A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
This study, called SURMOUNT-ADOLESCENTS-2, is testing a new medicine called tirzepatide in teenagers aged 12 to 17. The aim is to see how well it helps adolescents who are overweight and have other health issues linked to their weight, such as high blood pressure or prediabetes. Participants will also follow healthy eating and exercise plans. The study wants to find out if tirzepatide can help improve body weight and reduce risks related to heart health. It will last about 76 weeks, with an opportunity for some participants to continue treatment for longer.
At a glance
What is this study about?
This research study is looking at a medicine called tirzepatide for young people aged 12 to 17 who are overweight and have other health conditions linked to their weight. These health conditions might include things like high blood pressure, early signs of diabetes (prediabetes), or high levels of fats in the blood. The main goal is to find out if tirzepatide, when used alongside advice on healthy eating and physical activity, can help young people manage their weight and improve factors that affect their heart health.
Researchers want to understand how safe and effective tirzepatide is for this group. The study will also compare tirzepatide to a 'placebo', which is a dummy medicine, to see the real effects of the active drug. The study is important because it could help doctors find new ways to support teenagers with weight-related health challenges.
For some participants who have already been part of a previous study and ended their treatment recently, there's a chance to receive tirzepatide for an additional period (up to about three years). This helps researchers gather more information about the long-term effects of the medicine.
Key takeaways
- Tests a new medicine (tirzepatide) for teenagers aged 12-17.
- Aims to help with weight and related health conditions.
- Includes healthy eating and exercise alongside the medicine.
- Compares the medicine to a dummy pill (placebo).
- Lasts about 1.5 years, with a chance for longer treatment for some.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To join this study, young people need to be between 12 and 17 years old. They must be considered overweight based on specific healthcare guidelines and also have at least two other health conditions linked to their weight, such as high blood pressure, prediabetes, or high blood fats. They should also have tried to lose weight before through diet without success.
There are certain reasons why someone might not be able to join. For example, if they have had or are planning to have weight-loss surgery, or if they have lost a lot of weight quickly in the last three months. Also, if they have certain types of diabetes (like type 1 or advanced type 2), or a history of specific pancreas or thyroid conditions, they wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 12 and 17 years old?
- Are you considered overweight by healthcare guidelines and also have at least two other weight-related health problems (like high blood pressure or prediabetes)?
- Have you tried losing weight through diet before without success?
- Have you NOT had or are you NOT planning to have weight-loss surgery?
- Do you NOT have type 1 diabetes or specific severe type 2 diabetes?
- Do you NOT have a personal or family history of certain thyroid or pancreas conditions?
What does participation involve?
If you decide to take part, the study will last about 76 weeks (around 1.5 years). During this time, you would have up to 23 visits to the clinic. At these visits, you'll likely have health checks, blood tests, and receive advice on healthy eating and physical activity. You would either receive the study medicine (tirzepatide) or a placebo (a dummy medicine). For those who were in a previous related study and stopped treatment recently, there's an opportunity to continue receiving tirzepatide for an extra 156 weeks (about 3 years) while continuing with lifestyle support. The research team will explain everything you need to know about the visits and treatments.
Potential risks and benefits
Locations (73)
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States· Active not recruiting
- Sutter Valley Medical Foundation (SVMF) Pediatric EndocrinologyVerified postcodeSacramento, United States· Active not recruiting
- Nemours Children's Health - DelawareVerified postcodeWilmington, United States· Active not recruiting
- CenExel iResearch, LLCVerified postcodeDecatur, United States· Recruiting
- Medical Research PartnersVerified postcodeAmmon, United States· Active not recruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoVerified postcodeChicago, United States· Active not recruiting
- Indiana University Health University HospitalVerified postcodeIndianapolis, United States· Active not recruiting
- UBMD PediatricsVerified postcodeBuffalo, United States· Active not recruiting
- SUNY Upstate Medical UniversityVerified postcodeSyracuse, United States· Active not recruiting
- Driscoll Children's HospitalVerified postcodeCorpus Christi, United States· Active not recruiting
- Epic Medical Research - DeSotoVerified postcodeDeSoto, United States· Active not recruiting
- Valley Institute of Research - Fort WorthVerified postcodeFort Worth, United States· Active not recruiting
Common questions
What is tirzepatide?
Tirzepatide is a medicine being tested to help manage weight and related health conditions in certain people.
What is a 'placebo'?
A placebo is a dummy medicine with no active drug. It helps researchers understand if the real medicine is having an effect.
How long will the study last?
The main part of the study lasts about 76 weeks, but some participants might have a chance to continue for an additional 156 weeks.
Will I still get help with healthy eating and exercise?
Yes, all participants will receive advice and support on healthy nutrition and physical activity throughout the study.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, and it won't affect your regular medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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