ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. Participants who have completed the primary 72-week GPHP 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.

Official Title

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)

Quick Facts

Study Start:2023-10-16
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06075667

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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.
  3. * dyslipidemia
  4. * pre-hypertension
  5. * hypertension
  6. * nonalcoholic fatty liver disease
  7. * obstructive sleep apnea
  8. * prediabetes
  9. * documented preexisting condition of Type 2 Diabetes
  10. * 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%
  1. * 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.
  2. * Have Type 1 Diabetes
  3. * 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.
  4. * Are prepubertal (Tanner stage 1).
  5. * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
  6. * Have a history of chronic or acute pancreatitis.
  7. * Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to
  8. * gastric bypass
  9. * sleeve gastrectomy
  10. * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  11. * any other procedure intended to result in weight reduction.

Contacts and Locations

Principal Investigator

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 Locations (Sites)

CenExel iResearch, LLC
Decatur, Georgia, 30030
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229
United States
M Health Fairview - Delaware Clinical Research Unit (DCRU)
Minneapolis, Minnesota, 55414
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Aventiv Research Inc
Columbus, Ohio, 43213
United States
PriMED Clinical Research
Dayton, Ohio, 45429
United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 372212
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16
Study Completion Date2029-07

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight