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

460 patients around the world

Available in United States, Mexico, Colombia

Novo Nordisk A/S

3Research sites

460Patients around the world

This study is for people with

Obesity

Requirements for the patient

To 18 Years

All Gender

Medical requirements

: Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities.
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 less than 12 years (Tanner stage 1-5).
Greater than or equal to 95th percentile or greater than or equal to 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 less than 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 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) 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.

: Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
Previous or planned obesity treatment with surgery or a weight loss device.
Liposuction and/or abdominoplasty, if performed more than 1 year before screening.
Adjustable gastric banding, if the band has been removed more than 1 year before screening.
Intragastric balloon, if the balloon has been removed more than 1 year before screening.
Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year before screening.
Uncontrolled thyroid disease.
Endocrine, hypothalamic, or syndromic obesity.
A self-reported change in body weight greater than 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.

Sites

Fundación Santa Fe de Bogotá

calle 119 #7 75, Bogotá

CHRISTUS Centro de Excelencia en Investigación - CEI (Obispado)

Miguel Hidalgo y Costilla 2525, Obispado, 64060 Monterrey, N.L.

IECSI S.C.

C. Jdn. de Las Delicias 3976, Lincoln Unidad Residencial, 64310 Monterrey, N.L

SponsorNovo Nordisk A/S

Study typeInterventional

Conditions

Obesity

Requirements

To 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07253285