DRUG
Tirzepatide
Administered SC
Status
Active, not recruiting
Phase
Phase 3
Enrollment
160
Locations
33
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Oct 10, 2023
Study start
Oct 16, 2023
Primary completion
Jun 2, 2026
Study completion
Jul 2029
Results posted
Not reported
Registry updated
Jun 29, 2026
Outcomes
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
Eligibility
Inclusion Criteria: * Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR * Have 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, with at least 1 weight-related comorbidity. * dyslipidemia * pre-hypertension * hypertension * nonalcoholic fatty liver disease * obstructive sleep apnea * prediabetes * documented preexisting condition of Type 2 Diabetes Participants with Type 2 Diabetes Mellitus (T2DM) * Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0% Exclusion Criteria: * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records. * Have Type 1 Diabetes * Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction. * Are prepubertal (Tanner stage 1). * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2 * Have a history of chronic or acute pancreatitis. * 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.
Study locations
Canada · Czechia · Israel · Italy · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.
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
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
Alberta Diabetes Institute
Edmonton, Alberta, Canada
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
ReFit Clinic
Olomouc, Olomouc Region, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, Czechia
Fakultni nemocnice v Motole
Prague, Praha 5, Czechia
Nemocnice Jihlava
Jihlava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Yitzhak Shamir Medical Center
Beer Yaacov, Central District, Israel
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Emek Medical Center
Afula, Northern District, Israel
Publications
No PMID-linked publications were present in this registry snapshot.
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