Obesity, Overweight
Conditions
Brief 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.
Detailed 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.
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.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
The PWMP protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Eligibility
Sex/Gender
ALL
Age
6 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Allocated to Each ISA | Baseline to Week 72 |
Countries
Belgium, Brazil, China, Israel, Italy, Japan, Mexico, Poland, Portugal, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed