What we are researching
The purpose of this study is to find out how the study medicine, by itself and in combination with another medicine, works in helping children and adolescents with excess body weight lose weight.
Who may participate
Each clinical trial has its own requirements for who can participate, often called eligibility criteria. Some of the key criteria for this study are listed here. Discuss these requirements with your study doctor to determine if you may be eligible to participate. Additional criteria for your doctor to review can be found here NCT07253285.
Overweight or Obesity
For children 8-11 with a body mass index (BMI) equal to or above the 95th percentile
For adolescents 12-17 with a body mass index (BMI) equal to or above the 95th percentile or the 85th percentile with the presence of at least one obesity-related complication (such as type 2 diabetes, hypertension, dyslipidemia, etc.)
Overweight or Obesity
Have a body weight of greater than 45 kgs (about 99 lbs)
And have a history of at least one unsuccessful attempt to lose weight through a diet and exercise program
Age
8 to 17 years
Study Medicine
Once weekly injection
Number of study visits
Main - About 24 visits over a period of about 16 months
Extension - About 27 visits over a period of about 42 months
What to expect
If your study doctor determines that you are eligible and you decide to participate, you will be enrolled into the study.
The study consists of two phases: a main phase and an extension. In the main phase, you will be randomly assigned to receive either the study medicine, the combination of the study medicine and other medicine, the other medicine (by itself), or placebo (which has no active medicine in it). If you continue in the extension, you will receive either the study medicine or the combination medicine.
All study treatment options are given as injections under the skin, using an injection pen. Your study team will teach you how to use the injection pen.
The main phase will last about 1 year and 4 months, with a mix of in-person and phone visits every 2 to 4 weeks. Depending on the study group you join, three of the visits will require an overnight stay during the main phase. If you continue into the extension, your participation will last another 3 years and about 6 months, with a mix of in-person and phone visits every 4 to 13 weeks. Visits may include physical exams, lab tests and questionnaires to monitor your health and safety.
Call 866-867-7178 or email clinicaltrials@novonordisk.com to learn more
about the study and find out whether there is a participating study site near you.
When you call, please reference study 4968 or REDEFINE YOUNG
You may also choose to discuss this clinical trial with your healthcare provider.