Research Study on Cagrilintide and CagriSema for Children and Adolescents with Excess Body Weight
This research study is looking at how well two medications, Cagrilintide and CagriSema, help children and adolescents (ages 8 to 18) who have excess body weight. The study will compare these medications to Semaglutide (a drug already available) and a placebo (an inactive substance). You would be randomly assigned to one of these treatments. The main goal is to see how much your Body Mass Index (BMI) changes over 68 weeks. The study is currently unclear on its recruitment status and plans to enroll about 460 participants.
- Study design
- This is an interventional study that will enroll about 460 participants. You will be randomly assigned to receive Cagrilintide, Semaglutide, CagriSema, or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your Body Mass Index (BMI) will be measured at the beginning of the study and again at week 68.
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NCT07253285
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Recruiting
PHASE3Ages 8–18InterventionalTreatmentNovo Nordisk A/S
~460 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:CagrilintideSemaglutidePlacebo cagrilintidePlacebo semaglutide
At a glance
Recruiting sites
16 of 120 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in body mass index (BMI)
Measured over Baseline (week 0), week 68
Conditions
Where it's being run
120 sites across 65 statesTexas6
Georgia4
Bulgaria4
Israel4
Poland4
Romania4
Taiwan4
Florida3
Study leadership
- Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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.
Exclusion
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.
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.
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.
What this trial measures
- Relative change in body mass index (BMI)Baseline (week 0), week 68
Measured in percentage (%).