CagriSema and cagrilintide for weight loss in children and teens with excess body weight
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
Run by Novo Nordisk A/S · NCT07253285 · Data updated 2026-11-12
This study will see if CagriSema or cagrilintide help children and teens (ages 8 to under 18) with excess body weight lose weight compared with semaglutide or a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Enrollment | 460 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 121 sites (Escondido, California and 120 other locations) |
| Status | Recruiting |
| Started | January 8, 2026 |
| Main results expected | March 20, 2030 |
| Study ends | September 20, 2033 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07253285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 8 to under 18 with BMI at or above the 95th percentile (or at or above the 85th percentile with an obesity-related complication) who can provide assent and have parental consent are the intended participants.
✕Probably not a fit
Children younger than 8 or 18 and older, those whose BMI is below the study thresholds, or those with contraindications to the study drugs are unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 randomized trial assigns participants to receive CagriSema, cagrilintide, semaglutide, or placebo, with treatment allocation decided by chance. The main study period is about 1 year and 6 months, and an optional extension can extend total participation to about 4 years and 10 months; participants assigned to semaglutide in the main study do not enter the extension. In the extension, participants receive either CagriSema or cagrilintide. Safety monitoring and regular visits will track weight, side effects, and other health outcomes throughout the study.
Why it matters
Potential benefit: If successful, these drugs could help children and adolescents achieve meaningful and sustained weight loss and lower obesity-related health risks.
How similar studies have gone: Other GLP-1 receptor agonists such as semaglutide have produced meaningful weight loss in adolescents and adults, so this trial builds on prior positive findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. * Type 1 diabetes or monogenic diabetes. For participants without T2D at screening the following exclusion criteria also apply * HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening. * Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening. For participants with T2D at screening the following exclusion criteria also apply * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire. * Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator. * Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. * Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Where it's running
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Neighborhood Healthcare
Escondido, California, United States Recruiting -
Encore Medical Research LLC
Hollywood, Florida, United States Recruiting -
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States Recruiting -
Encore Medical Research of Weston
Weston, Florida, United States Recruiting -
Children's Healthcare Atlanta
Atlanta, Georgia, United States Recruiting -
Columbus Research Foundation
Columbus, Georgia, United States Recruiting
Show 44 more locations
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Accel Research Sites-NeuroStudies
Decatur, Georgia, United States Recruiting -
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States Recruiting -
Solaris Clinical Research
Meridian, Idaho, United States Recruiting -
IU Health - Riley Physicians Endo-Diab
Indianapolis, Indiana, United States Recruiting -
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States Recruiting -
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States Recruiting -
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States Recruiting -
University of Minnesota
Minneapolis, Minnesota, United States Recruiting -
Synexus Clinical Research US-MN
Richfield, Minnesota, United States Recruiting -
SUNY Upstate Medical Univ - Syracuse
Syracuse, New York, United States Recruiting -
Valley Weight Loss Clinic
Fargo, North Dakota, United States Recruiting -
Centricity Research - Ohio
Columbus, Ohio, United States Recruiting -
PriMed Clinical Research
Dayton, Ohio, United States Recruiting -
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States Recruiting -
LifeDoc Health
Memphis, Tennessee, United States Recruiting -
DM Clinical
Houston, Texas, United States Recruiting -
The Texas Liver Institute
San Antonio, Texas, United States Recruiting -
Pinnacle Clinical Research
San Antonio, Texas, United States Recruiting -
Consano Clin Res-Shavano Park
Shavano Park, Texas, United States Recruiting -
Texas Valley Clinical Research
Weslaco, Texas, United States Recruiting -
AMR Clinical
Layton, Utah, United States Recruiting -
The Children's Hospital at Westmead - Clinical Research Centre
Westmead, New South Wales, Australia Recruiting -
Queensland Children's Hospital
South Brisbane, Queensland, Australia Recruiting -
Perth Children's Hospital
Nedlands, Western Australia, 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 -
UZA - Universitair Ziekenhuis Antwerpen
Edegem, Belgium Recruiting -
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, Bulgaria Recruiting -
SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
Sofia, Bulgaria Recruiting -
UMHAT Sveta Marina EAD, First Pediatric Clinic
Varna, Bulgaria Recruiting -
Capital Center for Children's Health, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, China Recruiting -
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou, Henan, China Recruiting -
Wuhan Children Hospital-Endocrine Genetics and Metabolism
Wuhan, Hubei, China Recruiting -
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
Wuhan, Hubei, China Recruiting -
Shandong Provincial Hospital-Pediatric
Jinan, Shandong, China Recruiting -
Children's Hospital of Fudan University-Endocrinology and Metabolism
Shanghai, Shanghai Municipality, China Recruiting -
Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
Chengdu, Sichuan, China Recruiting -
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, Denmark Recruiting -
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
Budapest, Hungary Recruiting -
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia Recruiting -
Hospital Sibu
Sibu, Sarawak, Malaysia Recruiting -
Kilostop Junior SRL
Bucharest, Romania Recruiting -
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, Romania Recruiting
+71 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.