Active not recruitingPHASE4INTERVENTIONAL

STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

This study, called 'STEP TEENS Weight Maintenance,' investigates how well a medicine called semaglutide helps teenagers who are overweight to lose weight and then keep that weight off. The medicine is given as a weekly injection, similar to how some people with diabetes take their insulin, using a thin needle in the stomach, thighs, or upper arms. All participants in the study will receive this semaglutide treatment for a minimum of three years. The main goal is to understand its effectiveness for long-term weight management in young people. This research is important because it seeks new, safe ways to support teenagers in achieving and maintaining a healthy weight.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Novo Nordisk A/S

Enrolment target

500

Start

17 Sep 2024

Estimated completion

15 Nov 2031

Obesity

What is this study about?

This research study, called 'STEP TEENS Weight Maintenance,' is all about helping teenagers aged 12 to 15 who are living with overweight or obesity. The main aim is to see how well a medicine called semaglutide helps them not only to lose weight but, crucially, to keep that weight off long-term. Maintaining weight loss can be challenging, so this study focuses on understanding if semaglutide can provide lasting support.

Semaglutide is a medication that's already used in adults for weight management. In this study, it's being tested specifically for teenagers. All participants will receive semaglutide, given as a simple, weekly injection. Think of it like a small jab with a very thin needle, which can be done in the tummy, thighs, or upper arms. This isn't a short-term trial; everyone involved will receive the treatment for at least three years, allowing researchers to see its effects over a longer period.

The findings from this study are really important because they could help healthcare professionals better support teenagers managing their weight in the future. By studying how well semaglutide works for this age group, researchers hope to develop new, effective ways to help young people achieve and maintain a healthy weight, which is vital for their overall health and well-being.

Key takeaways

This study evaluates semaglutide for weight loss and maintenance in teenagers.
Participants will be teenagers aged 12 to 15 with excess body weight.
The treatment involves a weekly semaglutide injection for at least three years.
It aims to understand long-term effectiveness for weight management in this age group.
Participation requires parental consent and teen's agreement.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, teenagers must be between 12 and under 15 years old when they first give their consent. They also need to have a Body Mass Index (BMI) that falls into the range considered overweight or obese for their age, specifically at or above the 95th percentile. Additionally, their body weight must be over 60 kg (about 9 stone 6 pounds) when screened for the study.

There are also some things that would mean a teenager couldn't take part. This includes if they haven't started puberty yet (Tanner stage 1), or if they've used other weight loss medications in the past three months. Also, if they've had or plan to have weight loss surgery or certain weight loss devices (like gastric banding or balloons) within the last year, or during the study, they wouldn't be eligible.

Finally, teenagers with certain medical conditions, such as specific hormone problems, type 1 or type 2 diabetes, or certain genetic conditions linked to obesity, would not be able to join. These criteria help ensure the study is safe and that researchers can get clear results about semaglutide's effects on this specific group.

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.

Is the teenager 12, 13, or 14 years old?
Does the teenager have a BMI considered overweight or obese for their age (95th percentile or higher for age and sex)?
Does the teenager weigh more than 60 kg (about 9 stones 6 pounds)?
Has the teenager NOT used any other weight loss medication in the last 3 months?
Has the teenager NOT had weight loss surgery or devices installed (or removed in the last year)?
Does the teenager NOT have type 1 or type 2 diabetes or certain hormone conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, your commitment will be for at least three years. Throughout this time, you will receive semaglutide as a weekly injection. This injection is given using a thin needle, typically in the stomach, thighs, or upper arms. You will have regular appointments for assessments and to monitor your progress and well-being. Detailed information about the number of visits and specific tests will be provided if you are suitable for the study. The total duration of active treatment and follow-up will be outlined clearly before you make any decision to participate.

Potential risks and benefits

Participating in this study might offer the potential benefit of helping with weight loss and maintaining it, which could improve overall health. However, like all medications, semaglutide can have side effects, which would be explained fully before you decide to take part. There's also the chance the treatment might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, and your doctors and the study team will always respect your decision.

Locations (93)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Neighborhood Healthcare
Verified postcode
Escondido, United States
Clinical Neuroscience Solution
Verified postcode
Orlando, United States
TMH Physician Partners Endo
Verified postcode
Tallahassee, United States
Children's Healthcare Atlanta
Verified postcode
Atlanta, United States
Columbus Research Foundation
Verified postcode
Columbus, United States
Eastside Bariatric and Gen Surg
Verified postcode
Snellville, United States
Solaris Clinical Research
Verified postcode
Meridian, United States
Synexus Clinical Research US Inc.-Chicago
Verified postcode
Chicago, United States
Indiana University Hospital
Verified postcode
Indianapolis, United States
University Of Iowa Hospitals and Clinics
Verified postcode
Iowa City, United States
Pennington Biom Res Ctr
Verified postcode
Baton Rouge, United States
Barry J. Reiner, MD LLC
Verified postcode
Baltimore, United States

Common questions

What is semaglutide?

Semaglutide is a medicine given as a weekly injection. It helps regulate appetite and has been shown to help with weight loss in adults, and this study is testing it in teenagers.

How is the medicine given?

The medicine is given as a weekly injection with a very thin needle, typically into the skin of your stomach, thighs, or upper arms.

How long will I be in the study?

If you join, you will receive the semaglutide treatment for a minimum of three years.

Can I leave the study if I change my mind?

Yes, you are completely free to leave the study at any point, for any reason, and it will not affect your medical care.

Will I get help with healthy eating and exercise?

While the study focuses on the medication, details about additional support, if any, would be provided to you by the study team.