Barry J. Reiner, MD, LLC | Baltimore, MD
Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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.
Participants with Type 2 Diabetes Mellitus (T2DM)
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
Primary purpose
Allocation
Interventional model
Masking
150 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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