Evaluating tirzepatide for treating obesity in adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effects of tirzepatide on body weight and cardiovascular risk factors in adolescents with obesity and related health issues. Participants will receive either tirzepatide or a placebo while following a program that includes healthy nutrition and physical activity. The study will last approximately 76 weeks and may involve up to 23 visits to monitor progress and safety. The primary focus is on determining the safety and efficacy of tirzepatide in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria:

* Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to

  * gastric bypass
  * sleeve gastrectomy
  * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  * any other procedure intended to result in weight reduction.
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
* Have type 2 diabetes or have a HbA1c \> 6.4% at screening
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Where it's running

• Winterberry Research Inc.
  Hamilton, Canada Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Active not recruiting
• Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
  Sacramento, California, United States Active not recruiting
• Nemours Children's Health - Delaware
  Wilmington, Delaware, United States Active not recruiting
• Medical Research Partners
  Ammon, Idaho, United States Active not recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Active not recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-intensity interval exercise to support brain activity and weight maintenance

  This trial will test whether a 12-week high-intensity interval training (HIIT) program changes brain activity and helps with weight maintenance in adults 18–70, including people who regained weight after bariatric surgery.

  Recruiting Joslin Diabetes Center · Boston, Massachusetts · NCT06511310

• Comparing two methods for weight loss after gastric bypass

  This study is testing two different ways to help people who have gained weight after gastric bypass surgery lose weight again, to see which method works better and is safer.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT06131281

• Obesity prevention program for high-risk infants

  This study is testing a parenting program to help prevent obesity in infants from low-income or minority communities during regular doctor visits.

  Recruiting Phase 2 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT06028113

• Understanding how sleep affects metabolism and weight gain

  This study is testing how not getting enough sleep and the timing of sleep can affect metabolism and weight gain in people.

  Recruiting Oregon Health and Science University · Portland, Oregon · NCT05775627

• Effects of exercise on fat tissue in obese individuals

  This study tests how exercise affects fat tissue in people with obesity to see if it can help improve their metabolism and manage weight better.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT04812314

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.