The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Participants who have completed the primary 72-week GPHP 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Administered SC
Administered SC
CenExel iResearch, LLC
Decatur, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, United States
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Percentage of Participants with ≥5% BMI Reduction
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 in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
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 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
Time frame: Baseline, Week 72
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 72
Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
AUC is presented as a single average measure of AUC across the study duration.
Time frame: Baseline through Week 72
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M Health Fairview - Delaware Clinical Research Unit (DCRU)
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Aventiv Research Inc
Columbus, Ohio, United States
PriMED Clinical Research
Dayton, Ohio, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
...and 23 more locations