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RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 23 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last approximately 76 weeks and may include up to 23 visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how tirzepatide, along with healthy eating and physical activity, affects body weight and risk factors for heart disease. It is for teens with obesity and at least two specified weight-related health problems. The study lasts about 76 weeks, with up to 23 visits, and some participants may qualify for longer treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure based on height and weight, at or above the 95th percentile for your age and sex. This is the study's cutoff for obesity.
  • Have at least two of these: high blood pressure, prediabetes (blood sugar above normal but below the diabetes range), or high triglycerides (a type of fat in the blood).
  • Report at least one past attempt to lose weight through diet that did not work.
  • Be able to give signed agreement to join, through a legal representative or the teen's own agreement, as required.

Who can't join

  • Have had, or plan to have during the study, a weight-loss procedure, such as gastric bypass, stomach sleeve surgery, or a stomach band.
  • You, your parent, or your legal guardian report that you lost more than 11 pounds (5 kg) in the 90 days before screening.
  • Have type 1 diabetes or a history of ketoacidosis (dangerous acid buildup in the blood) or a hyperosmolar state (very high blood sugar with severe loss of body fluids).
  • Have type 2 diabetes or an HbA1c above 6.4% at screening. HbA1c measures average blood sugar over time.
  • Have a history of pancreatitis, or swelling of the pancreas, whether sudden or long-lasting.
  • You or a family member have had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in glands that make hormones.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (14)

CA

DE

ID

IL

IN

NY

TX

UT