A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Phase 3
460
about 7.7 years
8–18
34 sites in CA, FL, GA +16
What this study is about
This trial is testing how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. It has two parts: a main trial and an extension trial. In the main trial, participants will either get CagriSema (a new trial drug), cagrilintide (a new trial drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main trial will not take part in the extension trial. If participants take part in the extension trial, they will get either CagriSema or cagrilintide in this part of it.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Cagrilintide
- 2.Take Placebo cagrilintide
- 3.Take Placebo semaglutide
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
semaglutide (GLP-1 agonist; stimulates insulin release)
oral (Oral Tablet)
Primary: Relative change in body mass index (BMI)
Secondary: Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat, Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat, Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat, Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state, Change in Alanine Transaminase (ALT), Change in BMI Standard Deviation Score (SDS), Change in BMI percentage of the 95th percentile, Change in HbA1c (millimoles per mole [mmol/mol])
Endocrinology