    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)
    42
    42
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    11
    11
        Male
    31
    31

    End points

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    End points reporting groups
    Reporting group title
    Metreleptin
    Reporting group description
    		 active substance (metrelpetin; 0,1 mg/kg/BW) or placebo as single s.c. injection; cross-over design

    Subject analysis set title
    Metreleptin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    0,1 mg/kg/BW as a single injection (1x)

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    0,9% NaCl (equal volume), s.c. injection

    Primary: VLDL triglyceride secretion rate

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    End point title
    		 VLDL triglyceride secretion rate
    End point description
    Intralipid protocol
    End point type
    Primary
    End point timeframe
    measured 1x / treatment arm
    End point values
    		 Metreleptin Placebo
    Number of subjects analysed
    42
    42
    Units: mg/h
        number (not applicable)
    438
    329
    Statistical analysis title
    		 Paired T-tests
    Statistical analysis description
    Paired T-tests
    Comparison groups
    Metreleptin v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Metreleptin + Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Metreleptin + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Metreleptin + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 47 (2.13%)
    Skin and subcutaneous tissue disorders
    mild anaphylactoid reaction to intralipid infusion
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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/36220067
    http://www.ncbi.nlm.nih.gov/pubmed/40204211
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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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