A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Condition(s) studied
Investigational drug(s) / intervention(s)
Cagrilintide: Participants will receive cagrilintide subcutaneously.
Semaglutide: Participants will receive semaglutide subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide: Participants will receive placebo matched to semaglutide subcutaneously.
Study summary
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study 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 study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
Eligibility
Primary outcome measure(s)
- Relative change in body mass index (BMI) — Baseline (week 0), week 68
Measured in percentage (%).
Trial sites (121)
| Facility | City | Region | Status |
|---|---|---|---|
| Neighborhood Healthcare | Escondido | California | Recruiting |
| Encore Medical Research LLC | Hollywood | Florida | Recruiting |
| Jacksonville Ctr for Clin Res | Jacksonville | Florida | Recruiting |
| Encore Medical Research of Weston | Weston | Florida | Recruiting |
| Children's Healthcare Atlanta | Atlanta | Georgia | Recruiting |
| Columbus Research Foundation | Columbus | Georgia | Recruiting |
| Accel Research Sites-NeuroStudies | Decatur | Georgia | Recruiting |
| Eastside Bariatric and Gen Surg | Snellville | Georgia | Recruiting |
| Solaris Clinical Research | Meridian | Idaho | Recruiting |
| IU Health - Riley Physicians Endo-Diab | Indianapolis | Indiana | Recruiting |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | Recruiting |
| Pennington Biomed Res Ctr | Baton Rouge | Louisiana | Recruiting |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Synexus Clinical Research US-MN | Richfield | Minnesota | Recruiting |
| UBMD Physicians Group - Pediatrics - Conventus | Buffalo | New York | Not Yet Recruiting |
| SUNY Upstate Medical Univ - Syracuse | Syracuse | New York | Recruiting |
| Advantage Clinical Trials | The Bronx | New York | Not Yet Recruiting |
| Valley Weight Loss Clinic | Fargo | North Dakota | Recruiting |
| Centricity Research - Ohio | Columbus | Ohio | Recruiting |
| PriMed Clinical Research | Dayton | Ohio | Recruiting |
| Children's Physicians OU | Oklahoma City | Oklahoma | Not Yet Recruiting |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| Prisma Health-Ped Endo | Greenville | South Carolina | Not Yet Recruiting |
| Coastal Carolina Research Ctr | North Charleston | South Carolina | Recruiting |
| Monument Health Clinical Rsrch | Rapid City | South Dakota | Not Yet Recruiting |
| LifeDoc Health | Memphis | Tennessee | Recruiting |
| DM Clinical | Houston | Texas | Recruiting |
| DM Clinical | San Antonio | Texas | Not Yet Recruiting |
| The Texas Liver Institute | San Antonio | Texas | Recruiting |
| Pinnacle Clinical Research | San Antonio | Texas | Recruiting |
| Consano Clin Res-Shavano Park | Shavano Park | Texas | Recruiting |
| Texas Valley Clinical Research | Weslaco | Texas | Recruiting |
| AMR Clinical | Layton | Utah | Recruiting |
| The Children's Hospital at Westmead - Clinical Research Centre | Westmead | New South Wales | Recruiting |
| Queensland Children's Hospital | South Brisbane | Queensland | Recruiting |
| Perth Children's Hospital | Nedlands | Western Australia | Recruiting |
| Universitätsklinik Kinder-Jugendheilkunde Innsbruck | Innsbruck | Austria | Recruiting |
| Universitätsklinik für Kinder und Jugendheilkunde Haus E | Salzburg | Austria | Recruiting |
| UZ Brussel - Universitair Ziekenhuis Brussel | Brussels | Belgium | Recruiting |
+ 81 more sites — see the full list on the official registry below.
On this site
📄 Ozempic (semaglutide) drug profile →More Novo Nordisk A/S trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07253285 on ClinicalTrials.gov ↗ ← All trials in Italy