A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT07253285

Run by

Novo Nordisk A/S

People needed

460

Starts

2026-01-08

Expected to finish

2033-09-20

Last updated by the study team

2026-07-17

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
• The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
• Male or female.
• Aged 8 to less than (<) 18 years at the time of signing the informed consent.
• Body mass index (BMI), at screening, corresponding to:
• Greater than or equal to (>=) 95th percentile for children aged 8 to < 12 years (Tanner stage 1-5)
• >= 95th percentile or >= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to < 18 years (Tanner stage 2-5).
• Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone.
• History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months.
• Body weight greater than (>) 45 kilograms (kg) at screening.
• For participants with T2D at screening the following inclusion criteria also apply
• Glycated haemoglobin (HbA1c) less than or equal to (<=)10.0 percent (%) (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening.
• Treatment with lifestyle intervention or treatment with metformin according to local label.
• Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening.
• Key exclusion criteria:
• Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
• Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
• Liposuction and/or abdominoplasty, if performed > 1 year before screening.
• Adjustable gastric banding, if the band has been removed > 1 year before screening.
• Intragastric balloon, if the balloon has been removed > 1 year before screening.
• Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year before screening.
• Uncontrolled thyroid disease.
• Endocrine, hypothalamic, or syndromic obesity.
• A self-reported (or by parent(s)/LAR, where applicable) change in body weight > 5 % within 90 days before screening irrespective of medical records.

Where it is running

• Children's Healthcare Atlanta — Atlanta, Georgia, United States (enrolling)
• Encore Medical Research of Weston — Weston, Florida, United States (enrolling)
• Perth Children's Hospital — Nedlands, Western Australia, Australia (enrolling)
• University College Hospital - Paediatric Services — London, United Kingdom (enrolling)
• IU Health - Riley Physicians Endo-Diab — Indianapolis, Indiana, United States (enrolling)
• The Children's Hospital at Westmead - Clinical Research Centre — Westmead, New South Wales, Australia (enrolling)
• DM Clinical — Houston, Texas, United States (enrolling)
• Queensland Children's Hospital — South Brisbane, Queensland, Australia (enrolling)
• Alder Hey Children's Hospital — Liverpool, United Kingdom (enrolling)
• Pennington Biomed Res Ctr — Baton Rouge, Louisiana, United States (enrolling)
• Birmingham Children's Hospital — Birmingham, United Kingdom (enrolling)
• Columbus Research Foundation — Columbus, Georgia, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Accel Research Sites-NeuroStudies — Decatur, Georgia, United States (enrolling)
• Eastside Bariatric and Gen Surg — Snellville, Georgia, United States (enrolling)
• Encore Medical Research LLC — Hollywood, Florida, United States (enrolling)
• AES Minneapolis DRS — Richfield, Minnesota, United States
• Prisma Health-Ped Endo — Greenville, South Carolina, United States
• Barry J. Reiner, MD LLC — Baltimore, Maryland, United States
• Jacksonville Ctr for Clin Res — Jacksonville, Florida, United States
• UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States
• Children's Physicians OU — Oklahoma City, Oklahoma, United States
• PriMed Clinical Research — Dayton, Ohio, United States
• Coastal Carolina Research Ctr — North Charleston, South Carolina, United States
• Centricity Research - Ohio — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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