Back to search results

A Study of Tirzepatide for Adolescents with Obesity

This study is testing a drug called tirzepatide in adolescents (ages 12-17) who have obesity and other weight-related health problems like high blood pressure (hypertension), prediabetes, or high triglycerides. The goal is to see how tirzepatide, along with healthy eating and exercise, affects body weight and heart health risks. Some participants will receive tirzepatide, while others will receive a placebo (an inactive substance). The study will measure changes in Body Mass Index (BMI) and improvements in weight-related health conditions over 72 weeks. We don't have information on the current recruitment status. You might be able to join if you have a high BMI for your age and sex, at least two weight-related health problems, and have tried to lose weight before.

Study design
This is an interventional study planning to enroll 300 participants. Participants will be randomly assigned to receive either tirzepatide or a placebo.
What's involved
The study will last approximately 76 weeks and may include up to 23 visits. Participants will also continue with lifestyle interventions like healthy nutrition and physical activity.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 72. Some participants may have the opportunity for an additional 156 weeks of treatment after the initial 72-week study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06439277

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

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Eli Lilly and Company
~300 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:TirzepatidePlacebo

At a glance

Recruiting sites
2 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Body Mass Index (BMI)
Measured over Baseline, Week 72
+1 more outcome measured

Conditions

Obesity
Weight Gain

Explore related trials

Obesity

Where it's being run

70 sites across 19 states
United Kingdom9
Israel8
France7
Argentina6
Texas5
Australia5
Mexico5
Spain5

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent Change from Baseline in Body Mass Index (BMI)Baseline, Week 72
  • A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined ComorbidityBaseline, Week 72