A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Launched by ELI LILLY AND COMPANY · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called SURMOUNT-ADOLESCENTS-2, is studying a medication called tirzepatide to see how it helps adolescents with obesity and related health issues, like high blood pressure or prediabetes. The goal is to find out if tirzepatide, along with healthy eating and exercise, can help these young people lose weight and improve their heart health. The study will take about 76 weeks and may involve up to 23 visits to a clinic.

To participate, adolescents must be between the ages of 12 and 18 and have a body mass index (BMI) that is above the 95th percentile for their age and sex, meaning they are considered obese. They should also have at least two weight-related health conditions, like high blood pressure or prediabetes, and have tried to lose weight before without success. However, those who have had weight-loss surgery or significant recent weight loss, as well as individuals with certain medical conditions like type 1 diabetes, cannot join the study. Participants can expect regular check-ups and support throughout the study to help them on their weight loss journey.

Gender

ALL

Eligibility 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:
• • 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

Trial Officials