The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Administered SC
Administered SC
University of Arizona
Tucson, Arizona, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 84
Change from Baseline in Body Weight
Time frame: Baseline, Week 84
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 84
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 84
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 84
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 84
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 84
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Time frame: Baseline, Week 84
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Time frame: Baseline, Week 84
Change from Baseline in Height
Time frame: Baseline, Week 84
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Week 84
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Week 84
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Week 84
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)
Time frame: Baseline through Week 84
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
Oxnard, California, United States
Children's Hospital Colorado
Colorado Springs, Colorado, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, United States
William A. Shands Hospital at the University of Florida
Gainesville, Florida, United States
Florida Hospital- Center for Pediatric Research
Orlando, Florida, United States
...and 74 more locations