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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both.

    Summary
    EudraCT number
    		 2021-003612-31
    Trial protocol
    		 IT   FR  
    Global end of trial date
    28 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2025
    First version publication date
    21 Aug 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I8F-MC-GPGV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05260021
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17121
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    illy Corporate Center, Indianapolis, IN, United States, 46285- 0001
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly, EU_Lilly_Clinical_Trials@lilly.com
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559, EU_Lilly_Clinical_Trials@lilly.com
    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
    28 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.
    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
    13 Apr 2022
    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
    Australia: 2
    Country: Number of subjects enrolled
    Brazil: 16
    Country: Number of subjects enrolled
    India: 6
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Mexico: 31
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    99
    EEA total number of subjects
    3
    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)
    5
    Adolescents (12-17 years)
    94
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Double-blind Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 Milligram (mg) Tirzepatide
    Arm description
    		 Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Arm title
    		 10 mg Tirzepatide
    Arm description
    		 Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
    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
    Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Number of subjects in period 1
    		5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo
    Started
    32
    33
    34
    Received at Least 1 Dose of Study Drug
    32
    33
    34
    Completed
    29
    29
    32
    Not completed
    3
    4
    2
         Consent withdrawn by subject
    1
    2
    1
         Adverse event, non-fatal
    2
    -
    -
         Withdrawal due to Caregiver Circumstances
    -
    1
    -
         Sponsor-Terminated Enrollment Error
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    Period 2
    Period 2 title
    Open-label Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 mg Tirzepatide
    Arm description
    		 Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.

    Arm title
    		 10 mg Tirzepatide
    Arm description
    		 Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period

    Arm title
    		 5 mg Tirzepatide
    Arm description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    articipants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.

    Number of subjects in period 2
    		5 mg Tirzepatide 10 mg Tirzepatide 5 mg Tirzepatide
    Started
    29
    29
    32
    Completed
    29
    29
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5 Milligram (mg) Tirzepatide
    Reporting group description
    		 Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period.

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Reporting group values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Total
    Number of subjects
    		 32 33 34 99
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 15.00 ( 1.93 ) 14.60 ( 1.83 ) 14.60 ( 1.79 ) -
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 21 18 21 60
        Male
    		 11 15 13 39
    Ethnicity (NIH/OMB)
    All randomized participants.
    Units: Subjects
        Hispanic or Latino
    		 24 17 24 65
        Not Hispanic or Latino
    		 8 16 9 33
        Unknown or Not Reported
    		 0 0 1 1
    Race (NIH/OMB)
    All randomized participants.
    Units: Subjects
        American Indian or Alaska Native
    		 7 5 8 20
        Asian
    		 1 2 3 6
        Native Hawaiian or Other Pacific Islander
    		 1 2 0 3
        Black or African American
    		 5 4 2 11
        White
    		 17 19 21 57
        More than one race
    		 1 1 0 2
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        Australia
    		 1 1 0 2
        Brazil
    		 8 5 3 16
        India
    		 1 2 3 6
        Israel
    		 1 4 3 8
        Italy
    		 0 2 1 3
        Mexico
    		 10 8 13 31
        United Kingdom
    		 0 0 1 1
        United States
    		 11 11 10 32
    Percentage of Hemoglobin A1c (HbA1c) at Baseline
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.22 ( 1.17 ) 7.89 ( 1.22 ) 8.02 ( 1.30 ) -

    End points

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    End points reporting groups
    Reporting group title
    5 Milligram (mg) Tirzepatide
    Reporting group description
    		 Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period.

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
    Reporting group title
    5 mg Tirzepatide
    Reporting group description
    		 Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period

    Reporting group title
    5 mg Tirzepatide
    Reporting group description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.

    Subject analysis set title
    Pooled doses of Tirzepatide ( 5mg/10mg )
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.

    Subject analysis set title
    Placebo/5 mg Tirzepatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period were administered with 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.

    Subject analysis set title
    5 mg Tirzepatide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    5 mg Tirzepatide/5 mg Tirzepatide: Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up. Placebo/5 mg Tirzepatide: Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.

    Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)

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    End point title
    		 Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) [1]
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares) (APD): All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication. This analysis was planned to measure the outcome by combining the 5 mg tirzepatide treatment arm and 10 mg tirzepatide treatment arm as pooled doses of tirzepatide (5 mg/10 mg).
    End point type
    Primary
    End point timeframe
    Baseline, Week 30
    Notes
    [1] - 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 performed for this event.
    End point values
    		 Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    32
    56
    Units: percentage of HbA1c
        least squares mean (standard error)
    -0.23 ( 0.229 )
    -2.03 ( 0.165 )
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Pooled doses of Tirzepatide ( 5mg/10mg ), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.35
         upper limit
    		 -1.25

    Secondary: Change From Baseline in HbA1c (Individual Doses)

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    End point title
    		 Change From Baseline in HbA1c (Individual Doses)
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo
    Number of subjects analysed
    29
    27
    32
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.90 ( 0.236 )
    -2.16 ( 0.232 )
    -0.23 ( 0.229 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 5 Milligram (mg) Tirzepatide
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.31
         upper limit
    		 -1.02
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.57
         upper limit
    		 -1.29

    Secondary: Percentage of Participants Who Achieve ≤6.5% of HbA1c

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    End point title
    		 Percentage of Participants Who Achieve ≤6.5% of HbA1c
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if the endpoint measure is missing. Imputed data includes observed value and imputed value if the endpoint measure is missing. APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    32
    33
    34
    65
    Units: percentage of participants
        number (not applicable)
    66.4
    80.6
    28.2
    73.6
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 5 Milligram (mg) Tirzepatide
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    40.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 61.7
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    51.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.1
         upper limit
    		 72.2
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    45.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.5
         upper limit
    		 64.1

    Secondary: Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)

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    End point title
    		 Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)
    End point description
    BMI SDS (age and sex matched), calculated using the World Health Organization (WHO) growth reference standards. BMI is calculated as weight in kilograms divided by height in meters squared (kg/m²) and converted to a Z-score (SDS) based on WHO reference data. A Z-score of 0 represents the population mean for a given age and sex. A BMI SDS between -1 and +1 is considered normal. Obesity is defined as BMI SDS > +2. Reductions in BMI SDS indicate improvement in weight status for individuals with obesity. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares) APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to the study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    29
    29
    34
    58
    Units: Z-score
        least squares mean (standard error)
    -0.45 ( 0.072 )
    -0.76 ( 0.072 )
    -0.09 ( 0.069 )
    -0.60 ( 0.050 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.16
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 -0.47
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 -0.34

    Secondary: Percentage of Participants Who Achieve <7.0% of HbA1c

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    End point title
    		 Percentage of Participants Who Achieve <7.0% of HbA1c
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if the endpoint measure is missing. Imputed data includes observed value and imputed value if the endpoint measure is missing. APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to the study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    32
    33
    34
    65
    Units: percentage of participants
        number (not applicable)
    79.6
    84.5
    37.4
    82.1
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    43.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.3
         upper limit
    		 64.4
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    47.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.4
         upper limit
    		 67.7
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    45.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.3
         upper limit
    		 64.1

    Secondary: Change From Baseline in Fasting Serum Glucose (FSG)

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    End point title
    		 Change From Baseline in Fasting Serum Glucose (FSG)
    End point description
    LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    28
    28
    33
    56
    Units: milligram per deciliter (mg/dL)
        least squares mean (standard error)
    -35.5 ( 7.76 )
    -50.6 ( 7.40 )
    -6.6 ( 7.36 )
    -43.0 ( 5.42 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -28.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.7
         upper limit
    		 -8
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -64.3
         upper limit
    		 -23.6
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -36.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.2
         upper limit
    		 -18.6

    Secondary: Percent Change from Baseline in BMI

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    End point title
    		 Percent Change from Baseline in BMI
    End point description
    LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    29
    29
    34
    58
    Units: Percent Change of BMI
        least squares mean (standard error)
    -6.73 ( 1.155 )
    -11.07 ( 1.154 )
    -0.55 ( 1.107 )
    -8.90 ( 0.808 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -6.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.31
         upper limit
    		 -3.05
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -10.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.67
         upper limit
    		 -7.38
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -8.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.05
         upper limit
    		 -5.66

    Secondary: Percent Change From Baseline for Serum Lipid Levels

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    End point title
    		 Percent Change From Baseline for Serum Lipid Levels
    End point description
    Geometric LS mean was determined by the MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. APD:All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    27
    28
    32
    55
    Units: Percent change
    least squares mean (standard error)
        Serum Cholesterol
    -8.07 ( 2.319 )
    -13.82 ( 2.115 )
    5.07 ( 2.456 )
    -10.99 ( 1.564 )
        Serum HDL Cholesterol 3RD generation, enzymatic
    5.56 ( 3.269 )
    1.72 ( 3.087 )
    0.92 ( 2.887 )
    3.62 ( 2.247 )
        Serum Triglycerides
    -27.6 ( 4.816 )
    -35.8 ( 4.165 )
    -1.74 ( 6.022 )
    -31.8 ( 3.165 )
        Serum LDL Cholesterol Combined
    -6.08 ( 3.870 )
    -11.97 ( 3.540 )
    9.84 ( 4.185 )
    -9.07 ( 2.618 )
        Serum VLDL Cholesterol Combined
    -25.9 ( 5.005 )
    -34.8 ( 4.293 )
    -0.26 ( 6.211 )
    -30.5 ( 3.276 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieve <5.7% of HbA1c

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    End point title
    		 Percentage of Participants Who Achieve <5.7% of HbA1c
    End point description
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Imputed data includes observed value and imputed value if endpoint measure is missing. APD: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    32
    33
    34
    65
    Units: percentage of participants
        number (not applicable)
    44.1
    56.2
    15.9
    50.2
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    29.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 50.3
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    39.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.8
         upper limit
    		 60.2
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    34.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17
         upper limit
    		 52.1

    Secondary: Change From Baseline in Height Standard Deviation Score (SDS)

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    End point title
    		 Change From Baseline in Height Standard Deviation Score (SDS)
    End point description
    Height SDS (age and sex-matched), calculated using the World Health Organization (WHO) growth reference standards. Height SDS is derived by comparing a child's height to the median height for their age and sex in the WHO reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean. A Height SDS below -2 indicates short stature. Positive changes in Height SDS from baseline reflect improvement in growth velocity or catch-up growth. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured APD: randomized participants who received atleast one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    29
    29
    34
    58
    Units: SDS
        least squares mean (standard error)
    -0.092 ( 0.0275 )
    -0.11 ( 0.0274 )
    -0.11 ( 0.0259 )
    -0.100 ( 0.0194 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.708
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.061
         upper limit
    		 0.089
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.976
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.076
         upper limit
    		 0.074
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5 mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.841
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    0.007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.058
         upper limit
    		 0.071

    Secondary: Change From Baseline in Weight SDS

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    End point title
    		 Change From Baseline in Weight SDS
    End point description
    Weight SDS, calculated using Centers for Disease Control and Prevention (CDC) growth reference standards. Weight SDS is derived by comparing a child's weight to median weight for their age and sex in the CDC reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean for a given age and sex. A Weight SDS below -2 may indicate underweight status, while a Weight SDS above +2 may indicate overweight or obesity. Change from baseline Weight SDS reflects shifts in growth trajectory, with positive changes indicating weight gain and negative changes indicating weight reduction. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
    End point type
    Secondary
    End point timeframe
    Baseline, Week 30 APD: All randomized participants who received at least one dose of study drug and had data for this outcome obtained during the double-blind period regardless of adherence to study drug or initiation of rescue antihyperglycemic drug.
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Placebo Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects analysed
    29
    29
    34
    58
    Units: Z-score
        least squares mean (standard error)
    -0.38 ( 0.0600 )
    -0.50 ( 0.0594 )
    -0.099 ( 0.0570 )
    -0.44 ( 0.0422 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    5 mg Tirzepatide, Placebo
    Comparison groups
    5 Milligram (mg) Tirzepatide v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.12
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    10 mg Tirzepatide, Placebo
    Comparison groups
    Placebo v 10 mg Tirzepatide
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Pooled doses of Tirzepatide (5mg/10 mg), Placebo
    Comparison groups
    Placebo v Pooled doses of Tirzepatide ( 5mg/10mg )
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 -0.2

    Secondary: Change From Baseline in PedsQL Generic Core Scale

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    End point title
    		 Change From Baseline in PedsQL Generic Core Scale [2]
    End point description
    The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children (ages 8 to 12) and teenagers (ages 13 to 18). The 23-item PedsQL Generic Core Scale includes physical, emotional, social, and school functioning dimensions. The PedsQL Generic Core yields two summary scores: Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. Each item is scored from 0 (never) to 4 (almost always). Items are reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best). Higher scores indicate better health-related quality of life. LS mean was determined by the MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic Medication + Baseline Age Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    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 performed for this event.
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Pooled doses of Tirzepatide ( 5mg/10mg ) Placebo/5 mg Tirzepatide
    Number of subjects analysed
    29
    27
    56
    26
    Units: score on a scale
    least squares mean (standard error)
        Physical Functioning Score
    4.26 ( 2.034 )
    3.06 ( 2.092 )
    3.66 ( 1.456 )
    5.03 ( 2.142 )
        Emotional Functioning Score
    4.35 ( 3.506 )
    4.11 ( 3.601 )
    4.23 ( 2.514 )
    6.78 ( 3.705 )
        Social Functioning Score
    4.16 ( 2.628 )
    3.00 ( 2.696 )
    3.58 ( 1.878 )
    4.54 ( 2.764 )
        School Functioning Score
    13.30 ( 3.095 )
    0.18 ( 3.152 )
    6.74 ( 2.197 )
    12.03 ( 3.239 )
        Psychosocial Health Summary Score
    7.82 ( 2.482 )
    2.20 ( 2.533 )
    5.01 ( 1.767 )
    7.47 ( 2.605 )
        Physical Health Summary Score
    4.26 ( 2.034 )
    3.06 ( 2.092 )
    3.66 ( 1.456 )
    5.03 ( 2.142 )
        Total Score
    6.65 ( 2.114 )
    2.45 ( 2.163 )
    4.55 ( 1.507 )
    6.61 ( 2.220 )
    No statistical analyses for this end point

    Secondary: Change From Baseline PedsQL (3.2) Diabetic Module

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    End point title
    		 Change From Baseline PedsQL (3.2) Diabetic Module [3]
    End point description
    The PedsQL 3.2 Diabetes Module has 33 items for ages 13 to 45 years and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms, treatment barriers, treatment adherence, worry and communication. Scores range from 0 to 100. Higher scores indicate fewer problems. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance- Covariance structure (Change from Baseline) = Unstructured. APD:All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind, open-label, and safety follow-up periods regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    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 performed for this event.
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide Pooled doses of Tirzepatide ( 5mg/10mg ) Placebo/5 mg Tirzepatide
    Number of subjects analysed
    29
    27
    56
    25
    Units: score on a scale
    least squares mean (standard error)
        Diabetes Management Summary Score
    7.21 ( 2.669 )
    8.60 ( 2.733 )
    7.90 ( 1.907 )
    5.25 ( 2.872 )
        Total Score
    8.79 ( 2.310 )
    8.74 ( 2.374 )
    8.76 ( 1.657 )
    6.03 ( 2.489 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide [4]
    End point description
    PK: AUCss of Tirzepatide APD:All randomized participants who received at least one dose of study drug and had evaluable PK data obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    End point type
    Secondary
    End point timeframe
    Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.
    Notes
    [4] - 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 performed for this event.
    End point values
    		 5 Milligram (mg) Tirzepatide 10 mg Tirzepatide
    Number of subjects analysed
    32
    31
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (confidence interval 95%)
    92100 (85700 to 98600)
    184000 (171000 to 197000)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to Week 56
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    TZP 5mg / Double-Blind Period
    Reporting group description
    		 Participants received 5 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.

    Reporting group title
    TZP 10mg / Double-Blind Period
    Reporting group description
    		 Participants received 10 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.

    Reporting group title
    Placebo / Double-Blind Period
    Reporting group description
    		 Participants received placebo QW administered as SC injection via SDP for 30 weeks in a double-blind period.

    Reporting group title
    Placebo/TZP 5mg/ Open-Label and Safety Follow-Up Period
    Reporting group description
    		 Participants who received placebo QW during the double-blind period were switched to 5 mg tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.

    Reporting group title
    TZP 5mg /5 mg Open-Label and Safety Follow-Up Period
    Reporting group description
    		 Participants who received 5 mg tirzepatide during the double-blind period continued to receive 5 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.

    Reporting group title
    TZP 10mg /10 mg Open-Label and Safety Follow-Up Period
    Reporting group description
    		 Participants who received 10 mg of tirzepatide during the double-blind period continued to receive 10 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.

    Serious adverse events
    		 TZP 5mg / Double-Blind Period TZP 10mg / Double-Blind Period Placebo / Double-Blind Period Placebo/TZP 5mg/ Open-Label and Safety Follow-Up Period TZP 5mg /5 mg Open-Label and Safety Follow-Up Period TZP 10mg /10 mg Open-Label and Safety Follow-Up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Hepatobiliary disorders
    Cholecystitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    borderline personality disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mastoiditis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TZP 5mg / Double-Blind Period TZP 10mg / Double-Blind Period Placebo / Double-Blind Period Placebo/TZP 5mg/ Open-Label and Safety Follow-Up Period TZP 5mg /5 mg Open-Label and Safety Follow-Up Period TZP 10mg /10 mg Open-Label and Safety Follow-Up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 32 (53.13%)
    19 / 33 (57.58%)
    11 / 34 (32.35%)
    8 / 32 (25.00%)
    10 / 32 (31.25%)
    7 / 33 (21.21%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 33 (9.09%)
    1 / 34 (2.94%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    0 / 33 (0.00%)
         occurrences all number
    7
    5
    1
    1
    4
    0
    General disorders and administration site conditions
    injection site reaction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    0
    Pyrexia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    5 / 32 (15.63%)
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    5
    1
    1
    0
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 33 (12.12%)
    3 / 34 (8.82%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    18
    4
    4
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    7 / 32 (21.88%)
    6 / 33 (18.18%)
    3 / 34 (8.82%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
         occurrences all number
    27
    7
    3
    0
    3
    0
    diarrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    8 / 32 (25.00%)
    8 / 33 (24.24%)
    2 / 34 (5.88%)
    6 / 32 (18.75%)
    5 / 32 (15.63%)
    1 / 33 (3.03%)
         occurrences all number
    23
    11
    7
    13
    6
    1
    dyspepsia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 33 (12.12%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 33 (12.12%)
    1 / 34 (2.94%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
         occurrences all number
    7
    24
    1
    3
    1
    2
    Abdominal discomfort
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [1]
    0 / 21 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    8
    0
    Respiratory, thoracic and mediastinal disorders
    oropharyngeal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 33 (3.03%)
    2 / 34 (5.88%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
         occurrences all number
    4
    1
    3
    0
    2
    3
    cough
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
         occurrences all number
    4
    1
    2
    0
    2
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    2 / 34 (5.88%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    3 / 33 (9.09%)
         occurrences all number
    1
    2
    3
    1
    3
    3
    gastroenteritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    5 / 34 (14.71%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    0
    decreased appetite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 32 (0.00%)
    4 / 33 (12.12%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

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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
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