RECRUITING

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

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Conditions

ObesityOverweight

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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 purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Official Title

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

Quick Facts

Study Start:2024-11-18
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06672549

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:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
  2. * Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR
  3. * Applies to participant age between 12 and \<18 years old. 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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
  4. * hypertension
  5. * type 2 diabetes (T2D)
  6. * prediabetes
  7. * dyslipidemia
  8. * obstructive sleep apnea
  9. * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)
  1. * Have undergone or plan to undergo 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 diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
  7. * 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
  8. * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
  9. * Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening.
  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)

Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, 93003-5369
United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, 06519
United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Velocity Clinical Research
Lafayette, Louisiana, 70508
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, 39503-2637
United States
Sundance Clinical Research
Saint Louis, Missouri, 63141-7068
United States
Velocity Clinical Research
Omaha, Nebraska, 68134
United States
Lucas Research, Inc
Morehead City, North Carolina, 28557
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, 77065
United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, 77071-1008
United States
Martin Diagnostic Clinic
Tomball, Texas, 77375-3332
United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
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 Date2024-11-18
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-11-18
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight