🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06672549
Recruiting Phase 3

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

NCT06672549 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-11-18
Last updated
2026-08-24

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

OrforglipronPlacebo

Orforglipron: Administered orally. ISA specific interventions will be listed in the ISA.

Placebo: Administered orally. ISA specific interventions will be listed in the ISA.

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (117)

FacilityCityRegionStatus
University of Arizona Tucson Arizona Not Yet Recruiting
Loma Linda University School of Medicine Loma Linda California Not Yet Recruiting
Childrens Hospital of Los Angeles Los Angeles California Not Yet Recruiting
UCLA Mattel Children's Hospital Los Angeles California Not Yet Recruiting
Children's Hospital of Orange County - Orange Orange California Not Yet Recruiting
Carey Chronis MD Pediatric, Infant and Adolescent Medicine Oxnard California Not Yet Recruiting
Children's Hospital Colorado Colorado Springs Colorado Not Yet Recruiting
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials New Haven Connecticut Not Yet Recruiting
Stamford Therapeutics Consortium Stamford Connecticut Not Yet Recruiting
William A. Shands Hospital at the University of Florida Gainesville Florida Not Yet Recruiting
Florida Hospital- Center for Pediatric Research Orlando Florida Not Yet Recruiting
Nemours Children's Health Orlando Florida Not Yet Recruiting
All Childrens Hospital St. Petersburg Florida Not Yet Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia Not Yet Recruiting
Ann and Robert Lurie Children's Hospital of Chicago Chicago Illinois Not Yet Recruiting
University of Illinois at Chicago Chicago Illinois Not Yet Recruiting
Riley Hospital for Children Indianapolis Indiana Not Yet Recruiting
Norton Children's Endocrinology Louisville Kentucky Not Yet Recruiting
Velocity Clinical Research Lafayette Louisiana Not Yet Recruiting
Johns Hopkins Children's Center Baltimore Maryland Not Yet Recruiting
Boston Children's Hospital Boston Massachusetts Not Yet Recruiting
Helen Devos Childrens' Hospital - PIN Grand Rapids Michigan Not Yet Recruiting
University of Minnesota Masonic Children's Hospital Minneapolis Minnesota Not Yet Recruiting
Mayo Clinic - PIN Rochester Minnesota Not Yet Recruiting
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center Saint Paul Minnesota Not Yet Recruiting
Dynamed Clinical Research, LP d/b/a DM Clinical Research Gulfport Mississippi Not Yet Recruiting
Sundance Clinical Research St Louis Missouri Not Yet Recruiting
Omaha Childrens Hospital Omaha Nebraska Not Yet Recruiting
Velocity Clinical Research Omaha Nebraska Not Yet Recruiting
Hackensack University Medical Center Hackensack New Jersey Not Yet Recruiting
UBMD Pediatrics Buffalo New York Not Yet Recruiting
UNC Children's Hospital Chapel Hill North Carolina Not Yet Recruiting
Duke Children's Primary Care Durham North Carolina Not Yet Recruiting
Lucas Research, Inc Morehead City North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Nationwide Children's Hospital Columbus Ohio Not Yet Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Not Yet Recruiting
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania Not Yet Recruiting
Coastal Pediatric Associates Charleston South Carolina Not Yet Recruiting
Medical University of South Carolina Children Hospital - PIN Charleston South Carolina Not Yet Recruiting

+ 77 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672549 on ClinicalTrials.gov ↗ ← All trials in the UK