Phase 3 N=99 Randomized Double-blind Treatment

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

Type2 Diabetes · Diabetes Mellitus · Diabetes Mellitus, Type 2 · T2D · T2DM (Type 2 Diabetes Mellitus)

Bottom Line

View on ClinicalTrials.gov: NCT05260021 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Sep 2025

Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) — -2.03; -0.23 percentage of HbA1c — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tirzepatide Dose 1 (Drug); Tirzepatide Dose 2 (Drug); Placebo (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)	-2.03; -0.23	<0.001 sig
SECONDARY Change From Baseline in HbA1c (Individual Doses)	-1.90; -2.16; -0.23	<0.001 sig
SECONDARY Percentage of Participants Who Achieve ≤6.5% of HbA1c	66.4; 80.6; 73.6; 28.2	<0.001 sig
SECONDARY Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)	-0.45; -0.76; -0.60; -0.09	< 0.001 sig
SECONDARY Change From Baseline in Fasting Serum Glucose (FSG)	-35.5; -50.6; -43.0; -6.6	0.007 sig
SECONDARY Percent Change From Baseline in BMI	-6.73; -11.07; -8.90; -0.55	< 0.001 sig
SECONDARY Percentage of Participants Who Achieve <5.7% of HbA1c	44.1; 56.2; 50.2; 15.9	0.006 sig
SECONDARY Percentage of Participants Who Achieve <7.0% of HbA1c	79.6; 84.5; 82.1; 37.4	< 0.001 sig
SECONDARY Percent Change From Baseline for Serum Lipid Levels	-8.07; -13.82; -10.99; 5.07; 5.56; 1.72	—
SECONDARY Change From Baseline in Height Standard Deviation Score (SDS)	-0.092; -0.11; -0.100; -0.11	0.708
SECONDARY Change From Baseline in Weight SDS	-0.38; -0.50; -0.44; -0.099	< 0.001 sig
SECONDARY Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale	4.26; 3.06; 5.03; 3.66; 4.35; 4.11	—
SECONDARY Change From Baseline PedsQL (3.2) Diabetic Module	7.21; 8.60; 5.25; 7.90; 8.79; 8.74	—
SECONDARY Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide	92100; 184000	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05260021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.