Testing CagriSema for Blood Sugar and Weight in Young People With Type 2 Diabetes
Tests CagriSema against placebo in children and teens with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Coyoacán, Cuauhtémoc, Monterrey, Puebla City, and San Nicolás de los Garza, MexicoSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 10 to under 18 who have type 2 diabetes and are overweight, to test how CagriSema affects blood sugar and body weight.
- Age
- 10 to under 18 years
- Sex
- Boys and girls can both join.
- Disease stage
- Type 2 diabetes diagnosed at least 30 days before screening. HbA1c 6.5% (48 mmol/mol)-11.0% (97 mmol/mol). Body weight 45 kg (99 lb) or more and BMI at or above the 85th percentile.
- Earlier treatment
- Diet and exercise counselling alone, or with a stable dose of insulin, metformin or an SGLT2 inhibitor. No other antidiabetic or anti-obesity medicine within 90 days before screening.
- Biomarker or test result
- Positive IA-2 or anti-GAD antibodies in the blood or in the medical history rule a person out.
Main reasons for not taking part
- Pregnant, breast-feeding, planning pregnancy, or able to become pregnant without highly effective contraception
- Any other antidiabetic or anti-obesity medicine within 90 days before screening
- Known or previous hypoparathyroidism
- Previous or planned obesity surgery or weight loss device, with some exceptions
- Positive IA-2 or anti-GAD antibodies
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 18 years old?
Source: NCT07282613, who can take part
Where in Mexico
- Instituto Nacional de PediatríaCoyoacán, MexicoContact: Novo NordiskNot yet recruiting
- UMAE CMN Siglo XXI Dept Endocrinología PediátricaCuauhtémoc, MexicoContact: Novo NordiskNot yet recruiting
- IECSI Centro de Investigación ClínicaMonterrey, MexicoContact: Novo NordiskNot yet recruiting
- Consultorio de Endocrinología y PediatríaPuebla City, MexicoContact: Novo NordiskNot yet recruiting
- Centro de Investigación y Control Metabólico S. C.San Nicolás de los Garza, MexicoContact: Novo NordiskNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07282613
- Record updated
- 19 October 2026
- Original description
The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.Read full original descriptionShow less
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes
The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.
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.
Exclusion: Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening; 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; 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; 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; Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method; 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.