A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Description

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.

Conditions

Obesity, Overweight

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Study Overview

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Study Details

Study overview

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Decatur

CenExel iResearch, LLC, Decatur, Georgia, United States, 30030

Meridian

Solaris Clinical Research, Meridian, Idaho, United States, 83646

Topeka

Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, United States, 66606

Baton Rouge

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States, 70808

Baltimore

Barry J. Reiner, MD, LLC, Baltimore, Maryland, United States, 21229

Minneapolis

M Health Fairview - Delaware Clinical Research Unit (DCRU), Minneapolis, Minnesota, United States, 55414

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Columbus

Aventiv Research Inc, Columbus, Ohio, United States, 43213

Dayton

PriMED Clinical Research, Dayton, Ohio, United States, 45429

Nashville

Vanderbilt Health One Hundred Oaks, Nashville, Tennessee, United States, 372212

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 obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
  • * Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
  • * dyslipidemia
  • * pre-hypertension
  • * hypertension
  • * nonalcoholic fatty liver disease
  • * obstructive sleep apnea
  • * prediabetes
  • * documented preexisting condition of Type 2 Diabetes
  • * Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%
  • * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
  • * Have Type 1 Diabetes
  • * Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
  • * Are prepubertal (Tanner stage 1).
  • * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
  • * Have a history of chronic or acute pancreatitis.
  • * Have undergone or plan to undergo 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.

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

2026-10-01