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A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
RecruitingPhase 3
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
Who can join
Ages 6 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria:
* 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.
* 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
* 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,
* hypertension
* type 2 diabetes (T2D)
* prediabetes
* dyslipidemia
* obstructive sleep apnea
* metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)
Exclusion Criteria:
* 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.
* 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.
* 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 HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening.
* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
About the study
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.
What is being tested
- Orforglipron (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 125 · Started: Nov 18, 2024
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT06672549
Locations in the U.S.
| Arizona | University of Arizona, Tucson (Not yet recruiting) |
| California | Loma Linda University School of Medicine, Loma Linda (Not yet recruiting) Childrens Hospital of Los Angeles, Los Angeles (Not yet recruiting) UCLA Mattel Children's Hospital, Los Angeles (Not yet recruiting) Children's Hospital of Orange County - Orange, Orange (Not yet recruiting) Carey Chronis MD Pediatric, Infant and Adolescent Medicine, Oxnard (Not yet recruiting) |
| Colorado | Children's Hospital Colorado, Colorado Springs (Not yet recruiting) |
| Connecticut | Yale School of Medicine - Yale Diabetes Center (YDC)) Trials, New Haven (Not yet recruiting) Stamford Therapeutics Consortium, Stamford (Not yet recruiting) |
| Florida | William A. Shands Hospital at the University of Florida, Gainesville (Not yet recruiting) Florida Hospital- Center for Pediatric Research, Orlando (Not yet recruiting) Nemours Children's Health, Orlando (Not yet recruiting) All Childrens Hospital, St. Petersburg (Not yet recruiting) |
| Georgia | Children's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta (Not yet recruiting) |
| Illinois | Ann and Robert Lurie Children's Hospital of Chicago, Chicago (Not yet recruiting) University of Illinois at Chicago, Chicago (Not yet recruiting) |
| Indiana | Riley Hospital for Children, Indianapolis (Not yet recruiting) |
| Kentucky | Norton Children's Endocrinology, Louisville (Not yet recruiting) |
| Louisiana | Velocity Clinical Research, Lafayette (Not yet recruiting) |
| Maryland | Johns Hopkins Children's Center, Baltimore (Not yet recruiting) |
| Massachusetts | Boston Children's Hospital, Boston (Not yet recruiting) |
| Michigan | Helen Devos Childrens' Hospital - PIN, Grand Rapids (Not yet recruiting) |
| Minnesota | University of Minnesota Masonic Children's Hospital, Minneapolis (Not yet recruiting) Mayo Clinic - PIN, Rochester (Not yet recruiting) Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center, Saint Paul (Not yet recruiting) |
| Mississippi | Dynamed Clinical Research, LP d/b/a DM Clinical Research, Gulfport (Not yet recruiting) |
| Missouri | Sundance Clinical Research, St Louis (Not yet recruiting) |
| Nebraska | Omaha Childrens Hospital, Omaha (Not yet recruiting) Velocity Clinical Research, Omaha (Not yet recruiting) |
| New Jersey | Hackensack University Medical Center, Hackensack (Not yet recruiting) |
| New York | UBMD Pediatrics, Buffalo (Not yet recruiting) |
| North Carolina | UNC Children's Hospital, Chapel Hill (Not yet recruiting) Duke Children's Primary Care, Durham (Not yet recruiting) Lucas Research, Inc, Morehead City |
| Ohio | Cleveland Clinic, Cleveland (Not yet recruiting) Nationwide Children's Hospital, Columbus (Not yet recruiting) |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City (Not yet recruiting) |
| Pennsylvania | UPMC Children's Hospital of Pittsburgh, Pittsburgh (Not yet recruiting) |
| South Carolina | Coastal Pediatric Associates, Charleston (Not yet recruiting) Medical University of South Carolina Children Hospital - PIN, Charleston (Not yet recruiting) |
| Tennessee | Vanderbilt Health One Hundred Oaks, Nashville (Not yet recruiting) |
| Texas | Dell Children's Medical Center - PIN, Austin (Not yet recruiting) Driscoll Children's Hospital, Corpus Christi (Not yet recruiting) Dynamed Clinical Research, LP d/b/a DM Clinical Research, Houston (Not yet recruiting) La Providence Pediatrics Clinic - Chemidox Clinical Trials, Houston (Not yet recruiting) McGovern Medical School, Houston (Not yet recruiting) Texas Childrens Hospital, Houston (Not yet recruiting) Martin Diagnostic Clinic, Tomball (Not yet recruiting) |
| Utah | Velocity Clinical Research, Salt Lake City, West Jordan (Not yet recruiting) |
| Virginia | VCU Health - Center for Endocrinology Diabetes and Metabolism, Richmond (Not yet recruiting) |
| Washington | Seattle Children's Research Institute - Hughes Building - PIN, Seattle (Not yet recruiting) MultiCare Health System - Mary Bridge Children's Health Center, Tacoma (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.