SURPASS-PEDS

CompletedPhase 3Results posted

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

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05260021

Org study ID17121

Secondary ID2021-003612-31

Secondary IDI8F-MC-GPGVEli Lilly and Company

Timeline

Milestones

Study first posted2022-03-02actual

Study start2022-04-13actual

Primary completion2024-07-30actual

Study completion2025-01-28actual

Last update posted2025-09-26actual

Results first posted2025-09-26actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Cardiometabolic biomarkers

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

6 endpoints

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)

Time frame:Baseline, Week 30

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Z-score	95% CI
5 mg Tirzepatide	-0.45	—
10 mg Tirzepatide	-0.76	—
Pooled Doses of Tirzepatide (5mg,10mg)	-0.60	—
Placebo	-0.09	—

LS Mean difference (Final Values)-0.3695% CI-0.55 – -0.16p< 0.001ANCOVA

LS Mean difference (Final Values)-0.6695% CI-0.86 – -0.47p<0.001ANCOVA

LS Mean difference (Final Values)-0.5195% CI-0.68 – -0.34p< 0.001ANCOVA

Secondary/registry result

Percent Change From Baseline in BMI

Time frame:Baseline, Week 30

BMI, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change of BMI	95% CI
5 mg Tirzepatide	-6.73	—
10 mg Tirzepatide	-11.07	—
Pooled Doses of Tirzepatide (5mg,10mg)	-8.90	—
Placebo	-0.55	—

LS Mean difference (Final Values)-6.1895% CI-9.31 – -3.05p< 0.001ANCOVA

LS Mean difference (Final Values)-10.5295% CI-13.67 – -7.38p< 0.001ANCOVA

LS Mean difference (Final Values)-8.3595% CI-11.05 – -5.66p< 0.001ANCOVA

Secondary/registry result

Change From Baseline in Weight SDS

Time frame:Baseline, Week 30

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Z-score	95% CI
5 mg Tirzepatide	-0.38	—
10 mg Tirzepatide	-0.50	—
Pooled Doses of Tirzepatide (5mg,10mg)	-0.44	—
Placebo	-0.099	—

LS Mean difference (Final Values)-0.2995% CI-0.45 – -0.12p< 0.001Mixed Models Analysis

LS Mean difference (Final Values)-0.495% CI-0.57 – -0.24p< 0.001Mixed Models Analysis

LS Mean difference (Final Values)-0.3495% CI-0.49 – -0.2p< 0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)

Time frame:Baseline, Week 30

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in BMI

Time frame:Baseline, Week 30

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Weight SDS

Time frame:Baseline, Week 30

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)

Time frame:Baseline, Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Pooled Doses of Tirzepatide (5 mg, 10 mg)	-2.03	—
Placebo	-0.23	—

LS Mean difference (Final Values)-1.8095% CI-2.35 – -1.25p<0.001ANCOVA

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)

Time frame:Baseline, Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c (Individual Doses)

Time frame:Baseline, Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
5 mg Tirzepatide	-1.90	—
10 mg Tirzepatide	-2.16	—
Placebo	-0.23	—

LS Mean difference (Final Values)-1.6795% CI-2.31 – -1.02p<0.001ANCOVA

LS Mean difference (Final Values)-1.9395% CI-2.57 – -1.29p<0.001ANCOVA

Secondary/registry result

Percentage of Participants Who Achieve ≤6.5% of HbA1c

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	66.4	—
10 mg Tirzepatide	80.6	—
Pooled Doses of Tirzepatide (5mg,10mg)	73.6	—
Placebo	28.2	—

Risk Difference (RD)40.195% CI18.6 – 61.7p<0.001Regression, Logistic

Risk Difference (RD)51.695% CI31.1 – 72.2p<0.001Regression, Logistic

Risk Difference (RD)45.895% CI27.5 – 64.1p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram per deciliter (mg/dL)	95% CI
5 mg Tirzepatide	-35.5	—
10 mg Tirzepatide	-50.6	—
Pooled Doses of Tirzepatide (5mg,10mg)	-43.0	—
Placebo	-6.6	—

LS Mean difference (Final Values)-28.995% CI-49.7 – -8.0p0.007ANCOVA

LS Mean difference (Final Values)-44.095% CI-64.3 – -23.6p< 0.001ANCOVA

LS Mean difference (Final Values)-36.495% CI-54.2 – -18.6p< 0.001ANCOVA

Secondary/registry result

Percentage of Participants Who Achieve <5.7% of HbA1c

Time frame:Week 30

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	44.1	—
10 mg Tirzepatide	56.2	—
Pooled Doses of Tirzepatide (5mg,10mg)	50.2	—
Placebo	15.9	—

Risk Difference (RD)29.595% CI8.6 – 50.3p0.006Regression, Logistic

Risk Difference (RD)39.595% CI18.8 – 60.2p< 0.001Regression, Logistic

Risk Difference (RD)34.695% CI17 – 52.1p< 0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve <7.0% of HbA1c

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	79.6	—
10 mg Tirzepatide	84.5	—
Pooled Doses of Tirzepatide (5mg,10mg)	82.1	—
Placebo	37.4	—

Risk Difference (RD)43.495% CI22.3 – 64.4p< 0.001Regression, Logistic

Risk Difference (RD)47.195% CI26.4 – 67.7p< 0.001Regression, Logistic

Risk Difference (RD)45.295% CI26.3 – 64.1p< 0.001Regression, Logistic

Secondary/protocol endpoint

Change From Baseline in HbA1c (Individual Doses)

Time frame:Baseline, Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≤6.5% of HbA1c

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Who Achieve <5.7% of HbA1c

Time frame:Week 30

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve <7.0% of HbA1c

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Percent Change From Baseline for Serum Lipid Levels

Time frame:Baseline, Week 30

percent change from baseline, improvement

Posted result

Group	Value (geometric_least_squares_mean), Percent change of Serum Lipid Levels	95% CI
5 mg TirzepatideSerum Cholesterol	-8.07	—
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic	5.56	—
Serum Triglycerides	-27.6	—
Serum low-density lipoprotein (LDL) Cholesterol Combined	-6.08	—
Serum very low-density lipoprotein (VLDL) Cholesterol Combined	-25.9	—
10 mg TirzepatideSerum Cholesterol	-13.82	—
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic	1.72	—
Serum Triglycerides	-35.8	—
Serum low-density lipoprotein (LDL) Cholesterol Combined	-11.97	—
Serum very low-density lipoprotein (VLDL) Cholesterol Combined	-34.8	—
Pooled Doses of Tirzepatide (5mg,10mg)Serum Cholesterol	-10.99	—
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic	3.62	—
Serum Triglycerides	-31.8	—
Serum low-density lipoprotein (LDL) Cholesterol Combined	-9.07	—
Serum very low-density lipoprotein (VLDL) Cholesterol Combined	-30.5	—
PlaceboSerum Cholesterol	5.07	—
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic	0.92	—
Serum Triglycerides	-1.74	—
Serum low-density lipoprotein (LDL) Cholesterol Combined	9.84	—
Serum very low-density lipoprotein (VLDL) Cholesterol Combined	-0.26	—

Secondary/protocol endpoint

Percent Change From Baseline for Serum Lipid Levels

Time frame:Baseline, Week 30

percent change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	95% CI
5 mg TirzepatidePhysical Functioning Score	4.26	—
Emotional Functioning Score	4.35	—
Social Functioning Score	4.16	—
School Functioning Score	13.30	—
Psychosocial Health Summary Score	7.82	—
Physical Health Summary Score	4.26	—
Total Score	6.65	—
10 mg TirzepatidePhysical Functioning Score	3.06	—
Emotional Functioning Score	4.11	—
Social Functioning Score	3.00	—
School Functioning Score	0.18	—
Psychosocial Health Summary Score	2.20	—
Physical Health Summary Score	3.06	—
Total Score	2.45	—
Placebo/5 mg TirzepatidePhysical Functioning Score	5.03	—
Emotional Functioning Score	6.78	—
Social Functioning Score	4.54	—
School Functioning Score	12.03	—
Psychosocial Health Summary Score	7.47	—
Physical Health Summary Score	5.03	—
Total Score	6.61	—
Pooled Doses of Tirzepatide (5mg,10mg)Physical Functioning Score	3.66	—
Emotional Functioning Score	4.23	—
Social Functioning Score	3.58	—
School Functioning Score	6.74	—
Psychosocial Health Summary Score	5.01	—
Physical Health Summary Score	3.66	—
Total Score	4.55	—

Secondary/registry result

Change From Baseline PedsQL (3.2) Diabetic Module

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	95% CI
5 mg TirzepatideDiabetes Management Summary Score	7.21	—
Total Score	8.79	—
10 mg TirzepatideDiabetes Management Summary Score	8.60	—
Total Score	8.74	—
Placebo/5 mg TirzepatideDiabetes Management Summary Score	5.25	—
Total Score	6.03	—
Pooled Doses of Tirzepatide (5mg,10mg)Diabetes Management Summary Score	7.90	—
Total Score	8.76	—

Secondary/protocol endpoint

Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline PedsQL (3.2) Diabetic Module

Time frame:Baseline, Week 52

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

Time frame:Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramhour per milliliter (nghr/mL)	95% CI
5 mg Tirzepatide	92100	85700 – 98600
10 mg Tirzepatide	184000	171000 – 197000

Secondary/protocol endpoint

Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

Time frame:Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.

AUC₀–∞

concentration, descriptive

Other clinical outcomes

2 endpoints

Secondary/registry result

Change From Baseline in Height Standard Deviation Score (SDS)

Time frame:Baseline, Week 30

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), Z-score	95% CI
5 mg Tirzepatide	-0.092	—
10 mg Tirzepatide	-0.11	—
Pooled Doses of Tirzepatide (5mg,10mg)	-0.100	—
Placebo	-0.11	—

LS Mean difference (Final Values)0.01495% CI-0.061 – 0.089p0.708Mixed Models Analysis

LS Mean difference (Final Values)-0.00195% CI-0.076 – 0.074p0.976Mixed Models Analysis

LS Mean difference (Final Values)0.00795% CI-0.058 – 0.071p0.841Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Height Standard Deviation Score (SDS)

Time frame:Baseline, Week 30

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet (London, England)2025 Oct 4PMID40975112doi:10.1016/S0140-6736(25)01774-Xvia clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.