Efficacy and Safety of Tirzepatide Once Weekly versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-ADOLESCENTS-2)

Clinical Trials

Offered by: Nemours Children's
Location: Delaware Valley

Trial Name

Efficacy and Safety of Tirzepatide Once Weekly versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

What is the trial about?

The study aims to learn whether the investigational study drug can manage weight in adolescent participants with obesity and related conditions, whether the investigational study drug works better than a fake study drug (placebo), and what are the possible side effects.

Who can participate?

Adolescents ages 12 through 17 years old diagnosed with obesity and at least two of the following conditions: high blood pressure, prediabetes and/or hypertriglyceridemia.

What is involved?

The screening period can last up to 6 weeks depending on your personal health care situation. The Dose Escalation and Study Treatment Period of the study, which may last for about 72 weeks, is when you receive either the drug being studied (tirzepatide), or a placebo (fake study drug) to compare how well they work. After you have finished with the study drug, the study doctor will continue to check on your health and you may have a blood and urine test. This is called the Follow-up Period, and it may last for about 4 weeks.  

People in this study usually have about 3 blood draws and 1 ECG during the screening. People in this study usually have about 8 blood draws, about 2 ECGs and 1 DXA during the study treatment period, but you might need to have more.