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Tirzepatide for Pediatric Type 2 Diabetes (SURPASS-PEDS Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Male or female, aged 10 to below 18 years at screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52
Awards & highlights

SURPASS-PEDS Trial Summary

This trial is testing the safety and effectiveness of tirzepatide compared to placebo in children and adolescents with type 2 diabetes who are also taking metformin, basal insulin, or both. The study will last 60 weeks with 14 clinic visits and 6 phone visits.

Who is the study for?
This trial is for children and teenagers aged 10 to under 18 with type 2 diabetes, who are already taking metformin or basal insulin. They should have a stable dose for at least 90 days prior to screening, an HbA1c level over 6.5% but not above 11%, weigh at least 50 kg (110 pounds), and have a BMI above the 85th percentile for their age and gender.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Tirzepatide in two different doses compared to a placebo in young patients with type 2 diabetes inadequately controlled by metformin or basal insulin. It involves around sixty weeks of participation, including up to fourteen clinic visits and six phone calls.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with diabetes medications like Tirzepatide may include low blood sugar levels, nausea, diarrhea, abdominal pain, increased heart rate, headache, fatigue among others.

SURPASS-PEDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 110 pounds and my BMI is in the top 15% for my age and gender.
Select...
I am between 10 and 17 years old.

SURPASS-PEDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change From Baseline PedsQL (3.2) Diabetic Module
Change From Baseline for Serum Lipid Levels
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
+9 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

SURPASS-PEDS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tirzepatide Dose 2Experimental Treatment1 Intervention
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
Group II: Tirzepatide Dose 1Experimental Treatment1 Intervention
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
Group III: PlaceboPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,830 Total Patients Enrolled
11 Trials studying Diabetes
15,619 Patients Enrolled for Diabetes
1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company

Media Library

Diabetes Research Study Groups: Tirzepatide Dose 2, Tirzepatide Dose 1, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients would best be suited for this kind of medical research?

"This clinical study is looking for 90 participants, all of whom must be between 10 and 18 years of age. Furthermore, all potential subjects must have diabetes mellitus and meet the following other conditions: the individual must be male or female, have a body weight of at least 50 kilograms or 110 pounds, have a BMI in the 85th percentile or higher for their age and gender demographic, be treated with diet and exercise as well as metformin and/or basal insulin (dosage must be stable for at least 90 days before screening for the study), and finally have an HbA1c level at or above 6.5%"

Answered by AI

Are people of all ages being accepted for this test, or are there age restrictions?

"This particular trial is only seeking patients who are aged between 10-18 years old. Out of the 1215 trials that are available for patients over the age of 65, this is one of 235 trials for patients under 18."

Answered by AI

Has the FDA cleared Tirzepatide Dose 2 for public consumption?

"There is some clinical evidence to support the efficacy of tirzepatide dose 2, as well as extensive data backing its safety, so it received a score of 3."

Answered by AI

Might there still be room for more people in this research project?

"The trial appears to be ongoing, with the most recent update taking place on October 18th, 2020. It was originally posted on April 13th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Missouri
How old are they?
18 - 65
< 18
What site did they apply to?
Washington University
Consano Clinical Research, LLC
Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05260021.
All > Diabetes Type 2
~11 spots leftby Aug 2024
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