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

What Was Tested

The trial (phase 3) is built around Tirzepatide.

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.

Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive placebo SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to people of any sex aged from 12 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: gastric bypass; sleeve gastrectomy; restrictive bariatric surgery, such as lap-band gastric banding, or.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-06-03 with completion listed for 2027-10.

It ran at 69 sites in United States (14), United Kingdom (9), Israel (8), France (7), Argentina (6) and Mexico (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 72).

It also tracked 12 secondary outcomes, for example Change from Baseline in Hemoglobin A1c (HbA1c), Percent Change from Baseline in Triglycerides, Change from Baseline in Systolic Blood Pressure (SBP), Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI), Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA) and Change from Baseline in Diastolic Blood Pressure (DBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 300 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.