Tirzepatide for Pediatric Type 2 Diabetes

(SURPASS-PEDS Trial)

Recruiting at 79 trial locations

Overseen By Steven Willi, MD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Metformin, Basal insulin

Must not be taking: Weight loss medications

Disqualifiers: Type 1 diabetes, Pancreatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 30 weeks

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing tirzepatide, a medication that helps control blood sugar levels, in children and teenagers with type 2 diabetes. These participants are already taking other diabetes medications like metformin or basal insulin. Tirzepatide works by helping the body use insulin more effectively and reducing sugar production in the liver. Tirzepatide is a new medication being tested for its effectiveness and safety in people with type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your metformin and/or basal insulin dose is stable for at least 90 days before joining the study.

Is tirzepatide safe for humans?

Tirzepatide has been tested in several clinical trials for type 2 diabetes and is generally considered safe, with common side effects including nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has also shown cardiovascular safety, with no increased risk of major cardiovascular events compared to other treatments. ^{1 2 3 4 5}

What makes the drug Tirzepatide unique for treating pediatric type 2 diabetes?

Tirzepatide is unique because it combines two types of hormone actions, GIP and GLP-1, which help control blood sugar levels, making it different from other diabetes treatments that typically target only one hormone pathway. ^{6 7 8 9 10}

What data supports the effectiveness of the drug Tirzepatide for treating type 2 diabetes?

Tirzepatide has shown remarkable effectiveness in lowering blood sugar levels and promoting weight loss in adults with type 2 diabetes, with many patients achieving normal blood sugar levels. It has been more effective than other treatments like semaglutide and basal insulin in reducing blood sugar and body weight. ^{1 2 5 11 12}

Who Is on the Research Team?

1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 10 to under 18 with type 2 diabetes, who are already taking metformin or basal insulin. They should have a stable dose for at least 90 days prior to screening, an HbA1c level over 6.5% but not above 11%, weigh at least 50 kg (110 pounds), and have a BMI above the 85th percentile for their age and gender.

Inclusion Criteria

I manage my type 2 diabetes with diet, exercise, and stable doses of metformin or insulin.

I weigh at least 110 pounds and my BMI is in the top 15% for my age and gender.

I am between 10 and 17 years old.

Exclusion Criteria

I have had pancreatitis before.

I am not pregnant, breastfeeding, or planning to become pregnant.

I have had diabetic ketoacidosis or hyperosmolar syndrome after being diagnosed with type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Tirzepatide or placebo by weekly SC injection, with dose adjustments every four weeks

30 weeks

14 visits (in-person), 6 visits (phone)

Open-label extension

Participants continue to receive Tirzepatide at the last dose level

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tirzepatide

Trial Overview The study tests the safety and effectiveness of Tirzepatide in two different doses compared to a placebo in young patients with type 2 diabetes inadequately controlled by metformin or basal insulin. It involves around sixty weeks of participation, including up to fourteen clinic visits and six phone calls.

How Is the Trial Designed?

Group I: Tirzepatide Dose 2 Experimental Treatment 1 Intervention

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

Group II: Tirzepatide Dose 1 Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 2 Interventions

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 Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed greater improvements in glucose control and weight loss compared to the GLP-1 receptor agonist dulaglutide in a study involving 316 participants with type 2 diabetes.

The improvements in insulin sensitivity and beta-cell function with tirzepatide were only partially linked to weight loss, indicating that its dual receptor action provides unique mechanisms for better glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. Thomas, MK., Nikooienejad, A., Bray, R., et al.[2022]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

In a phase 3 trial involving 636 Japanese adults with type 2 diabetes, tirzepatide demonstrated superior efficacy in lowering HbA1c levels compared to dulaglutide, with reductions of -2.4% to -2.8% for tirzepatide versus -1.3% for dulaglutide after 52 weeks.

Tirzepatide also led to significant weight loss, with reductions ranging from -5.8 kg to -10.7 kg depending on the dose, while dulaglutide resulted in only a -0.5 kg reduction, indicating its potential as an effective treatment for both glycemic control and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Inagaki, N., Takeuchi, M., Oura, T., et al.[2022]

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide demonstrated a dose-dependent ability to lower HbA1c levels in adults with type 2 diabetes, with reductions ranging from -17.71 to -22.35 mmol/mol compared to placebo, and was also more effective in reducing body weight than other treatments.

While tirzepatide did not increase the risk of hypoglycaemia compared to placebo and showed lower rates than basal insulin, it was associated with a higher incidence of gastrointestinal side effects, particularly nausea and vomiting, especially at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).

Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. Mishra, R., Raj, R., Elshimy, G., et al.[2023]

CGRP antagonists, including second-generation gepants like rimegepant and ubrogepant, have been shown to be effective for both acute and preventive treatment of migraines, with no increased mortality risks associated with their use.

While serious adverse events were reported, they were likely unrelated to the medications, indicating a favorable safety profile; however, ongoing monitoring for long-term side effects, particularly in elderly populations, is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gepants for Acute and Preventive Migraine Treatment: A Narrative Review. Rissardo, JP., Caprara, ALF.[2022]

Migraine is a prevalent issue among children and adolescents, leading to significant disability, yet there are limited evidence-based treatment options compared to adults.

This review highlights the need for evaluating newer migraine therapies, such as onabotulinumtoxinA and CGRP monoclonal antibodies, in pediatric populations, as current treatments do not work for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents. VanderPluym, JH., Victorio, MCC., Oakley, CB., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Gepants for Acute and Preventive Migraine Treatment: A Narrative Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A placebo-controlled, randomized, single and multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of rimegepant in healthy participants. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis. [2023]