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)

• ClinicalTrials.gov Identifier: NCT05260021
• Recruitment Status: Active, not recruiting
• First Posted: March 2, 2022
• Last Update Posted: April 11, 2024
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: February 25, 2022
• First Posted Date: March 2, 2022
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: April 13, 2022
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 25, 2022): Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 30 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 25, 2022)

• Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 30 ]
• Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched) [ Time Frame: Baseline, Week 30 ]
• Change From Baseline in Fasting Serum Glucose (FSG) [ Time Frame: Baseline, Week 30 ]
• Percentage of Participants Who Achieve ≤6.5% of HbA1c [ Time Frame: Week 30 ]
• Percentage of Participants Who Achieve <7.0% of HbA1c [ Time Frame: Week 30 ]
• Percentage of Participants Who Achieve <5.7% of HbA1c [ Time Frame: Week 30 ]
• Change From Baseline for Serum Lipid Levels [ Time Frame: Baseline, Week 30 ]
• Change From Baseline in Height Standard Deviation Score (SDS) [ Time Frame: Baseline, Week 30 ]
• Change From Baseline in Weight SDS [ Time Frame: Baseline, Week 30 ]
• Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide [ Time Frame: Baseline to Week 30 ]
• Change From Baseline in PedsQL Generic Core Scale [ Time Frame: Baseline, Week 52 ]
  The PedsQL Generic Core Scale has 23 items that measure the core dimensions of health: physical, emotional, and social and school functioning. Scores range from 0 to 100. Higher scores indicate better health related quality of life.
• Change From Baseline PedsQL (3.2) Diabetic Module [ Time Frame: Baseline, Week 52 ]
  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 less problems.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Type2 Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2D
• T2DM (Type 2 Diabetes Mellitus)
• Glucose Metabolism Disorders
• Endocrine System Diseases
• Metabolic Disease

Intervention

• Drug: Tirzepatide Dose 1
  Administered SC
• Drug: Tirzepatide Dose 2
  Administered SC
• Drug: Placebo
  Administered SC

Study Arms

• Experimental: Tirzepatide Dose 1

  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

  Intervention: Drug: Tirzepatide Dose 1
• Experimental: Tirzepatide Dose 2

  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

  Intervention: Drug: Tirzepatide Dose 2
• Placebo Comparator: Placebo

  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.

  Interventions:

  • Drug: Tirzepatide Dose 1
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 27, 2024): 99
• Original Estimated Enrollment (submitted: February 25, 2022): 90
• Estimated Study Completion Date: February 2025
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female, aged 10 to below 18 years at screening visit
• Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
• Have HbA1c >6.5% to ≤11% at screening
• Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.

Exclusion Criteria:

• Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
• After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
• Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• Had chronic or acute pancreatitis any time prior to study entry
• Female participants who are pregnant or breast feeding or intending to become pregnant.
• Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Brazil, France, India, Israel, Italy, Mexico, United Kingdom, United States
• Removed Location Countries: Russian Federation, Spain

Administrative Information

• NCT Number: NCT05260021
• Other Study ID Numbers: 17121; I8F-MC-GPGV ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: http://vivli.org/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: 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

• PRS Account: Eli Lilly and Company
• Verification Date: April 2024