A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

What this study is about

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. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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).

🚫 You may not be able to join if…

• 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 this trial is running

• Children's Hospital Los Angeles, Los Angeles, California, United States
• Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology, Sacramento, California, United States
• Nemours Children's Health - Delaware, Wilmington, Delaware, United States
• Medical Research Partners, Ammon, Idaho, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
• Indiana University Health University Hospital, Indianapolis, Indiana, United States
• UBMD Pediatrics, Buffalo, New York, United States
• SUNY Upstate Medical University, Syracuse, New York, United States
• Driscoll Children's Hospital, Corpus Christi, Texas, United States
• Epic Medical Research - DeSoto, DeSoto, Texas, United States
• Valley Institute of Research - Fort Worth, Fort Worth, Texas, United States
• Consano Clinical Research, LLC, Shavano Park, Texas, United States

+ 60 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06439277.