A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Recruiting · NCT06672549 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
OrforglipronPlacebo
What this trial is about
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.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 29 US states.
- University of Arizona - Tucson, Arizona, United States
- Loma Linda University School of Medicine - Loma Linda, California, United States
- Childrens Hospital of Los Angeles - Los Angeles, California, United States
- UCLA Mattel Children's Hospital - Los Angeles, California, United States
- Children's Hospital of Orange County - Orange - Orange, California, United States
- Carey Chronis MD Pediatric, Infant and Adolescent Medicine - Oxnard, California, United States
- Children's Hospital Colorado - Colorado Springs, Colorado, United States
- Yale School of Medicine - Yale Diabetes Center (YDC)) Trials - New Haven, Connecticut, United States
- Stamford Therapeutics Consortium - Stamford, Connecticut, United States
- William A. Shands Hospital at the University of Florida - Gainesville, Florida, United States
- Florida Hospital- Center for Pediatric Research - Orlando, Florida, United States
- Nemours Children's Health - Orlando, Florida, United States
- All Childrens Hospital - St. Petersburg, Florida, United States
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics - Atlanta, Georgia, United States
- Ann and Robert Lurie Children's Hospital of Chicago - Chicago, Illinois, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- Norton Children's Endocrinology - Louisville, Kentucky, United States
- Velocity Clinical Research - Lafayette, Louisiana, United States
- Johns Hopkins Children's Center - Baltimore, Maryland, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- Helen Devos Childrens' Hospital - PIN - Grand Rapids, Michigan, United States
- University of Minnesota Masonic Children's Hospital - Minneapolis, Minnesota, United States
- Mayo Clinic - PIN - Rochester, Minnesota, United States
- Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center - Saint Paul, Minnesota, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical Research - Gulfport, Mississippi, United States
- Sundance Clinical Research - St Louis, Missouri, United States
- Omaha Childrens Hospital - Omaha, Nebraska, United States
- Velocity Clinical Research - Omaha, Nebraska, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- UBMD Pediatrics - Buffalo, New York, United States
- UNC Children's Hospital - Chapel Hill, North Carolina, United States
- Duke Children's Primary Care - Durham, North Carolina, United States
- Lucas Research, Inc - Morehead City, North Carolina, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Nationwide Children's Hospital - Columbus, Ohio, United States
- University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- UPMC Children's Hospital of Pittsburgh - Pittsburgh, Pennsylvania, United States
- Coastal Pediatric Associates - Charleston, South Carolina, United States
- Medical University of South Carolina Children Hospital - PIN - Charleston, South Carolina, United States
- Vanderbilt Health One Hundred Oaks - Nashville, Tennessee, United States
- Dell Children's Medical Center - PIN - Austin, Texas, United States
- Driscoll Children's Hospital - Corpus Christi, Texas, United States
- McGovern Medical School - Houston, Texas, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical Research - Houston, Texas, United States
- La Providence Pediatrics Clinic - Chemidox Clinical Trials - Houston, Texas, United States
- Martin Diagnostic Clinic - Tomball, Texas, United States
- Velocity Clinical Research, Salt Lake City - West Jordan, Utah, United States
- VCU Health - Center for Endocrinology Diabetes and Metabolism - Richmond, Virginia, United States
- Seattle Children's Research Institute - Hughes Building - PIN - Seattle, Washington, United States
- MultiCare Health System - Mary Bridge Children's Health Center - Tacoma, Washington, United States
- Hospital Universitario Vall d'Hebron - Barcelona, Spain
- Barnsley Hospital NHS Foundation Trust - Barnsley, United Kingdom
- Yitzhak Shamir Medical Center - Beer Yaacov, Israel
- L2IP - Instituto de Pesquisas Clínicas - Brasília, Brazil
- Bristol Royal Hospital for Children - Bristol, United Kingdom
- UZ Brussel - Brussels, Belgium
- Cliniques Universitaires Saint-Luc - PPDS - Brussels, Belgium
- Addenbrookes Hospital - Cambridge, United Kingdom
- Hospital Universitario de Caxias do Sul - Caxias do Sul, Brazil
Showing 60 of 117 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →