Clinical trial Recruiting at 65 sites Phase 3 Interventional Ages 8 to 18

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.

More Obesity trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages8 Years to 18 Years
SexAll
Enrollment460 (estimated)
SponsorNovo Nordisk A/S
Industry-sponsored
Locations121 sites (Escondido, California and 120 other locations)
StatusRecruiting
StartedJanuary 8, 2026
Main results expectedMarch 20, 2030
Study endsSeptember 20, 2033
Registry record updatedSeptember 30, 2026
Trial IDNCT07253285 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.