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

Description

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.

Conditions

Obesity, Weight Gain

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Study Overview

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Study Details

Study overview

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.

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Sacramento

Center Of Excellence in Diabetes and Endocrinology, Sacramento, California, United States, 95821

Wilmington

Nemours Children's Health - Delaware, Wilmington, Delaware, United States, 19803

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Indianapolis

Indiana University Health University Hospital, Indianapolis, Indiana, United States, 46202

Buffalo

UBMD Pediatrics, Buffalo, New York, United States, 14203

Syracuse

SUNY Upstate Medical University, Syracuse, New York, United States, 13210

Corpus Christi

Driscoll Children's Hospital, Corpus Christi, Texas, United States, 78411

Shavano Park

Consano Clinical Research, LLC, Shavano Park, Texas, United States, 78231

Weslaco

Texas Valley Clinical Research, Weslaco, Texas, United States, 78596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-06