A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Public ClinicalTrials.gov record NCT07253285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07253285
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 460 participants
Conditions and interventions
Conditions
Interventions
- Cagrilintide Drug
- Semaglutide Drug
- Placebo cagrilintide Drug
- Placebo semaglutide Drug
Drug
Eligibility (public fields only)
- Age range
- 8 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2026
- Primary completion
- Mar 19, 2030
- Completion
- Sep 19, 2033
- Last update posted
- Aug 30, 2026
2026 – 2033
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neighborhood Healthcare | Escondido | California | 92025 | Recruiting |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | Recruiting |
| Jacksonville Ctr for Clin Res | Jacksonville | Florida | 32216 | Recruiting |
| Encore Medical Research of Weston | Weston | Florida | 33331 | Recruiting |
| Children's Healthcare Atlanta | Atlanta | Georgia | 30329 | Recruiting |
| Columbus Research Foundation | Columbus | Georgia | 31904 | Recruiting |
| Accel Research Sites-NeuroStudies | Decatur | Georgia | 30030 | Recruiting |
| Eastside Bariatric and Gen Surg | Snellville | Georgia | 30078 | Recruiting |
| Solaris Clinical Research | Meridian | Idaho | 83646 | Recruiting |
| IU Health - Riley Physicians Endo-Diab | Indianapolis | Indiana | 46202 | Recruiting |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | Recruiting |
| Pennington Biomed Res Ctr | Baton Rouge | Louisiana | 70808-4124 | Recruiting |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Synexus Clinical Research US-MN | Richfield | Minnesota | 55423 | Recruiting |
| UBMD Physicians Group - Pediatrics - Conventus | Buffalo | New York | 14203 | Not yet recruiting |
| SUNY Upstate Medical Univ - Syracuse | Syracuse | New York | 13210 | Not yet recruiting |
| Advantage Clinical Trials | The Bronx | New York | 10467 | Not yet recruiting |
| Valley Weight Loss Clinic | Fargo | North Dakota | 58104 | Recruiting |
| Centricity Research - Ohio | Columbus | Ohio | 43213 | Recruiting |
| PriMed Clinical Research | Dayton | Ohio | 45429 | Recruiting |
| Children's Physicians OU | Oklahoma City | Oklahoma | 73104 | Not yet recruiting |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Not yet recruiting |
| Prisma Health-Ped Endo | Greenville | South Carolina | 29615 | Not yet recruiting |
| Coastal Carolina Research Ctr | North Charleston | South Carolina | 29405 | Recruiting |
| Monument Health Clinical Rsrch | Rapid City | South Dakota | 57701 | Not yet recruiting |
| LifeDoc Health | Memphis | Tennessee | 38115 | Recruiting |
| DM Clinical | Houston | Texas | 77065 | Recruiting |
| DM Clinical | San Antonio | Texas | 78207 | Not yet recruiting |
| The Texas Liver Institute | San Antonio | Texas | 78215 | Recruiting |
| Pinnacle Clinical Research | San Antonio | Texas | 78222 | Recruiting |
| Consano Clin Res-Shavano Park | Shavano Park | Texas | 78231 | Recruiting |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | Recruiting |
| AMR Clinical | Layton | Utah | 84041 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 87 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07253285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07253285 live on ClinicalTrials.gov.