The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (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.
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Administered SC
Administered SC
Children's Hospital Los Angeles
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGSutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGNemours Children's Health - Delaware
Wilmington, Delaware, United States
ACTIVE_NOT_RECRUITINGCenExel iResearch, LLC
Decatur, Georgia, United States
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
Time frame: Baseline, Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
Time frame: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
Time frame: Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 72
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
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
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 72
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 72
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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Medical Research Partners
Ammon, Idaho, United States
ACTIVE_NOT_RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITINGIndiana University Health University Hospital
Indianapolis, Indiana, United States
ACTIVE_NOT_RECRUITINGUBMD Pediatrics
Buffalo, New York, United States
ACTIVE_NOT_RECRUITINGSUNY Upstate Medical University
Syracuse, New York, United States
ACTIVE_NOT_RECRUITINGDriscoll Children's Hospital
Corpus Christi, Texas, United States
ACTIVE_NOT_RECRUITING...and 63 more locations