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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT06672549

Run by

Eli Lilly and Company

People needed

125

Starts

2024-11-18

Expected to finish

2027-03-01

Last updated by the study team

2026-07-20

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

• Lucas Research, Inc — Morehead City, North Carolina, United States (enrolling)
• Childrens Hospital of Los Angeles — Los Angeles, California, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Children's Hospital of Orange County - Orange — Orange, California, United States
• Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Ventura, 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
• UCLA Mattel Children's Hospital — Los Angeles, California, 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
• Loma Linda University School of Medicine — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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