A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Recruiting · 40 sites across 8 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Teens with obesity based on BMI at or above the 95th percentile for age and sex on a growth chart
- •Teens with obesity plus at least 2 weight-related health problems such as high blood pressure, prediabetes, and/or high triglycerides
- •Teens who have tried at least 1 diet effort to lose weight but it did not work
- •Teens who can give signed consent/assent through a legal representative or the study participant (when applicable)
🚫 You may not be able to join if…
- •Teens planning to have or who have had weight-loss procedures during the study (like gastric bypass or sleeve gastrectomy)
- •Teens with more than a 5 kg (11 lb) body weight loss within 90 days before screening (even if not confirmed by medical records)
- •Teens with type 1 diabetes, or a past episode of ketoacidosis or hyperosmolar state
- •Teens with type 2 diabetes, or whose HbA1c is greater than 6.4% at screening
- •Teens with a history of pancreatitis, or a family/personal history of medullary thyroid cancer or MEN2 (multiple endocrine neoplasia syndrome type 2)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adolescents with obesity on age- and sex-specific growth charts (BMI ≥95th percentile)
- ✓Also have at least 2 weight-related comorbidities (like hypertension, prediabetes, high triglycerides)
- ✓Tried to lose weight with diet but it was unsuccessful
- ✓Not planning weight-loss surgery and no recent large weight loss before screening
- ✓Not have type 1 diabetes, pancreatitis history, or certain thyroid/MEN2 risks
- !Some conditions may not be a fit: Type 2 diabetes
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 72 weeks (~17 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 72 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: Tirzepatide
- Drug: Placebo
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Eli Lilly and Company
Overseen by 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)
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06439277 · Locations: California · Delaware · Idaho · Illinois · Indiana · New York · Texas · Utah