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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT07253285 (opens ClinicalTrials.gov in a new tab)Other idNN9838-4968Other idU1111-1299-4751Other id2023-509176-42Other id2023

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
460 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
26 countries

United States, Australia, Austria, Belgium, Bulgaria, China, Colombia, Croatia, Denmark, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, United Kingdom

Start
8 Jan 2026
Primary completion
20 Mar 2030 (estimated)
Completion
20 Sept 2033 (estimated)
First posted
28 Nov 2025
Last update posted
30 Sept 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262028203020322034
  1. Ph 3

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

    NCT07253285

    8 Jan 2026 to est. 20 Sept 2033

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • Placebo cagrilintideDrug
  • Placebo semaglutideDrug

Arms4

  • Experimental

    CagriSema

    Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks.

  • Experimental

    Semaglutide

    Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks.

  • Experimental

    Cagrilintide

    Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks.

  • Placebo comparator

    Placebo

    Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body mass index (BMI)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured in percentage (%).

Secondary outcomes(20)
  1. Relative change in body weight

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured in %.

  2. Change in BMI Standard Deviation Score (SDS)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as SDS score.

  3. Relative change in BMI

    Time frame · Baseline (week 0), week 68 and week 224

    Registry description

    Measured in %.

  4. Number of participants in weight category reduction

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  5. Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  6. Number of participants who achieved >=10% reduction of body weight (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  7. Number of participants who achieved >=15% reduction of body weight (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  8. Number of participants who achieved >=20% reduction of body weight (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  9. Number of participants who achieved >=25% reduction of body weight (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  10. Number of participants who achieved >=5% reduction of BMI (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  11. Number of participants who achieved >=10% reduction of BMI (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  12. Number of participants who achieved >=15% reduction of BMI (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  13. Number of participants who achieved >=20% reduction of BMI (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  14. Number of participants who achieved >=25% reduction of BMI (yes/no)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  15. Number of participants who achieved normal BMI

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  16. Number of participants who shifted from obese to non-obese BMI class

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as count of participants.

  17. Change in waist circumference

    Time frame · Baseline (week 0), week 68 and week 224

    Registry description

    Measured in centimeter (cm).

  18. Change in waist-to-height ratio

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured as ratio.

  19. Absolute change in total fat mass by dual energy X-ray absorption (DXA)

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured in kilograms (kg).

  20. Relative to baseline change in total fat mass by DXA

    Time frame · Baseline (week 0), week 68

    Registry description

    Measured in %.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 8 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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