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
Eli Lilly and Company
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.
Description
The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- 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…
Interventions
- DrugOrforglipron
Administered orally. ISA specific interventions will be listed in the ISA.
- DrugPlacebo
Administered orally. ISA specific interventions will be listed in the ISA.
Locations (50)
- Carey Chronis MD Pediatric, Infant and Adolescent MedicineVentura, California
- Yale School of Medicine - Yale Diabetes Center (YDC)) TrialsNew Haven, Connecticut
- Stamford Therapeutics ConsortiumStamford, Connecticut
- Children's Healthcare of Atlanta - Center for Advanced PediatricsAtlanta, Georgia
- Ann and Robert Lurie Children's Hospital of ChicagoChicago, Illinois
- Velocity Clinical ResearchLafayette, Louisiana