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    Summary
    EudraCT Number:2021-003612-31
    Sponsor's Protocol Code Number:I8F-MC-GPGV
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2024-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-003612-31
    A.3Full title of the trial
    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 (SURPASS-PEDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate Tirzepatide Compared to Placebo in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both
    A.4.1Sponsor's protocol code numberI8F-MC-GPGV
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/311/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTirzepatide
    D.3.2Product code LY3298176
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes Mellitus (T2DM)
    E.1.1.1Medical condition in easily understood language
    Diabetes - type 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that pooled 5 mg and 10 mg tirzepatide once weekly (QW) is superior to placebo at 30 weeks.
    E.2.2Secondary objectives of the trial
    To demonstrate that 5 mg and 10 mg tirzepatide QW, analyzed as pooled and/or separate treatment arms, is superior to placebo at 30 weeks.
    To assess the effect of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 52 weeks.
    To assess safety of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 30 weeks and at the end of the safety follow-up period.
    To compare 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, to
    placebo at 30 weeks.
    To assess the safety of 5 mg and 10 mg tirzepatide QW, analyzed as separate and pooled arms, at 52
    weeks for diabetic retinopathy.
    Characterize the pharmacokinetics and pharmacodynamic relationships of tirzepatide.
    To assess the effect of 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, on patient reported outcomes at 30 and 52 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be 10 to <18 years of age, at the time of signing the informed consent/assent.
    2. Participants have T2DM treated at the time of randomization with lifestyle measures (standardized diet and exercise program), and a. Metformin, or b. Basal insulin, or c. Metformin and basal insulin.
    - If metformin is used, the dose must be ≥1000 mg/day and not more than the locally approved dose
    a. Doses of metformin and basal insulin must have been stable (±15% for basal insulin) for at least 90 days prior to Visit 1 and until Visit 3.
    3. Have HbA1c >6.5% to ≤11% at screening visit (determined by central laboratory).
    4. Body weight ≥50 kg and BMI of >85th percentile of the general age and gender-matched population for that country or region.
    E.4Principal exclusion criteria
    1. Have T1DM.
    2. AFTER the diagnosis of T2DM, have a history of diabetic ketoacidosis or hyperosmolar syndrome.
    3. Have diabetes-associated autoantibodies (GAD65 and/or IA2), historically or at Visit 1.
    4. Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
    5. Have history of: proliferative diabetic retinopathy, or diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment.
    6. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
    7. Had chronic or acute pancreatitis any time prior to study entry (Visit 1).
    8. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than Nonalcoholic fatty liver disease (NAFLD), or ALT or AST level >5.0 times the upper limit of the age-adjusted reference range, or Total bilirubin ≥ 1.5 times the upper limit of the age-adjusted reference range (except in the case of Gilbert’s syndrome) as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this study only if their ALT and AST levels are ≤5.0 times the ULN for the reference range and Total bilirubin level is < 1.5 times the ULN at screening.
    9. Have an estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated by Chronic Kidney
    Disease-Epidemiology as determined by central laboratory at Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    To measure a change in hemoglobin A1c (HbA1c) from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 weeks.
    E.5.2Secondary end point(s)
    Incidence of HbA1c ≤6.5%.
    Change in body mass index (BMI) standard deviation score (age- and sex-matched) from baseline.
    Change in fasting serum glucose (FSG) from baseline.
    Change in HbA1c from baseline.
    Incidence of HbA1c <7.0%.
    Incidence of HbA1c <5.7%.
    Change in daily average 6-point self-monitored blood glucose profiles from baseline.
    Change from baseline for serum lipid levels.
    Incidence of new or worsening of dyslipidemia.
    Treatment-emergent adverse events (TEAEs).
    Discontinuation of study intervention due to adverse events (AEs).
    Adjudicated pancreatic AEs.
    Serum calcitonin.
    Incidence of allergic, hypersensitivity reactions, and injection site reactions.
    Incidence of treatment-emergent anti-drug antibodies to tirzepatide.
    Change in systolic and diastolic blood pressure and heart rate from baseline.
    Incidence of new or worsening of hypertension.
    Incidence of new or worsening of albuminuria.
    Occurrence of hypoglycemic events.
    Incidence of initiation of rescue therapy for severe persistent hyperglycemia.
    Incidence of new or worsening of diabetic neuropathy.
    Change from baseline for physical and developmental measures (Height and weight, Height SDS and weight SDS, Waist circumference, and Tanner Staging).
    Incidence of new or worsening of diabetic retinopathy or diabetic maculopathy in either eye.
    Relationship between tirzepatide exposure and key safety and efficacy measures.
    Change from baseline for PedsQL Generic Core Scales and PedsQL (3.2) Diabetic Module from baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 weeks, 52 weeks and when an AE is reported.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    India
    Israel
    Mexico
    Russian Federation
    United Kingdom
    United States
    France
    Italy
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 90
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 114
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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