Phase 3 · Tirzepatide

SURPASS-PEDS trial results

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

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) (percentage of HbA1c), Baseline, Week 30. Pooled Doses of Tirzepatide (5 mg, 10 mg): -2.03; Placebo: -0.23.

Participants: 99
Status: completed
Completed: 2025-01-28
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05260021), updated at source Sep 26, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SURPASS-PEDS measured first

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)percentage of HbA1c · Baseline, Week 30 · least squares mean

Pooled Doses of Tirzepatide (5 mg, 10 mg)n=56	Placebon=32
-2.03(0.165)	-0.23(0.229)

Side effects by arm

Side effects in SURPASS-PEDS

Percent of participants affected, Baseline Up to Week 56. The most common events the registry lists.

Event	5 mg Tirzepatide / Double-Blind Period	TZP 10mg / Double-Blind Period	Placebo / Double-Blind Period	TZP 5mg / 5mg Open-Label and Safety Follow-Up Period	TZP 10mg / 10mg Open-Label and Safety Follow-Up Period	Placebo/TZP 5mg Open-Label and Safety Follow-Up Period
Any serious event	3.1%	3%	2.9%	3.1%	3%	0%
Diarrhoea	25%	24.2%	5.9%	15.6%	3%	18.8%
Nausea	21.9%	18.2%	8.8%	6.3%	0%	0%
Abdominal pain	15.6%	3%	2.9%	0%	0%	0%
Vomiting	15.6%	12.1%	2.9%	3.1%	6.1%	3.1%
Hyperglycaemia	0%	0%	14.7%	0%	0%	0%
Abdominal pain upper	6.3%	12.1%	8.8%	0%	0%	0%
Dyspepsia	6.3%	12.1%	0%	0%	0%	0%
Decreased appetite	0%	12.1%	0%	0%	0%	0%
Dysmenorrhoea	0%	0%	0%	9.5%	0%	0%
Headache	6.3%	9.1%	2.9%	9.4%	0%	3.1%
Cough	9.4%	3%	2.9%	6.3%	0%	0%
Oropharyngeal pain	9.4%	3%	5.9%	6.3%	3%	0%
Nasopharyngitis	3.1%	6.1%	5.9%	6.3%	9.1%	3.1%
Tonsillitis	6.3%	0%	0%	0%	0%	0%
Abdominal discomfort	0%	0%	0%	0%	0%	6.3%
Pyrexia	0%	0%	0%	6.3%	3%	0%
Upper respiratory tract infection	0%	0%	0%	3.1%	0%	6.3%
Injection site reaction	0%	6.1%	0%	0%	0%	0%
Anxiety	3.1%	6.1%	0%	0%	0%	0%
Gastroenteritis	0%	0%	5.9%	0%	0%	0%

Secondary outcomes

What else it measured

Change From Baseline in HbA1c (Individual Doses)percentage of HbA1c · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=29	10 mg Tirzepatiden=27	Placebon=32
-1.90(0.236)	-2.16(0.232)	-0.23(0.229)

Percentage of Participants Who Achieve ≤6.5% of HbA1cpercentage of participants · Week 30 · number

5 mg Tirzepatiden=32	10 mg Tirzepatiden=33	Pooled Doses of Tirzepatide (5mg,10mg)n=65	Placebon=34
66.4	80.6	73.6	28.2

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)Z-score · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=29	10 mg Tirzepatiden=29	Pooled Doses of Tirzepatide (5mg,10mg)n=58	Placebon=34
-0.45(0.072)	-0.76(0.072)	-0.60(0.050)	-0.09(0.069)

Change From Baseline in Fasting Serum Glucose (FSG)milligram per deciliter (mg/dL) · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=28	10 mg Tirzepatiden=28	Pooled Doses of Tirzepatide (5mg,10mg)n=56	Placebon=33
-35.5(7.76)	-50.6(7.40)	-43.0(5.42)	-6.6(7.36)

Percent Change From Baseline in BMIPercent Change of BMI · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=29	10 mg Tirzepatiden=29	Pooled Doses of Tirzepatide (5mg,10mg)n=58	Placebon=34
-6.73(1.155)	-11.07(1.154)	-8.90(0.808)	-0.55(1.107)

Percentage of Participants Who Achieve <5.7% of HbA1cpercentage of participants · Week 30 · number

5 mg Tirzepatiden=32	10 mg Tirzepatiden=33	Pooled Doses of Tirzepatide (5mg,10mg)n=65	Placebon=34
44.1	56.2	50.2	15.9

Percentage of Participants Who Achieve <7.0% of HbA1cpercentage of participants · Week 30 · number

5 mg Tirzepatiden=32	10 mg Tirzepatiden=33	Pooled Doses of Tirzepatide (5mg,10mg)n=65	Placebon=34
79.6	84.5	82.1	37.4

Percent Change From Baseline for Serum Lipid LevelsPercent change of Serum Lipid Levels · Baseline, Week 30 · geometric least squares mean

Measure	5 mg Tirzepatiden=27	10 mg Tirzepatiden=28	Pooled Doses of Tirzepatide (5mg,10mg)n=55	Placebon=32
Serum Cholesterol	-8.07(2.319)	-13.82(2.115)	-10.99(1.564)	5.07(2.456)
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic	5.56(3.269)	1.72(3.087)	3.62(2.247)	0.92(2.887)
Serum Triglycerides	-27.6(4.816)	-35.8(4.165)	-31.8(3.165)	-1.74(6.022)
Serum low-density lipoprotein (LDL) Cholesterol Combined	-6.08(3.870)	-11.97(3.540)	-9.07(2.618)	9.84(4.185)
Serum very low-density lipoprotein (VLDL) Cholesterol Combined	-25.9(5.005)	-34.8(4.293)	-30.5(3.276)	-0.26(6.211)

Change From Baseline in Height Standard Deviation Score (SDS)Z-score · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=29	10 mg Tirzepatiden=29	Pooled Doses of Tirzepatide (5mg,10mg)n=58	Placebon=34
-0.092(0.0275)	-0.11(0.0274)	-0.100(0.0194)	-0.11(0.0259)

Change From Baseline in Weight SDSZ-score · Baseline, Week 30 · least squares mean

5 mg Tirzepatiden=29	10 mg Tirzepatiden=29	Pooled Doses of Tirzepatide (5mg,10mg)n=58	Placebon=34
-0.38(0.0600)	-0.50(0.0594)	-0.44(0.0422)	-0.099(0.0570)

Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scalescore on a scale · Baseline, Week 52 · least squares mean

Measure	5 mg Tirzepatiden=29	10 mg Tirzepatiden=27	Placebo/5 mg Tirzepatiden=25	Pooled Doses of Tirzepatide (5mg,10mg)n=56
Physical Functioning Score	4.26(2.034)	3.06(2.092)	5.03(2.142)	3.66(1.456)
Emotional Functioning Score	4.35(3.506)	4.11(3.601)	6.78(3.705)	4.23(2.514)
Social Functioning Score	4.16(2.628)	3.00(2.696)	4.54(2.764)	3.58(1.878)
School Functioning Score	13.30(3.095)	0.18(3.152)	12.03(3.239)	6.74(2.197)
Psychosocial Health Summary Score	7.82(2.482)	2.20(2.533)	7.47(2.605)	5.01(1.767)
Physical Health Summary Score	4.26(2.034)	3.06(2.092)	5.03(2.142)	3.66(1.456)
Total Score	6.65(2.114)	2.45(2.163)	6.61(2.220)	4.55(1.507)

Change From Baseline PedsQL (3.2) Diabetic Modulescore on a scale · Baseline, Week 52 · least squares mean

Measure	5 mg Tirzepatiden=29	10 mg Tirzepatiden=27	Placebo/5 mg Tirzepatiden=25	Pooled Doses of Tirzepatide (5mg,10mg)n=56
Diabetes Management Summary Score	7.21(2.669)	8.60(2.733)	5.25(2.872)	7.90(1.907)
Total Score	8.79(2.310)	8.74(2.374)	6.03(2.489)	8.76(1.657)

The trial

How SURPASS-PEDS was run

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.

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
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
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.

Who could join the trial

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.

Published papers

Papers from SURPASS-PEDS

Hannon TS, Chao LC, Barrientos-Perez M, Pamidipati KC, Lando LF, Lee CJ, Patel H, Bergman BK. 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. 2025 Oct 4;406(10511):1484-1496. doi: 10.1016/S0140-6736(25)01774-X. Epub 2025 Sep 17.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.