Overview
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.
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.