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    Clinical Trial Results:
    A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 years to 11 years) with Obesity.

    Summary
    EudraCT number
    		 2024-000081-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2025
    First version publication date
    31 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I8F-MC-GPHV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05696847
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Clinical Trial Registry Office, Eli Lilly and Company, 1 877‐CTLilly, EU_Lilly_Clinical_Trials@lilly.com
    Scientific contact
    Clinical Trial Registry Office, Eli Lilly and Company, 1 877‐285‐4559, EU_Lilly_Clinical_Trials@lilly.com
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly, ClinicalTrials.gov@lilly.com
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559, ClinicalTrials.gov@lilly.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002360-PIP02-22
    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
    16 Jan 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Feb 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    28
    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)
    28
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 NA

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Screening Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Placebo (BW >=50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight of at least 50 kg, received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 2: Placebo (BW <50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight less than 50 kg, received placebo administered SC QW during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 3: Placebo (BW 40 to 60 kg)
    Arm description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Arm description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Number of subjects in period 1
    		Cohort 1: Placebo (BW >=50 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Started
    3
    6
    2
    7
    3
    7
    Completed
    2
    6
    2
    7
    3
    7
    Not completed
    1
    0
    0
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -
    -
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Placebo (BW >=50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 2: Placebo (BW <50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Arm description
    		 Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 3: Placebo (BW 40 to 60 kg)
    Arm description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Arm description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    Other name
    LY3298176
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 was only screening period and not the baseline period. Period 2 (Treatment Period) was added as the baseline period per planned analysis.
    Number of subjects in period 2 [2]
    		Cohort 1: Placebo (BW >=50 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Started
    2
    6
    2
    7
    3
    7
    Received At Least One Dose of Study Drug
    2
    6
    2
    7
    3
    7
    Completed
    2
    5
    2
    6
    3
    6
    Not completed
    0
    1
    0
    1
    0
    1
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    1
         Withdrawal by Parent/Guardian
    -
    1
    -
    -
    -
    -
         Sponsor Decision
    -
    -
    -
    1
    -
    -
    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: Subjects reported in treatment period (considered as baseline period) are 27. 1 subject from the 28 enrolled subjects, discontinued the study in the screening period prior to receiving any treatment and was not included in the treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Placebo (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.

    Reporting group title
    Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 2: Placebo (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 3: Placebo (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group values
    		 Cohort 1: Placebo (BW >=50 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) Total
    Number of subjects
    		 2 6 2 7 3 7 27
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 2 6 2 7 3 7 27
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 3 2 5 2 4 17
        Male
    		 1 3 0 2 1 3 10
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 2 0 2 5
        Not Hispanic or Latino
    		 2 5 2 5 3 5 22
        Unknown or Not Reported
    		 0 0 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0
        Asian
    		 0 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islande
    		 0 0 0 0 0 0 0
        Black or African American
    		 1 4 2 2 1 4 14
        White
    		 1 2 0 5 2 3 13
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 2 6 2 7 3 7 27

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Placebo (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.

    Reporting group title
    Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight of at least 50 kg, received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 2: Placebo (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 3: Placebo (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
    Reporting group title
    Cohort 1: Placebo (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.

    Reporting group title
    Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 2: Placebo (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 3: Placebo (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Primary: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

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    End point title
    		 Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) [1]
    End point description
    Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is reported in the Reported Adverse Events section in this record. Analysis Population Description (APD): All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline Up To 14 Weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this end point.
    End point values
    		 Cohort 1: Placebo (BW >=50 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Number of subjects analysed
    2
    6
    2
    7
    3
    7
    Units: Percentage of Participants
    number (not applicable)
        TEAE
    0
    83.3
    0
    85.7
    33.3
    100
        SAE
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide [2]
    End point description
    PK: AUC0-tau of tirzepatide APD: All participants who received at least one dose of tirzepatide and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inferential statistics was planned for this end point.
    End point values
    		 Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Number of subjects analysed
    6
    7
    7
    Units: nanogram *hour per milliliter
        arithmetic mean (standard deviation)
    105000 ( 33100 )
    80800 ( 9580 )
    156000 ( 22500 )
    No statistical analyses for this end point

    Secondary: PK: Maximum Concentration (Cmax) of Tirzepatide

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    End point title
    		 PK: Maximum Concentration (Cmax) of Tirzepatide [3]
    End point description
    PK: Cmax of tirzepatide APD: All participants who received at least one dose of tirzepatide and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inferential statistics was planned for this end point.
    End point values
    		 Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Number of subjects analysed
    6
    7
    7
    Units: nanograms per milliliter
        arithmetic mean (standard deviation)
    884 ( 243 )
    674 ( 63.8 )
    1280 ( 194 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 14 Weeks
    Adverse event reporting additional description
    All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Cohort 1: Placebo (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight of at least 50 kg, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 2: 1.25-2.5 mg tirzepatide QW (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg, received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 3: Placebo (BW 40 to 60 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.

    Reporting group title
    Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight of at least 50 kg, received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

    Reporting group title
    Cohort 2: Placebo (BW <50 kg)
    Reporting group description
    		 Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.

    Serious adverse events
    		 Cohort 1: Placebo (BW >=50 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) Cohort 2: 1.25-2.5 mg tirzepatide QW (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Placebo (BW >=50 kg) Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) Cohort 2: 1.25-2.5 mg tirzepatide QW (BW <50 kg) Cohort 3: Placebo (BW 40 to 60 kg) Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) Cohort 2: Placebo (BW <50 kg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    7 / 7 (100.00%)
    6 / 7 (85.71%)
    1 / 3 (33.33%)
    5 / 6 (83.33%)
    0 / 2 (0.00%)
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    headache
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    injection site erythema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    pyrexia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 7 (57.14%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    9
    2
    5
    0
    0
    constipation
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    diarrhoea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 7 (42.86%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    7
    0
    0
    1
    0
    dyspepsia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    eructation
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    flatulence
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    5 / 7 (71.43%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    7
    2
    0
    3
    0
    vomiting
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    6 / 7 (85.71%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    11
    1
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    solar dermatitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    pollakiuria
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    myalgia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infections and infestations
    gastroenteritis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    otitis media
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    pneumonia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    3
    0
    hypoglycaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2023
    - Updated schema to reflect body weight range for Cohort 3; - Modified rationale and text to include body weight range in Cohort 3.

    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
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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
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