What this trial means for you
This study is recruiting now at 15 US sites. It's studying Tirzepatide, Placebo for obesity, weight gain.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. * Have history of at least 1 self-reported unsuccessful dietary effort to lose weight. * Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable). Exclusion Criteria: * Have undergone or plan to undergo a 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. * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state * Have type 2 diabetes or have a HbA1c \> 6.4% at screening * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Study sites by state
California
- Children's Hospital Los Angeles — Los Angeles · Active, not recruiting
- Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology — Sacramento · Active, not recruiting
Delaware
- Nemours Children's Health - Delaware — Wilmington · Active, not recruiting
Georgia
- CenExel iResearch, LLC — Decatur · Recruiting now
Idaho
- Medical Research Partners — Ammon · Active, not recruiting
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago · Active, not recruiting
Indiana
- Indiana University Health University Hospital — Indianapolis · Active, not recruiting
New York
- UBMD Pediatrics — Buffalo · Active, not recruiting
- SUNY Upstate Medical University — Syracuse · Active, not recruiting
Texas
- Driscoll Children's Hospital — Corpus Christi · Active, not recruiting
- Epic Medical Research - DeSoto — DeSoto · Active, not recruiting
- Valley Institute of Research - Fort Worth — Fort Worth · Active, not recruiting
- Consano Clinical Research, LLC — Shavano Park · Active, not recruiting
- Texas Valley Clinical Research — Weslaco · Active, not recruiting
Utah
- Alliance for Multispecialty Research, LLC — Layton · completed
View the official record on ClinicalTrials.gov →
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