What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide, Placebo for obesity, overweight.
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 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.
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 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 sites by state
Georgia
- CenExel iResearch, LLC — Decatur
Idaho
- Solaris Clinical Research — Meridian
Kansas
- Cotton O'Neil Diabetes & Endocrinology — Topeka
Louisiana
- Pennington Biomedical Research Center — Baton Rouge
Maryland
- Barry J. Reiner, MD, LLC — Baltimore
Minnesota
- M Health Fairview - Delaware Clinical Research Unit (DCRU) — Minneapolis
Missouri
- Washington University School of Medicine — St Louis
Ohio
- Aventiv Research Inc — Columbus
- PriMED Clinical Research — Dayton
Tennessee
- Vanderbilt Health One Hundred Oaks — Nashville
View the official record on ClinicalTrials.gov →
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