The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
125
Administered orally
Administered orally
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Change from Baseline in BMI
Time frame: Baseline, Week 72
Change from Baseline in Body Weight
Time frame: Baseline, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 72
Change from Baseline in Body Weight Percentile
Based on sex- and age-specific growth charts
Time frame: Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores
The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains: * physical comfort (6 items) * body esteem (9 items) * social life (6 items), and * family relations (6 items). It has a recall period of "the past 7 days." All items are rated on a 5-point truth scale ("always true" to "never true"). The 4-domain scores and total score range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, United States
RECRUITINGYale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States
NOT_YET_RECRUITINGStamford Therapeutics Consortium
Stamford, Connecticut, United States
RECRUITINGChildren's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGVelocity Clinical Research
Lafayette, Louisiana, United States
RECRUITINGMedPharmics, LLC
Gulfport, Mississippi, United States
RECRUITINGSundance Clinical Research
St Louis, Missouri, United States
RECRUITINGLucas Research, Inc.
Morehead City, North Carolina, United States
RECRUITINGChildrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITING...and 27 more locations
Time frame: Baseline, Week 72
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 72
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron
Time frame: Baseline, Week 72