CagriSema for Type 2 Diabetes in Children and Adolescents
This research study is looking at how well a medicine called CagriSema (a combination of Cagrilintide B and Semaglutide I) helps children and teenagers with type 2 diabetes. The study wants to see if CagriSema can lower blood sugar (measured by HbA1c, or glycated hemoglobin) and body weight compared to a placebo (an inactive substance). You might be able to join if you are 10 to 18 years old and have type 2 diabetes. The study has two parts: in the first part, you will receive either CagriSema or placebo by chance, and in the second part, everyone will receive CagriSema. The study will last about 1 year and 3 months. The current status of the study is unclear.
- Study design
- This interventional study plans to enroll 80 participants aged 10-18. It has two parts: a double-blinded part where participants receive either CagriSema or placebo, and an open-label part where all participants receive CagriSema.
- What's involved
- The study will last for about 1 year and 3 months. You will receive CagriSema or placebo injections under the skin using a pen-injector.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, change in HbA1c, is measured from the start of the study to the end of the double-blinded treatment (week 26).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07282613
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
Not Yet Recruiting
PHASE3Ages 10–18InterventionalTreatmentNovo Nordisk A/S
~80 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:CagriSema (Cagrilintide B and Semaglutide I)Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
At a glance
Recruiting sites
0 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in glycated haemoglobin (HbA1c)
Measured over From baseline (week 0) to end of double-blinded treatment (week 26)
Conditions
Where it's being run
56 sites across 39 statesFlorida5
Israel5
São Paulo3
Georgia2
New York2
Texas2
Argentina2
India2
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.
Age 10 to \< 18 years at the time of signing the informed consent.
Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening.
Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:
Insulin (any regimen)
Metformin
SGLT2i
HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.
Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.
(a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening.
(b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used.
Known or previous diagnosis of hypoparathyroidism.
Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening.
Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment 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
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
What this trial measures
- Change in glycated haemoglobin (HbA1c)From baseline (week 0) to end of double-blinded treatment (week 26)
Measured as percentage (%) of HbA1c.