RECRUITING

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

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 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.

Official Title

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)

Quick Facts

Study Start:2024-06-03
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06439277

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 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.
  2. * Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
  3. * Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
  1. * Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to
  2. * gastric bypass
  3. * sleeve gastrectomy
  4. * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  5. * any other procedure intended to result in weight reduction.
  6. * 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
  7. * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
  8. * Have type 2 diabetes or have a HbA1c \> 6.4% at screening
  9. * Have a history of chronic or acute pancreatitis
  10. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

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)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, 95821
United States
Nemours Children's Health - Delaware
Wilmington, Delaware, 19803
United States
CenExel iResearch, LLC
Decatur, Georgia, 30030
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
UBMD Pediatrics
Buffalo, New York, 14203
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
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 Date2024-06-03
Study Completion Date2030-12

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2030-12

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Weight Gain