A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Obesity,Overweight
Age
12 - 17
Phase
PHASE3
Participants Needed
150
Est. Completion Date
Oct 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT06075667
Study Number
I8F-MC-GPHP
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