Not Yet Enrolling

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

I8F-MC-GPIX -

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.

Trial Summary

Age Range
12 - 17 years
Conditions the trial is for
Obesity
What the trial is testing?
tirzepatide
Could I receive a Placebo?
Yes
Enrollment Goal
300
Trial Dates
Jun 1, 2024 - Jun 2027
How long will I be in the trial?
The study will last approximately 76 weeks and may include up to 23 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Be 12 to 17 years

  • Have been diagnosed with obesity ( a BMI equal to or above the 95th percentile for age and sex on CDC-NCHS 2022) with at least 2 weight related comorbidities (high blood pressure, abnormal lipids or prediabetes)

  • Have not been able to lose weight with healthy diet and physical activity

  • Have started puberty

Participants Must Not:

  • Have had or plan to have a weight loss surgery during the study

  • Have lost more than 5 kg (11 lbs) in the 90 days before screening

  • Have Type 1 Diabetes

  • Have Type 2 Diabetes

  • Have a history of pancreatitis.

  • Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2

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