NCT06672549From ClinicalTrials.govRecruiting

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

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

Obesity
Overweight

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Eli Lilly and Company
Enrolment target: 125
Started: 18 November 2024
Main results due: February 2027
Study sites: 118
Registry updated: 24 September 2026

Can you take part?

Ages 6 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(118)

University of Arizona
Tucson, Arizona, United States
Not yet recruiting
Loma Linda University School of Medicine
Loma Linda, California, United States
Not yet recruiting
Childrens Hospital of Los Angeles
Los Angeles, California, United States
Not yet recruiting
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Not yet recruiting
Children's Hospital of Orange County - Orange
Orange, California, United States
Not yet recruiting
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California, United States
Not yet recruiting
Children's Hospital Colorado
Colorado Springs, Colorado, United States
Not yet recruiting
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States
Not yet recruiting
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Not yet recruiting
William A. Shands Hospital at the University of Florida
Gainesville, Florida, United States
Not yet recruiting
Florida Hospital- Center for Pediatric Research
Orlando, Florida, United States
Not yet recruiting
Nemours Children's Health
Orlando, Florida, United States
Not yet recruiting
All Childrens Hospital
St. Petersburg, Florida, United States
Not yet recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Not yet recruiting
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Not yet recruiting
University of Illinois at Chicago
Chicago, Illinois, United States
Not yet recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Not yet recruiting
Norton Children's Endocrinology
Louisville, Kentucky, United States
Not yet recruiting
Velocity Clinical Research
Lafayette, Louisiana, United States
Not yet recruiting
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, United States
Not yet recruiting
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan, United States
Not yet recruiting
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Not yet recruiting
Mayo Clinic - PIN
Rochester, Minnesota, United States
Not yet recruiting
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
Saint Paul, Minnesota, United States
Not yet recruiting
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, United States
Not yet recruiting
Sundance Clinical Research
St Louis, Missouri, United States
Not yet recruiting
Omaha Childrens Hospital
Omaha, Nebraska, United States
Not yet recruiting
Velocity Clinical Research
Omaha, Nebraska, United States
Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Not yet recruiting
UBMD Pediatrics
Buffalo, New York, United States
Not yet recruiting
UNC Children's Hospital
Chapel Hill, North Carolina, United States
Not yet recruiting
Duke Children's Primary Care
Durham, North Carolina, United States
Not yet recruiting
Lucas Research, Inc
Morehead City, North Carolina, United States
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States
Not yet recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Not yet recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Not yet recruiting
Coastal Pediatric Associates
Charleston, South Carolina, United States
Not yet recruiting
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, United States
Not yet recruiting
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
Not yet recruiting
Dell Children's Medical Center - PIN
Austin, Texas, United States
Not yet recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Not yet recruiting
McGovern Medical School
Houston, Texas, United States
Not yet recruiting
Texas Childrens Hospital
Houston, Texas, United States
Not yet recruiting
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, United States
Not yet recruiting
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, United States
Not yet recruiting
Martin Diagnostic Clinic
Tomball, Texas, United States
Not yet recruiting
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Not yet recruiting
VCU Health - Center for Endocrinology Diabetes and Metabolism
Richmond, Virginia, United States
Not yet recruiting
Seattle Children's Research Institute - Hughes Building - PIN
Seattle, Washington, United States
Not yet recruiting
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, United States
Not yet recruiting
UZ Brussel
Brussels, Belgium
Not yet recruiting
Cliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
Not yet recruiting
UZ Leuven
Leuven, Belgium
Not yet recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil
Not yet recruiting
Hospital Universitario de Caxias do Sul
Caxias do Sul, Brazil
Not yet recruiting
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, Brazil
Not yet recruiting
National Cheng Kung University Hospital
Tainan, China
Not yet recruiting
National Taiwan University Hospital
Taipei, China
Not yet recruiting

Showing 60 of 118 sites — filter to narrow it down. 1 of the 118 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06672549. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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