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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGV | Other Identifier | Eli Lilly and Company | |
| 2021-003612-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide Dose 1 | Experimental | Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
|
| Tirzepatide Dose 2 | Experimental | Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
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| Placebo | Placebo Comparator | Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide Dose 1 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) | 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) | Baseline, Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Individual Doses) | 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). | Baseline, Week 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Center Of Excellence in Diabetes and Endocrinology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40975112 | Derived | Hannon TS, Chao LC, Barrientos-Perez M, Pamidipati KC, Lando LF, Lee CJ, Patel H, Bergman BK. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025 Oct 4;406(10511):1484-1496. doi: 10.1016/S0140-6736(25)01774-X. Epub 2025 Sep 17. |
| Label | URL |
|---|---|
| A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 Milligram (mg) Tirzepatide/5 mg Tirzepatide | 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 and 22 weeks in open-label period with an additional 4 weeks of safety follow-up. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period (30 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2021 | Jun 12, 2025 |
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| Tirzepatide Dose 2 |
| Drug |
Administered SC |
|
| Placebo | Drug | Administered SC |
|
| Percentage of Participants Who Achieve ≤6.5% of HbA1c | 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. | Week 30 |
| Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched) | 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 the ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares) | Baseline, Week 30 |
| Change From Baseline in Fasting Serum Glucose (FSG) | LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). | Baseline, Week 30 |
| Percent Change From Baseline in BMI | LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). | Baseline, Week 30 |
| Percentage of Participants Who Achieve <5.7% of HbA1c | 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. | Week 30 |
| Percentage of Participants Who Achieve <7.0% of HbA1c | 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. | Week 30 |
| Percent Change From Baseline for Serum Lipid Levels | 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. | Baseline, Week 30 |
| Change From Baseline in Height Standard Deviation Score (SDS) | 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 | Baseline, Week 30 |
| Change From Baseline in Weight SDS | 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 | Baseline, Week 30 |
| Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | 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. | Baseline, Week 52 |
| Change From Baseline PedsQL (3.2) Diabetic Module | The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry [2 items (3 for teens and adults)] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. 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. | Baseline, Week 52 |
| Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide | The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group. | 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. |
| Sacramento |
| California |
| 95821 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Touro University California | Vallejo | California | 94592 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Nemours Children's Health - Delaware | Wilmington | Delaware | 19803 | United States |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| AA Medical Research Center | Flint | Michigan | 48504 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Centre for Children's Health Research | Brisbane | Queensland | 4101 | Australia |
| Perth Children's Hospital | Perth | Western Australia | 6009 | Australia |
| CEDOES | Vitória | Espírito Santo | 29055450 | Brazil |
| Centro de Diabetes Curitiba | Curitiba | Paraná | 80810-040 | Brazil |
| Instituto Méderi de Pesquisa e Saúde | Passo Fundo | Rio Grande do Sul | 99010-120 | Brazil |
| Instituto da Crianca com Diabetes | Porto Alegre | Rio Grande do Sul | 91350-250 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | São Paulo | 13034-685 | Brazil |
| Instituto de Pesquisa clinica de Campinas | Campinas | São Paulo | 13060-080 | Brazil |
| Instituto de Pesquisa Clinica | São Paulo | São Paulo | 01223-001 | Brazil |
| Instituto da Crianca do Hospital das Clinicas da FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro | 22270-060 | Brazil |
| CPQuali Pesquisa Clínica | São Paulo | 01228-000 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| Centre Hospitalier Universitaire d'Angers | Angers | Maine-et-Loire | 49933 | France |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T | Paris | 75019 | France |
| Gujarat Endocrin Pvt Ltd | Ahmedabad | Gujarat | 380052 | India |
| M S Ramaiah Medical College and Hospitals | Bangalore | Karnataka | 560054 | India |
| Bhakti Vedanta Hospital and Research Institute | Thane | Maharashtra | 401107 | India |
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Kovai Diabetes Speciality Center and Hospital | Coimbatore | Tamil Nadu | 641009 | India |
| Postgraduate Institute of Medical Education & Research | Chandigarh | 160012 | India |
| Yitzhak Shamir Medical Center | Be’er Ya‘aqov | Central District | 70300 | Israel |
| Sheba Medical Center | Ramat Gan | Central District | 5262100 | Israel |
| Shaare Zedek Medical Center | Jerusalem | Jerusalem | 9013102 | Israel |
| Rambam Health Care Campus | Haifa | Northern District | 3109601 | Israel |
| Soroka Medical Center | Beersheba | Southern District | 8410101 | Israel |
| Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T | Naples | Campania | 80138 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento | Verona | Veneto | 37126 | Italy |
| Ospedale Pediatrico Salesi | Ancona | 60123 | Italy |
| Unidad Médica para la Salud Integral | San Nicolás de los Garza | Nuevo León | 66465 | Mexico |
| Clínica Cemain | Tampico | Tamaulipas | 89170 | Mexico |
| Investigacion En Salud Y Metabolismo Sc | Chihuahua City | 31217 | Mexico |
| Consultorio Médico de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91910 | Mexico |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Hull Royal Infirmary | Hull | Kingston Upon Hull | HU3 2JZ | United Kingdom |
| Leicester General Hospital | Leicester | Leicestershire | LE5 4PW | United Kingdom |
| 10 mg Tirzepatide/10 mg Tirzepatide |
Participants received 10 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. |
| FG002 | 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. |
| Received Atleast One Dose of Study Drug |
|
| Safety Analysis Set 1 | Safety Analysis set 1 is defined as, data obtained from mITT participants (those who took at least 1 dose of study intervention was included in the analyses) during Double blind period, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication. |
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| COMPLETED |
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| NOT COMPLETED |
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| Open-label Period (22 Weeks) |
|
| Safety Follow-up Period (4 Weeks) |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| BG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| BG002 | Placebo | Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hemoglobin A1c | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | Percentage of HbA1c |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) | 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) | 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). | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 30 |
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| Secondary | Change From Baseline in HbA1c (Individual Doses) | 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). | 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. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 30 |
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| Secondary | Percentage of Participants Who Achieve ≤6.5% of HbA1c | 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. | 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. | Posted | Number | percentage of participants | Week 30 |
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| Secondary | Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched) | 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 the ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares) | 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. | Posted | Least Squares Mean | Standard Error | Z-score | Baseline, Week 30 |
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| Secondary | Change From Baseline in Fasting Serum Glucose (FSG) | LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). | 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. | Posted | Least Squares Mean | Standard Error | milligram per deciliter (mg/dL) | Baseline, Week 30 |
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| Secondary | Percent Change From Baseline in BMI | LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares). | 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. | Posted | Least Squares Mean | Standard Error | Percent Change of BMI | Baseline, Week 30 |
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| Secondary | Percentage of Participants Who Achieve <5.7% of HbA1c | 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. | 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. | Posted | Number | percentage of participants | Week 30 |
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| Secondary | Percentage of Participants Who Achieve <7.0% of HbA1c | 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. | 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. | Posted | Number | percentage of participants | Week 30 |
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| Secondary | Percent Change From Baseline for Serum Lipid Levels | 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. | 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. | Posted | Geometric Least Squares Mean | Standard Error | Percent change of Serum Lipid Levels | Baseline, Week 30 |
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| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) | 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 | 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. | Posted | Least Squares Mean | Standard Error | Z-score | Baseline, Week 30 |
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| Secondary | Change From Baseline in Weight SDS | 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 | 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. | Posted | Least Squares Mean | Standard Error | Z-score | Baseline, Week 30 |
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| Secondary | Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline PedsQL (3.2) Diabetic Module | The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry [2 items (3 for teens and adults)] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide | The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group. | 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. | Posted | Mean | 95% Confidence Interval | nanogram*hour per milliliter (ng*hr/mL) | 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. |
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Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts.
Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5 mg Tirzepatide / Double-Blind Period | Participants received 5 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period. | 0 | 32 | 1 | 32 | 17 | 32 |
| EG001 | TZP 10mg / Double-Blind Period | Participants received 10 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period. | 0 | 33 | 1 | 33 | 19 | 33 |
| EG002 | Placebo / Double-Blind Period | Participants received placebo QW administered as SC injection via SDP for 30 weeks in a double-blind period. | 0 | 34 | 1 | 34 | 11 | 34 |
| EG003 | TZP 5mg / 5mg Open-Label and Safety Follow-Up Period | 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. | 0 | 32 | 1 | 32 | 10 | 32 |
| EG004 | TZP 10mg / 10mg Open-Label and Safety Follow-Up Period | 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. | 0 | 33 | 1 | 33 | 7 | 33 |
| EG005 | Placebo/TZP 5mg Open-Label and Safety Follow-Up Period | 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. | 0 | 32 | 0 | 32 | 8 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Mastoiditis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Borderline personality disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2025 | Jun 12, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Brazil |
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| India |
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| Israel |
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| Italy |
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| Mexico |
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| United Kingdom |
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| United States |
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| Placebo |
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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| OG002 | Pooled Doses of Tirzepatide (5mg,10mg) | Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| OG003 | Placebo | Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
|
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| Placebo |
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
|
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| Placebo |
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
|
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| Placebo |
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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| OG003 |
| Placebo |
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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| OG003 | Placebo | Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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|
| OG002 | Pooled Doses of Tirzepatide (5mg,10mg) | Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| OG003 | Placebo | Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
|
|
|
Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| OG002 | Pooled Doses of Tirzepatide (5mg,10mg) | Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
| OG003 | Placebo | Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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| OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period |
| OG002 | Placebo/5 mg Tirzepatide | 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. |
| OG003 | Pooled Doses of Tirzepatide (5mg,10mg) | Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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| 10 mg Tirzepatide |
Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period |
| OG002 | Placebo/5 mg Tirzepatide | 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. |
| OG003 | Pooled Doses of Tirzepatide (5mg,10mg) | Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period. |
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