If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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.
What is the efficacy and safety of Mounjaro® (tirzepatide) in pediatric patients with type 2 diabetes?
In a phase 3 trial in pediatric participants aged 10 to <18 years with T2D, tirzepatide treatment had greater reduction in HbA1c, FSG, and BMI than placebo. Adverse events were mostly consistent with those observed in adults with T2D.
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 and pediatric patients 10 years of age and older with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
The safety and effectiveness of tirzepatide have not been established in pediatric patients less than 10 years of age.1
Back to →Content Overview
SURPASS-PEDS Clinical Trial Overview
SURPASS-PEDS was a phase 3, randomized, double-blind, parallel arm, placebo-controlled study with an open-label extension. The study evaluated the safety and efficacy of once-weekly tirzepatide (5 and 10 mg) compared with placebo in pediatric and adolescent patients with T2D inadequately controlled with metformin and/or basal insulin.2
Back to →Content Overview
Key Inclusion and Exclusion Criteria
Inclusion Criteria |
Key Exclusion Criteria |
|
|
Abbreviations: BMI = body mass index; BP = blood pressure; DBP = diastolic blood pressure; GAD65 = glutamic acid decarboxylase; GI = gastrointestinal; HbA1c = glycated hemoglobin; IA2 = islet antigen 2; MEN2 = multiple endocrine neoplasia syndrome type 2; MTC = medullary thyroid carcinoma; SBP = systolic blood pressure; T1D = type 1 diabetes; T2D = type 2 diabetes.
Back to →Content Overview
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.2
Participants were randomly assigned (1:1:1) to one of the study treatment arms, which 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 2.5 mg of tirzepatide for 4 weeks, and then the dose was escalated by 2.5 mg increments every 4 weeks until the assigned maintenance dose was reached. A maximum dose of 10 mg was selected based on pharmacokinetic (PK) and pharmacodynamic (PD) modelling, which predicted adult-equivalent exposure and clinically meaningful glycemic efficacy in pediatric participants weighing ≥50 kg.2
The primary outcome of the study was change in glycated hemoglobin (HbA1c) from baseline to week 30 for pooled tirzepatide doses (5 mg and 10 mg) compared with placebo.2
The study included a 30-week period followed by an open-label extension through week 52, during which all participants received tirzepatide (SURPASS-PEDS Study Design).2
SURPASS-PEDS Study Design presents an overview of the study design and the dose escalation strategy for tirzepatide.
Figure 1 description: SURPASS-PEDS was a phase 3, 52-week, double-blind, parallel arm, placebo-controlled study in pediatric and adolescent patients with type 2 diabetes inadequately controlled with metformin and/or basal insulin, where participants were randomized in a 1:1:1 ratio to receive tirzepatide (5 mg or 10 mg) or placebo once weekly subcutaneously. Tirzepatide-treated participants started at a 2.5 mg dose and followed a dose escalation regimen (escalated in 2.5 mg increments every 4 weeks) until the assigned dose was reached.
Abbreviations: QW = once weekly; PBO = placebo; TZP = tirzepatide; V= visit.
Back to →Content Overview
Baseline Characteristics
|
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Pooled Tirzepatide |
Placebo |
Age, years (SD) |
15.0±1.9 |
14.6±1.8 |
14.8±1.9 |
14.6±1.8 |
Age category, n (%) |
||||
≥10 to ≤14 years |
13 (41) |
15 (45) |
28 (43) |
16 (47) |
≥15 to <18 years |
19 (59) |
18 (55) |
37 (57) |
18 (53) |
Duration of diabetes, years |
2.5±1.6 |
1.9±1.3 |
2.2±1.5 |
2.7±2.3 |
Female, n (%) |
21 (66) |
18 (55) |
39 (60) |
21 (62) |
Race, n (%) |
||||
American Indian or Alaska Native |
7 (22) |
5 (15) |
12 (18) |
8 (24) |
Asian |
1 (3) |
2 (6) |
3 (5) |
3 (9) |
Black or African American |
5 (16) |
4 (12) |
9 (14) |
2 (6) |
Multiple |
1 (3) |
1 (3) |
2 (3) |
0 |
White |
17 (53) |
19 (58) |
36 (55) |
21 (62) |
Missing |
1 (3) |
1 (3) |
2 (3) |
0 |
Diabetes therapy at baseline, n (%) |
||||
Basal insulin only |
3 (9) |
3 (9) |
6 (9) |
2 (6) |
Metformin + basal insulin |
7 (22) |
8 (24) |
15 (23) |
8 (24) |
Metformin only |
22 (69) |
22 (67) |
44 (68) |
24 (71) |
FSG concentration, mg/dL (SD) |
147.8±52.3 |
151.6±68.3 |
149.8±60.9 |
156.1±77.8 |
Lipid profiles at baseline, mg/dL (SE) |
||||
Total cholesterol |
165.7±7.66 |
155.1±6.81 |
160.3±5.11 |
169.5±7.33 |
HDL |
37.9±1.79 |
36.5±1.64 |
37.2±1.21 |
39.9±1.77 |
Triglycerides |
156.5±18.82 |
144.8±16.6 |
150.5±12.49 |
144.9±16.31 |
LDL |
89.9±6.22 |
83.7±5.50 |
86.7±4.14 |
95.6±6.19 |
VLDL |
30.4±3.44 |
28.7±3.08 |
29.5±2.30 |
28.4±3.00 |
HbA1c %, mean (SD) |
8.22±1.17 |
7.89±1.22 |
8.05±1.20 |
8.02±1.30 |
BMI, kg/m2 (SD) |
33.9±7.2 |
37.7±8.4 |
35.8±8.0 |
34.7±7.7 |
Abbreviations: BMI = body mass index; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; HDL = high-density lipoprotein; LDL = low-density lipoprotein; VLDL = very low-density lipoprotein.
Back to →Content Overview
Efficacy Results
At 30 weeks, participants on tirzepatide treatment had significantly greater improvements than placebo (all p values<.01) in the primary outcome of mean change from baseline in HbA1c, as well as key secondary outcomes, such as mean changes from baseline in fasting serum glucose and BMI (see SURPASS-PEDS Primary and Other Efficacy Outcomes at Week 30).2
Two statistical estimands, efficacy or treatment-regimen, were used to evaluate efficacy data from this phase 3 clinical trial of tirzepatide. Efficacy estimand evaluates the treatment effect prior to discontinuation of the study drug without confounding effects of antihyperglycemic rescue therapy. Treatment-regimen estimand evaluates the treatment effect irrespective of adherence to the study drug or initiation of rescue antidiabetic drugs. Differences in reported data may reflect the application of these estimands. This response presents data reflecting the efficacy estimand. For treatment-regimen estimand results, please refer to the manuscript cited and/or the US prescribing information, where applicable.2
Endpoint using efficacy estimanda |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Pooled Doses of Tirzepatide (5 mg/10 mg) |
Placebo |
Change in HbA1c % |
||||
LSM |
-2.16 |
-2.30 |
-2.23 |
0.05 |
ETD vs placebo (95% CI) |
NA |
|||
% Change in BMIc |
||||
LSM |
-7.41 |
-11.20 |
-9.30 |
-0.37 |
ETD vs placebo (95% CI) |
-7.04 (-10.48 to -3.60)b |
-10.82 (-14.25 to -7.39)b |
-8.93 (-11.91 to -5.95)b |
NA |
Change in BMI-SDSc |
||||
LSM |
-0.50 |
-0.76 |
-0.63 |
-0.09 |
ETD vs placebo (95% CI) |
-0.41 (-0.62 to -0.19)e |
-0.67 (-0.88 to -0.45)b |
-0.54 (-0.72 to -0.35)b |
NA |
Change in FSG (mg/dL)c |
||||
LSM |
-35.0 |
-53.5 |
-44.2 |
-7.9 |
ETD vs placebo (95% CI) |
-27.0 (-48.9 to -5.21)f |
-45.6 (-66.7 to -24.5)b |
-36.3 (-55.0 to -17.6)e |
NA |
HbA1c <7%g (%) |
84.2h |
91.5h |
87.9h |
34.3 |
HbA1c ≤6.5%c (%) |
70.8h |
86.1h |
78.6h |
27.8 |
HbA1c <5.7%g (%) |
46.9i |
59.6h |
53.4h |
14.4 |
Lipids, change from baselineg |
||||
Triglycerides (%) |
-27.6 |
-35.8 |
-31.8 |
-1.74 |
Total cholesterol (%) |
-8.1 |
-13.8 |
-11.0 |
5.1 |
HDL (%) |
5.56 |
1.72 |
3.62 |
0.92 |
LDL (%) |
-6.08 |
-11.97 |
-9.07 |
9.84 |
Abbreviations: BMI = body mass index; ETD = estimated treatment difference; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; LSM = least squares mean, HDL = high density lipoprotein, LDL = low density lipoprotein; SDS = standard deviation score.
aThe efficacy estimand represents the average treatment effect of tirzepatide relative to placebo, excluding data after discontinuation of treatment or initiation of glycemic rescue therapy.
bp<.0001 vs placebo.
cKey secondary outcome controlled for type 1 error.
dPrimary efficacy outcome.
ep<.0003 vs placebo.
fp<.016 vs placebo.
gEndpoints were not controlled for Type 1 error.
hp<.001 vs placebo.
ip<.01 vs placebo.
Figures Percent Change in HbA1c From Baseline Over 52 Weeks and Change in BMI-SDS From Baseline Over 52 Weeks present HbA1c and body mass index (BMI) standard-deviation score changes from week 0 through 52 weeks, including the open-label period.
Figure 2 description: Through 52 weeks, treatment with tirzepatide resulted in mean reductions in HbA1c of 2.10% and 2.32% observed for the 5 mg and 10 mg doses, respectively. Data are presented based on the efficacy estimand.
aPBO/TZP 5 mg represents participants receiving PBO in the double-blind period and TZP 5 mg treatment in the open-label period.
Abbreviations: HbA1c = glycated hemoglobin; PBO = placebo; TZP = tirzepatide.
Figure 3 description: Treatment with tirzepatide, both pooled (-0.87) and individual dose groups (5 mg -0.66; 10 mg -1.08), resulted in reductions in BMI-SDS from baseline to week 52.
aPBO/TZP 5 mg represents participants receiving PBO in the double-blind period and TZP 5 mg treatment in the open-label period.
Abbreviations: BMI-SDS = body mass index standard-deviation score; PBO= placebo; TZP = tirzepatide.
Back to →Content Overview
Safety Results
The incidence of adverse reactions reported in pediatric patients treated with tirzepatide 5 mg and 10 mg were consistent with those observed in adult patients with T2D with the exception of a higher incidence of vomiting, abdominal pain, and hypoglycemia.1
During the placebo-controlled period, one serious adverse event was reported in each treatment arm. The percentage of participants with any adverse events were
- 66% on tirzepatide 5 mg
- 70% on tirzepatide 10 mg, and
- 44% on placebo.2
Most adverse events with tirzepatide were gastrointestinal-related (see Adverse Events During the Placebo-Controlled Period in SURPASS-PEDS at Week 30) and occurred mostly during dose escalation and decreased over time. All events were mild or moderate in severity across all treatment groups, with no severe cases of nausea or vomiting.2
Type of Adverse Event, n (%) |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Pooled Tirzepatide |
Placebo |
Any adverse event |
21 (66) |
23 (70) |
44 (68) |
15 (44) |
Serious adverse events |
1 (3)a |
1 (3)b |
2 (3) |
1 (3)c |
Adverse events causing treatment discontinuation |
2 (6)d |
0 |
2 (3) |
0 |
Adverse events occurring in ≥5% in any treatment group |
||||
Diarrhea |
8 (25) |
8 (24) |
16 (25) |
2 (6) |
Nausea |
7 (22) |
6 (18) |
13 (20) |
3 (9) |
Vomiting |
5 (16) |
4 (12) |
9 (14) |
1 (3) |
Abdominal pain upper |
2 (6) |
4 (12) |
6 (9) |
3 (9) |
Abdominal pain |
5 (16) |
1 (3) |
6 (9) |
1 (3) |
Dyspepsia |
2 (6) |
4 (12) |
6 (9) |
0 |
Headache |
2 (6) |
3 (9) |
5 (8) |
1 (3) |
Oropharyngeal pain |
3 (9) |
1 (3) |
4 (6) |
2 (6) |
Cough |
3 (9) |
1 (3) |
4 (6) |
1 (3) |
Hyperglycemia |
0 |
0 |
0 |
5 (15) |
Nasopharyngitis |
1 (3) |
2 (6) |
3 (5) |
2 (6) |
Decreased appetite |
0 |
4 (12) |
4 (6) |
0 |
Anxiety |
1 (3) |
2 (6) |
3 (5) |
0 |
Gastroenteritis |
0 |
0 |
0 |
2 (6) |
Injection site reaction |
0 |
2 (6) |
2 (3) |
0 |
Tonsillitis |
2 (6) |
0 |
2 (3) |
0 |
Hypoglycemia |
||||
Severe hypoglycemia (Level 3), n (%) |
0 |
0 |
0 |
0 |
Blood glucose <54 mg/dL (Level 2), n (%) [rate/yr] |
5 (16) [1.11] |
5 (15) [0.51] |
10 (15) [0.81] |
2 (6) [0.15] |
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.
dOne participant due to nausea, one participant due to suicidal ideation.
During the open-label period and subsequent safety follow-up, 3 participants experienced serious adverse events:
- 2 participants receiving tirzepatide 5 mg reported cholecystitis and appendicitis, respectively, and
- 1 participant on tirzepatide 10 mg experienced mastoiditis, and 31 days after the last dose of study drug, reported depression and a suicide attempt.2
Back to →Content Overview
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Hannon TS, Chao LC, Barrientos-Pérez M, et al. 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;406(10511):1484-1496. https://doi.org/10.1016/S0140-6736(25)01774-X
Date of Last Review: December 01, 2025