A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorEli Lilly and Company
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
gastric bypass
sleeve gastrectomy
restrictive bariatric surgery, such as Lap-Band® gastric banding, or
any other procedure intended to result in weight reduction.
Trial design
Design model
Single group
Treatments tested in this trial
Orforglipron
DrugAdministered orally. ISA specific interventions will be listed in the ISA.
Placebo
DrugAdministered orally. ISA specific interventions will be listed in the ISA.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Orforglipron (ISA PW01)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Allocated to Each ISA
Time frame
Baseline to Week 72Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov