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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

NCT07282613

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Type 2

Interventions: CagriSema (Cagrilintide B and Semaglutide I), Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Countries: United States, Argentina, Brazil, Colombia, India, Israel, Malaysia, Mexico

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.

Eligibility overview

Sex: ALL

Age: 10 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key 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.
* 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.

Key Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* 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.
* 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.

Locations (58)

New Haven, Connecticut, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Snellville, Georgia, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Southfield, Michigan, United States
Buffalo, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Rapid City, South Dakota, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Shavano Park, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Capital Federal, Buenos Aires, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
City of Buenos Aires, Argentina
Godoy Cruz, Argentina
San Miguel de Tucumán, Argentina
Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
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