Mounjaro (Tirzepatide) Significantly Improves A1C in Pediatric Type 2 Diabetes: Phase 3 Trial Results.

SURPASS-PEDS demonstrated that Mounjaro achieved the primary and all key secondary endpoints at 30 weeks, with continued glycemic control and BMI reduction observed through the 52-week extension.

Mounjaro’s safety and tolerability profile in the study remained consistent with prior trials involving adult populations.

Eli Lilly and Company (LLY) unveiled comprehensive results from the SURPASS-PEDS trial, a Phase 3 study assessing Mounjaro (tirzepatide) in pediatric patients (ages 10-17) with type 2 diabetes. The study, presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 and published in *The Lancet*, revealed Mounjaro’s superior performance in lowering A1C and body mass index (BMI) compared to placebo after 30 weeks. Mounjaro, a dual GIP/GLP-1 receptor agonist, holds promise for a demographic where traditional treatments such as metformin and basal insulin often prove insufficient.

Dr. Tamara Hannon, director of the Clinical Diabetes Program at Indiana University School of Medicine and lead SURPASS-PEDS investigator, emphasized the aggressiveness of type 2 diabetes in young patients and the limitations of currently available therapies. “The SURPASS-PEDS results highlight Mounjaro’s ability to deliver substantial enhancements in blood sugar management, BMI reduction, and fasting serum glucose levels in younger individuals affected by this intricate condition,” Dr. Hannon stated. This suggests that Mounjaro could reshape the trajectory of long-term health outcomes for young individuals managing this condition.

The trial met its primary endpoint by demonstrating a statistically significant A1C reduction of 2.2 percentage points from a baseline of 8.05% in patients receiving Mounjaro (pooled doses) versus placebo. A key secondary endpoint showed that 86.1% of subjects in the 10 mg Mounjaro arm achieved an A1C target of ≤6.5%. Furthermore, Mounjaro demonstrated significant improvements in BMI, a critical metric for monitoring weight management in children and adolescents throughout development. At the 30-week mark, BMI decreased by an average of 11.2% in the 10 mg Mounjaro cohort. Improvements in A1C and BMI were sustained throughout the 52-week study extension, supporting continued effectiveness.

Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health, noted the urgency of addressing the rise of type 2 diabetes in children and adolescents. “Type 2 diabetes in children and teens is increasing at an alarming rate, yet treatment options are limited, and this patient population remains underserved,” said Custer. “The SURPASS-PEDS results show Mounjaro delivered statistically significant improvements in A1C, BMI and other critical cardiometabolic risk factors, while maintaining a safety profile generally consistent with adult studies. By undertaking this research, we can better support children and adolescents living with this condition.” Custer’s remarks highlight the significant potential of Mounjaro in tackling the challenges faced by this demographic.

Regarding safety, the profile of Mounjaro in SURPASS-PEDS was generally in line with the incretin class and prior data. Most adverse events, including diarrhea, nausea, and vomiting, were mild to moderate and primarily occurred during dose escalation. Treatment discontinuation rates due to adverse events were low. Lilly has submitted the SURPASS-PEDS results to global regulatory agencies, seeking a label expansion for Mounjaro to include this younger population.

**Market Outlook and Analyst Perspective:**
The SURPASS-PEDS data is likely to bolster confidence in Mounjaro’s potential within the broader diabetes and weight management market. Given the increasing prevalence of type 2 diabetes among youth, regulatory approval could unlock a significant growth opportunity for Lilly. Analysts at Jefferies have previously noted the strong clinical profile of tirzepatide, particularly its impact on weight loss, and project multi-billion dollar peak sales. The pediatric indication, if approved, would add further upside to these projections, positioning Lilly as a leader in innovative diabetes care. Investors will be closely watching regulatory decisions from the FDA and other global agencies.

About tirzepatide
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) dual receptor agonist. Tirzepatide is a single molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones. Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Tirzepatide decreases calorie intake, and the effects are likely mediated by affecting appetite. Tirzepatide lowers fasting and postprandial glucose, increases insulin sensitivity, decreases food intake and reduces body weight in patients with type 2 diabetes. Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are ongoing.

Tirzepatide has been approved by the U.S. FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control, and as Zepbound for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Tirzepatide is also approved as Mounjaro in some countries outside the U.S. for adults with type 2 diabetes, obesity or those who are overweight who also have a weight-related comorbid condition. Both Mounjaro and Zepbound should be used in combination with diet and exercise.

About SURPASS-PEDS
SURPASS-PEDS (NCT05260021) is a regulator-required, Phase 3, multicenter, randomized, double-blind, placebo-controlled, trial with an open-label extension evaluating the efficacy, safety and pharmacokinetics of Mounjaro (tirzepatide) in children and adolescents (ages 10 to less than 18) with type 2 diabetes inadequately controlled with metformin, basal insulin or both. The trial randomized 99 participants across the U.S., Australia, Brazil, India, Israel, Italy, Mexico and the United Kingdom to receive Mounjaro (up to 5 mg or 10 mg once weekly) or placebo once weekly. The primary objective of the study was to demonstrate that Mounjaro (pooled doses) is superior to placebo in mean change in A1C from baseline after 30 weeks.

In the open-label extension of the trial (week 31 to 52), all participants received Mounjaro. Inclusion criteria for the trial included an A1C of >6.5% to ≤11% at screening, body weight ≥50 kg (110 lbs) and BMI >85th percentile of the general age and gender-matched population for that country or region. Participants in the trial had an average baseline A1C of 8.04%, an average baseline BMI of 35.4 kg/m², an average baseline weight of 96.6 kg, an average baseline BMI standard deviation score of 3.11 and a duration of diabetes of 2.4 years.

Endnotes and References

1. The efficacy estimand represents efficacy had all randomized participants remained on study intervention for 30 weeks without initiation of rescue antihyperglycemic medications (>2 weeks of use).
2. The treatment-regimen estimand represents the estimated average treatment effect on all randomized participants regardless of discontinuation of study intervention or initiation of rescue antihyperglycemic medications.

INDICATION AND SAFETY SUMMARY WITH WARNINGS
Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).

• It is not known if Mounjaro is safe and effective for use in children.

Warnings – Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.

Mounjaro may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.

Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures.

Common side effects

The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Mounjaro

• Your healthcare provider should show you how to use Mounjaro before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take other diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take

• Read the Instructions for Use that come with Mounjaro.
• Use Mounjaro exactly as your healthcare provider says.
• Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously).
• Use Mounjaro 1 time each week, at any time of the day.
• Do not mix insulin and Mounjaro together in the same injection.
• You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much Mounjaro, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Learn more

Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) [or go to www.mounjaro.lilly.com].

This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.

TR CON CBS 13JUN2025

Mounjaro^® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound (ZEHP-bownd) is an injectable prescription medicine that may help adults with:

• obesity, or some adults with overweight who also have weight-related medical problems to lose excess body weight and keep the weight off.
• moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

It should be used with a reduced-calorie diet and increased physical activity.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings – Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

• Your healthcare provider should show you how to use Zepbound before you use it for the first time.
• Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

• Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and
  

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