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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
Must not have
After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
Had chronic or acute pancreatitis any time prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52
Awards & highlights

Summary

This trial is testing tirzepatide, a medication that helps control blood sugar levels, in children and teenagers with type 2 diabetes. These participants are already taking other diabetes medications like metformin or basal insulin. Tirzepatide works by helping the body use insulin more effectively and reducing sugar production in the liver. Tirzepatide is a new medication being tested for its effectiveness and safety in people with type 2 diabetes.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had diabetic ketoacidosis or hyperosmolar syndrome after being diagnosed with type 2 diabetes.
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I have had pancreatitis before.
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I am not pregnant, breastfeeding, or planning to become pregnant.
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I have Type 1 diabetes or positive for specific diabetes antibodies.
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I've had a severe low blood sugar episode or didn't notice my low blood sugar at least once in the last 6 months.
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I or my family have a history of MTC or MEN2.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change From Baseline PedsQL (3.2) Diabetic Module
Change From Baseline in PedsQL Generic Core Scale

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%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for type 2 diabetes include GLP-1 receptor agonists and dual GIP and GLP-1 receptor agonists like Tirzepatide. GLP-1 receptor agonists work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which helps to lower blood glucose levels and promote weight loss. Tirzepatide, a dual GIP and GLP-1 receptor agonist, combines these effects with additional benefits from GIP receptor activation, potentially offering superior glycemic control and weight loss. These mechanisms are crucial for diabetes patients as they address multiple aspects of the disease, improving overall metabolic health and reducing the risk of complications.
Cardiovascular effects of GLP-1 receptor agonism.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.[Significance of combination therapy with an insulin sensitizer and a DPP-4(dipeptidyl peptidase-4) inhibitor].

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,545 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
~29 spots leftby Sep 2025
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