Cagrilintide: Participants will receive cagrilintide subcutaneously.
Semaglutide: Participants will receive semaglutide subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide: Participants will receive placebo matched to semaglutide subcutaneously.
Study summary
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
Eligibility
Sex
ALL
Min age
8 Years
Max age
18 Years
Healthy volunteers
No
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.
* 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.
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 \[mmol/mol\]) 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.
Key exclusion criteria:
* 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.
* 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.
Primary outcome measure(s)
Relative change in body mass index (BMI) — Baseline (week 0), week 68 Measured in percentage (%).
Trial sites (121)
Facility
City
Region
Status
Neighborhood Healthcare
Escondido
California
Recruiting
Encore Medical Research LLC
Hollywood
Florida
Recruiting
Jacksonville Ctr for Clin Res
Jacksonville
Florida
Recruiting
Encore Medical Research of Weston
Weston
Florida
Recruiting
Children's Healthcare Atlanta
Atlanta
Georgia
Recruiting
Columbus Research Foundation
Columbus
Georgia
Recruiting
Accel Research Sites-NeuroStudies
Decatur
Georgia
Recruiting
Eastside Bariatric and Gen Surg
Snellville
Georgia
Recruiting
Solaris Clinical Research
Meridian
Idaho
Recruiting
IU Health - Riley Physicians Endo-Diab
Indianapolis
Indiana
Recruiting
Cotton O'Neil Clinical Research Center
Topeka
Kansas
Recruiting
Pennington Biomed Res Ctr
Baton Rouge
Louisiana
Recruiting
Barry J. Reiner, MD LLC
Baltimore
Maryland
Recruiting
University of Minnesota
Minneapolis
Minnesota
Recruiting
Synexus Clinical Research US-MN
Richfield
Minnesota
Recruiting
UBMD Physicians Group - Pediatrics - Conventus
Buffalo
New York
Not Yet Recruiting
SUNY Upstate Medical Univ - Syracuse
Syracuse
New York
Not Yet Recruiting
Advantage Clinical Trials
The Bronx
New York
Not Yet Recruiting
Valley Weight Loss Clinic
Fargo
North Dakota
Recruiting
Centricity Research - Ohio
Columbus
Ohio
Recruiting
PriMed Clinical Research
Dayton
Ohio
Recruiting
Children's Physicians OU
Oklahoma City
Oklahoma
Not Yet Recruiting
UPMC Child Hosp-Pittsburgh
Pittsburgh
Pennsylvania
Not Yet Recruiting
Prisma Health-Ped Endo
Greenville
South Carolina
Not Yet Recruiting
Coastal Carolina Research Ctr
North Charleston
South Carolina
Recruiting
Monument Health Clinical Rsrch
Rapid City
South Dakota
Not Yet Recruiting
LifeDoc Health
Memphis
Tennessee
Recruiting
DM Clinical
Houston
Texas
Recruiting
DM Clinical
San Antonio
Texas
Not Yet Recruiting
The Texas Liver Institute
San Antonio
Texas
Recruiting
Pinnacle Clinical Research
San Antonio
Texas
Recruiting
Consano Clin Res-Shavano Park
Shavano Park
Texas
Recruiting
Texas Valley Clinical Research
Weslaco
Texas
Recruiting
AMR Clinical
Layton
Utah
Recruiting
The Children's Hospital at Westmead - Clinical Research Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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