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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05260021 |
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Recruitment Status :
Active, not recruiting
First Posted : March 2, 2022
Last Update Posted : April 11, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 T2D T2DM (Type 2 Diabetes Mellitus) Glucose Metabolism Disorders Endocrine System Diseases Metabolic Disease | Drug: Tirzepatide Dose 1 Drug: Tirzepatide Dose 2 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 99 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 13, 2022 |
| Estimated Primary Completion Date : | August 2024 |
| Estimated Study Completion Date : | February 2025 |
| Arm | Intervention/treatment |
|---|---|
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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 |
Drug: Tirzepatide Dose 1
Administered SC |
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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 |
Drug: Tirzepatide Dose 2
Administered SC |
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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. |
Drug: Tirzepatide Dose 1
Administered SC Drug: Placebo Administered SC |
- Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 30 ]
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260021
Show 54 study locations
| 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 |
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT05260021 |
| Other Study ID Numbers: |
17121 I8F-MC-GPGV ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | March 2, 2022 Key Record Dates |
| Last Update Posted: | April 11, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (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 Statistical Analysis Plan (SAP) 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/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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GLP-1 RA Glucose-dependent insulinotropic polypeptide (GIP) glucagon-like peptide-1 (GLP-1) GIP/GLP-1 dual receptor agonist Incretins |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases |
Tirzepatide Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |