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Clinical Trials in the UK / NCT07253285
Recruiting Phase 3

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

NCT07253285 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-01-08
Last updated
2026-08-31

Condition(s) studied

OverweightObesity

Investigational drug(s) / intervention(s)

CagrilintideSemaglutidePlacebo cagrilintidePlacebo semaglutide

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)

Trial sites (121)

FacilityCityRegionStatus
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 Westmead New South Wales Recruiting
Queensland Children's Hospital South Brisbane Queensland Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
Universitätsklinik Kinder-Jugendheilkunde Innsbruck Innsbruck Austria Not Yet Recruiting
Universitätsklinik für Kinder und Jugendheilkunde Haus E Salzburg Austria Not Yet Recruiting
UZ Brussel - Universitair Ziekenhuis Brussel Brussels Belgium Not Yet Recruiting

+ 81 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in the UK

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Official registry record

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.

View NCT07253285 on ClinicalTrials.gov ↗ ← All trials in the UK