A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
- Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
- Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
EXCLUSION CRITERIA
Exclusion Criteria:
* Have undergone or plan to undergo a 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.
- 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
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,Weight Gain
Age
12 - 17
Phase
PHASE3
Participants Needed
300
Est. Completion Date
Jun 30, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT06439277
Study Number
I8F-MC-GPIX
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