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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Mounjaro® (tirzepatide) be used in children?
Tirzepatide is not approved for use in pediatric patients. In a phase 3 trial in pediatric participants with T2D, participants on tirzepatide treatment had a greater reduction in HbA1c, fasting serum glucose, and BMI than participants on placebo.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Approved Indication from Prescribing Information
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
Tirzepatide is not approved for use in pediatric patients.
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SURPASS-PEDS Clinical Trial Overview
SURPASS-PEDS is a phase 3, randomized, double-blind, placebo-controlled study with an open-label extension. The study evaluates the safety, efficacy, pharmacokinetics, and pharmacodynamics of once-weekly tirzepatide compared with placebo in pediatric and adolescent patients with T2D. The study duration is approximately 60 weeks.2
The primary outcome is change in glycated hemoglobin (HbA1c) from baseline to week 30.2
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Key Inclusion and Exclusion Criteria
Inclusion Criteria |
Exclusion Criteria |
|
|
Abbreviations: BMI= body mass index; GAD65 = glutamic acid decarboxylase; HbA1c = glycated hemoglobin; IA2 = islet antigen 2; MEN = multiple endocrine neoplasia syndrome type 2 (MEN2); MTC = medullary thyroid carcinoma; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.
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Study Design
SURPASS-PEDS clinical trial included 99 participants from various countries, including Australia, Brazil, India, Israel, Italy, Mexico, the United Kingdom, and the United States.3
The study treatment arms included once weekly subcutaneous injections of
- tirzepatide 5 mg (n=32)
- tirzepatide 10 mg (n=33), and
- placebo (n=34).2
Participants in the experimental arms started with a low dose of tirzepatide, which was increased every four weeks until the maintenance dose was reached. 2
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Baseline Characteristics
|
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Placebo |
Age, years (SD) |
15.0 ± 1.9 |
14.6 ± 1.8 |
14.6 ± 1.8 |
Female, n (%) |
21 (65.6) |
18 (54.5) |
21 (61.8) |
Race, n (%) |
|||
American Indian or Alaska Native |
7 (21.9) |
5 (15.2) |
8 (23.5) |
Asian |
1 (3.1) |
2 (6.1) |
3 (8.8) |
Black or African American |
5 (15.6) |
4 (12.1) |
2 (5.9) |
Multiple |
1 (3.1) |
1 (3.0) |
0 |
White |
17 (53.1) |
19 (57.6) |
21 (61.8) |
Native Hawaiian or Pacific Islander |
1 (3.1) |
2 (6.1) |
0 |
Ethnicity, n (%) |
|||
Hispanic or Latino |
24 (75.0) |
17 (51.5) |
24 (70.6) |
Not Hispanic or Latino |
8 (25.0) |
16 (48.5) |
9 (26.5) |
Not Reported |
0 |
0 |
1 (2.9) |
HbA1c %, mean (SD) |
8.22 ± 1.17 |
7.89 ± 1.22 |
8.02 ± 1.30 |
Abbreviation: HbA1c = glycated hemoglobin.
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Efficacy Results
At 30 weeks, participants on tirzepatide treatment had significantly greater improvements than placebo (all p-values<.01) in the primary and key secondary efficacy outcomes (see SURPASS-PEDS Primary and Key Secondary Efficacy Outcomes).2
Endpoint |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Pooled doses of Tirzepatide (5 mg/10 mg) |
Placebo |
Change in HbA1c %, LSM (SE)a |
-1.90 (± 0.236)b |
-2.16 (± 0.232)b |
-2.03 (± 0.165)b |
-0.23 (± 0.229) |
% Change in BMI, LSM (SE) |
-6.73 (± 1.155)b |
-11.07 (± 1.154)b |
-8.90 (± 0.808)b |
-0.55 (± 1.107) |
Change in BMI, LSM (SE) |
-0.45 (± 0.072)b |
-0.76 (± 0.072)b |
-0.60 (± 0.050)b |
-0.09 (± 0.069) |
Change in FSG (mg/dL), LSM (SE) |
-35.5 (± 7.76)c |
-50.6 (± 7.40)b |
-43.0 (± 5.42)b |
-6.6 (± 7.36) |
HbA1c <7% (%) |
79.6b |
84.5b |
82.1b |
37.4 |
HbA1c ≤6.5% (%) |
66.4b |
80.6b |
73.6b |
28.2 |
HbA1c <5.7% (%) |
44.1c |
56.2b |
50.2b |
15.9 |
Abbreviations: BMI = body mass index; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; LSM = least squares mean.
aPrimary efficacy outcome.
bp<.001 vs placebo.
cp<.01 vs placebo.
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Safety Results
During the placebo-controlled period, one serious adverse event was reported in each treatment arm. The percentage of participants with non-serious adverse events were
- 53.1% on tirzepatide 5mg
- 57.6% on tirzepatide 10 mg, and
- 32.4% on placebo.2
A majority of adverse events with tirzepatide were gastrointestinal-related (see Adverse Events During the Placebo-Controlled Period in SURPASS-PEDS).
Type of Adverse Event, n (%) |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Placebo |
Serious adverse events |
1 (3.1)a |
1 (3.0)b |
1 (2.9)c |
Adverse events causing treatment discontinuation |
2 (6.3) |
0 |
0 |
Non-serious adverse eventd |
17 (53.1) |
19 (57.6) |
11 (32.4) |
Diarrhea |
8 (25.0) |
8 (24.2) |
2 (5.9) |
Nausea |
7 (21.9) |
6 (18.2) |
3 (8.8) |
Vomiting |
5 (15.6) |
4 (12.1) |
1 (2.9) |
Abdominal pain upper |
2 (6.3) |
4 (12.1) |
3 (8.8) |
Abdominal pain |
5 (15.6) |
1 (3.0) |
1 (2.9) |
Dyspepsia |
2 (6.3) |
4 (12.1) |
0 |
Headache |
2 (6.3) |
3 (9.1) |
1 (2.9) |
Oropharyngeal pain |
3 (9.4) |
1 (3.0) |
2 (5.9) |
Cough |
3 (9.4) |
1 (3.0) |
1 (2.9) |
Hyperglycemia |
0 |
0 |
5 (14.7) |
Nasopharyngitis |
1 (3.1) |
2 (6.1) |
2 (5.9) |
Decreased appetite |
0 |
4 (12.1) |
0 |
Anxiety |
1 (3.1) |
2 (6.1) |
0 |
Gastroenteritis |
0 |
0 |
2 (5.9) |
Injection site reaction |
0 |
2 (6.1) |
0 |
Tonsillitis |
2 (6.3) |
0 |
0 |
Abbreviation: SAE = serious adverse event.
aOne patient on tirzepatide 5 mg with the SAE of appendicitis.
bOne patient on tirzepatide 10 mg with the SAE of mastoiditis.
cOne patient on placebo with the SAEs of borderline personality disorder, suicide ideation, and suicide attempt.
dFrequency of ≥ 5%.
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Enclosed Prescribing Information
References
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2A study to evaluate tirzepatide (LY3298176) in pediatric and adolescent participants with type 2 diabetes mellitus inadequately controlled with metformin or basal insulin or both (SURPASS-PEDS). ClinicalTrials.gov identifier: NCT05260021. Updated February 26, 2025. Accessed August 19, 2025. https://clinicaltrials.gov/ct2/show/NCT05260021
3A randomized, double-blind, placebo-controlled, phase 3 study with an open-label extension assessing the efficacy, safety, and pharmacokinetic/pharmacodynamics of tirzepatide in pediatric and adolescent participants with type 2 diabetes mellitus inadequately controlled with metformin, or basal insulin, or both. EU Clinical Trials Register. https://www.clinicaltrialsregister.eu/ctr-search/search?query=GPGV. Accessed August 12, 2025.
Date of Last Review: August 06, 2025