Tirzepatide for Adolescent Obesity

Recruiting at 86 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Pancreatitis, Medullary thyroid carcinoma, 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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 72 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Tirzepatide for adolescent obesity?

Research shows that Tirzepatide, a drug used for type 2 diabetes, also helps with weight loss. In studies, people using Tirzepatide lost a significant amount of weight, which suggests it could be effective for managing obesity. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been studied in people with type 2 diabetes and is generally safe, with common side effects like mild to moderate nausea, vomiting, diarrhea, and constipation. It has shown no increased risk of serious heart-related events compared to other treatments. ^{1 2 6 7 8}

What makes the drug Tirzepatide unique for treating adolescent obesity?

Tirzepatide is unique because it combines two hormone actions, GIP and GLP-1, to help control blood sugar and reduce appetite, which may lead to weight loss. This dual action is different from other treatments that typically target only one hormone pathway. ^{9 10 11 12 13}

What is the purpose of this trial?

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

Research Team

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

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adolescents with obesity and weight-related health issues. Participants should be committed to a healthy diet and exercise routine. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve age range, BMI thresholds, and absence of conditions that could interfere with the study.

Inclusion Criteria

Have history of at least 1 self-reported unsuccessful dietary effort to lose weight

My BMI is in the top 5% for my age and sex, and I have at least two conditions like high blood pressure, prediabetes, or high triglycerides.

I can sign the consent form myself or have someone legally authorized to do so.

Exclusion Criteria

I plan to or have had surgery to help me lose weight.

I or my family have a history of medullary thyroid cancer or MEN2.

I have lost more than 5 kg in weight in the last 3 months without trying.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or placebo subcutaneously once weekly

72 weeks

Up to 23 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study tests Tirzepatide's effectiveness in reducing body weight and improving heart health risks compared to a placebo. It spans roughly 76 weeks with up to 23 check-ins, where participants will also follow prescribed nutrition and physical activity plans.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC.

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

• Type 2 diabetes

Approved in European Union as Mounjaro for:

• Type 2 diabetes

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Approved in United States as Zepbound for:

• Weight loss
• Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

• Weight loss

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

Findings from Research

Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.

The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

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]

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]

Tirzepatide, a dual GLP-1/GIP receptor co-agonist, has been shown to significantly reduce glycosylated hemoglobin levels (1.87% to 3.02%) and body weight (5.4 to 12.9 kg) in people with type 2 diabetes over treatment periods of up to 104 weeks, demonstrating its efficacy compared to placebo and other diabetes medications.

In individuals without diabetes, tirzepatide also led to substantial weight loss (16.5% to 22.4%) over 72 weeks, indicating its potential for obesity management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. Sinha, R., Papamargaritis, D., Sargeant, JA., et al.[2023]

Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[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, a novel GLP-1 receptor agonist, has been shown to significantly reduce A1C levels and body weight in patients with type 2 diabetes compared to placebo and other active treatments.

The safety profile of tirzepatide is similar to other GLP-1 receptor agonists, with the most common side effects being mild to moderate gastrointestinal issues, and it does not increase the risk of hypoglycemia, making it a promising treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. Kushner, P., Anderson, JE., Simon, J., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed significant reductions in Hemoglobin A1c levels (up to 3.02%) and weight loss in adults with uncontrolled type 2 diabetes, outperforming both placebo and active comparators like semaglutide.

The safety profile of tirzepatide was comparable to semaglutide regarding gastrointestinal adverse effects, and it did not increase the incidence of major cardiovascular events compared to insulin glargine, indicating it may be a valuable addition to diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]

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]

Gepants, a new class of migraine treatments including ubrogepant, atogepant, rimegepant, and zavegepant, have been shown to be effective and safe for both acute and preventive therapy of migraines, with various administration routes (oral and intranasal).

Current literature suggests that while gepants are well-tolerated and effective, it is still unclear if they will outperform existing migraine treatments like triptans and monoclonal antibodies in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacotherapeutic management of episodic and chronic migraine with gepants. Tajti, J., Szok, D., Csáti, A., 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]

Zavegepant, a newly approved intranasal gepant, represents a significant advancement in migraine treatment by antagonizing the CGRP receptor, which is linked to chronic migraine conditions.

Unlike earlier gepants, zavegepant and other recent oral gepants like rimegepant and ubrogepant have been approved without warnings for hepatotoxicity, suggesting a potentially safer profile, although long-term safety and efficacy data are still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus on zavegepant: the first intranasal third-generation gepant. Scuteri, D., Tarsitano, A., Tonin, P., et al.[2022]

CGRP-targeted monoclonal antibodies and small-molecule antagonists (gepants) are FDA-approved treatments for migraine, which affects about 16% of the US population, highlighting their importance in managing this common neurological disorder.

Clinical studies, including randomized controlled trials, have demonstrated the efficacy and tolerability of these CGRP-targeted therapies, confirming their role in interrupting the neurogenic inflammation associated with migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale. Cohen, F., Yuan, H., Silberstein, SD.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Adverse Events Related to Tirzepatide. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. [2022]

6. 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]

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

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]

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

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

The pharmacotherapeutic management of episodic and chronic migraine with gepants. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Focus on zavegepant: the first intranasal third-generation gepant. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale. [2023]