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CagriSema and cagrilintide for weight loss in children and teens with excess body weight

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

Phase 3 Interventional Novo Nordisk A/S · NCT07253285

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

PhasePhase 3
Study typeInterventional
Enrollment460 (estimated)
Ages8 Years to 18 Years
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations119 sites (Escondido, California and 118 other locations)
Trial IDNCT07253285 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Escondido, California and 118 other locations

+69 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions OverweightObesity
Last reviewed 2026-06-13 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.