Tirzepatide for Obesity

Not currently recruiting at 51 trial locations

Overseen By Kimball Johnson, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Metformin

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Prepubertal, 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: 25

Duration: 72 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of tirzepatide, a medication for weight management, in teens with obesity or who are overweight with an additional weight-related health issue, such as high blood pressure or sleep apnea. Participants will receive either tirzepatide or a placebo over approximately 90 weeks, with up to 25 visits. Eligible teens have a high BMI (a measure of body fat based on height and weight) and at least one weight-related health condition. The trial aims to determine if tirzepatide can help manage weight and related health issues in these adolescents. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new weight management treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking any medications or supplements for weight loss, you must stop them at least 90 days before joining the study.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally well-tolerated and can aid in weight loss. Some patients have experienced stomach-related side effects, such as nausea, diarrhea, and vomiting, which are the most common and usually mild. Serious issues can occur but are rare.

One study compared tirzepatide to another weight-loss drug and found better results in reducing body weight. This suggests tirzepatide's effectiveness, but side effects should be considered. As this study is in a later phase, there is already some evidence of safety in humans. However, individual experiences can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Tirzepatide is unique because it combines the actions of two hormones, GLP-1 and GIP, which play a role in regulating appetite and glucose levels. Unlike current obesity treatments that typically focus on just one of these pathways, tirzepatide targets both, potentially leading to more effective weight loss. Researchers are particularly excited because this dual-action approach could offer enhanced benefits in reducing body weight and improving metabolic health compared to existing options.

What evidence suggests that tirzepatide might be an effective treatment for obesity?

Research has shown that tirzepatide, which participants in this trial may receive, can aid in weight loss. One study found that individuals taking tirzepatide lost more weight than those using another weight-loss drug, semaglutide. Another study demonstrated that tirzepatide helped adults with obesity lose weight and reduce waist size. Additionally, tirzepatide has been associated with a lower risk of major health problems, such as heart and kidney issues. These positive findings suggest that tirzepatide might also be effective for managing obesity in teenagers. ^{1 3 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

This trial is for adolescents with obesity (BMI ≥95th percentile) or overweight with weight-related issues like high cholesterol, high blood pressure, liver disease, sleep apnea, or prediabetes. Those treated for Type 2 Diabetes with diet/exercise or metformin can join if their HbA1c is below 9.0%.

Inclusion Criteria

I am overweight according to BMI charts for my age and sex, and I have a weight-related health issue.

I have Type 2 Diabetes, treated with diet, exercise, or metformin, and my HbA1c is below 9.0%.

My BMI is in the top 5% for my age and sex.

Exclusion Criteria

You have Type 1 Diabetes.

I have a history of pancreatitis.

I have used or plan to use weight loss products within the last 90 days.

Timeline for a Trial Participant

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 25 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study tests the safety and effectiveness of Tirzepatide, a medication given once weekly to help manage obesity in teens. It's compared against a placebo over about 90 weeks and includes up to 25 visits to check progress.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

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

Published Research Related to This Trial

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]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, has a safety profile similar to other GLP-1 receptor agonists, but higher doses (10mg and above) are associated with increased risks of hypoglycemia and treatment discontinuation.

In clinical trials involving 9818 patients, higher doses of tirzepatide led to more frequent gastrointestinal side effects like nausea, vomiting, and diarrhea, indicating that these adverse events are dose-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? Meng, Z., Yang, M., Wen, H., et al.[2023]

Tirzepatide, a new medication approved by the FDA, acts as an agonist for both GLP-1 and GIP receptors, which helps improve blood sugar control in patients with type II diabetes when combined with diet and exercise.

This drug represents a significant advancement in diabetes management, offering a new approach to treatment by targeting multiple pathways involved in glucose regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. Al-Horani, RA., Chedid, M.[2023]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

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 significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., 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, 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, 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]

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, 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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Treatment with tirzepatide was superior to treatment with semaglutide with respect to reduction in body weight and waist circumference at week 72.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40746703/

Weight Loss Efficacy of Tirzepatide Compared to Placebo ... We included studies involving adult participants who were overweight or obese despite T2DM or OHA use, with a trial duration of at least 20 weeks. The primary ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822209

Clinical Outcomes of Tirzepatide or GLP-1 Receptor ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity The present trial, SURMOUNT-1, evaluated the efficacy and safety of tirzepatide in adults with obesity or overweight who did not have diabetes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964993/

Real‐world use and effectiveness of tirzepatide among ... To understand real‐world tirzepatide utilization and effectiveness (change in weight and body mass index [BMI]) among people without type 2 diabetes (T2D) in ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf This medication also demonstrates efficacy in weight loss, leading to its off-label use for obesity treatment. Tirzepatide is a dual agonist for the glucagon- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05822830

A Study of Tirzepatide (LY3298176) in Participants With ... The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks GLP-1RAs are effective in managing obesity, their use is associated with gastrointestinal side effects and rare but serious adverse events.