A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight (NCT07253285)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Neighborhood Healthcare — Escondido, California
Age range: 8 Years to 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (120 Sites)
Showing the first 25 of 120 sites.
- Neighborhood Healthcare — Escondido, California
- Encore Medical Research LLC — Hollywood, Florida
- Jacksonville Ctr for Clin Res — Jacksonville, Florida
- Encore Medical Research of Weston — Weston, Florida
- Children's Healthcare Atlanta — Atlanta, Georgia
- Columbus Research Foundation — Columbus, Georgia
- Accel Research Sites-NeuroStudies — Decatur, Georgia
- Eastside Bariatric and Gen Surg — Snellville, Georgia
- Solaris Clinical Research — Meridian, Idaho
- IU Health - Riley Physicians Endo-Diab — Indianapolis, Indiana
- Cotton O'Neil Clinical Research Center — Topeka, Kansas
- Pennington Biomed Res Ctr — Baton Rouge, Louisiana
- Barry J. Reiner, MD LLC — Baltimore, Maryland
- University of Minnesota — Minneapolis, Minnesota
- AES Minneapolis DRS — Richfield, Minnesota
- UBMD Physicians Group - Pediatrics - Conventus — Buffalo, New York
- SUNY Upstate Medical Univ - Syracuse — Syracuse, New York
- Advantage Clinical Trials — The Bronx, New York
- Valley Weight Loss Clinic — Fargo, North Dakota
- Centricity Research - Ohio — Columbus, Ohio
- PriMed Clinical Research — Dayton, Ohio
- Children's Physicians OU — Oklahoma City, Oklahoma
- UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania
- Prisma Health-Ped Endo — Greenville, South Carolina
- Coastal Carolina Research Ctr — North Charleston, South Carolina
📞 Contact the Study Coordinator
Phone: (866) 867-7178
Email: clinicaltrials@novonordisk.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.