Sutter Health | Center of Excellence in Diabetes and Endocrinology
Status and phase
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Study type
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to
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
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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