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NCT07253285PHASE3Recruiting

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

Novo Nordisk A/S

Start Date

1/8/2026

Completion Date

9/20/2033

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 Criteria

Age Range: 8 years to 18 years

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.

Interventions

DRUG

Cagrilintide

DRUG

Semaglutide

DRUG

Placebo cagrilintide

DRUG

Placebo semaglutide

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Conditions

OverweightObesity

Locations

Neighborhood Healthcare

Escondido, California 92025

United States

Encore Medical Research LLC

Hollywood, Florida 33024

United States

Jacksonville Ctr for Clin Res

Jacksonville, Florida 32216

United States

Encore Medical Research of Weston

Weston, Florida 33331

United States

Children's Healthcare Atlanta

Atlanta, Georgia 30329

United States

Columbus Research Foundation

Columbus, Georgia 31904

United States

Accel Research Sites-NeuroStudies

Decatur, Georgia 30030

United States

Eastside Bariatric and Gen Surg

Snellville, Georgia 30078

United States

Solaris Clinical Research

Meridian, Idaho 83646

United States

IU Health - Riley Physicians Endo-Diab

Indianapolis, Indiana 46202

United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas 66606

United States

Pennington Biomed Res Ctr

Baton Rouge, Louisiana 70808-4124

United States

Barry J. Reiner, MD LLC

Baltimore, Maryland 21229

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

AES Minneapolis DRS

Richfield, Minnesota 55423

United States

UBMD Physicians Group - Pediatrics - Conventus

Buffalo, New York 14203

United States

SUNY Upstate Medical Univ - Syracuse

Syracuse, New York 13210

United States

Advantage Clinical Trials

The Bronx, New York 10467

United States

Valley Weight Loss Clinic

Fargo, North Dakota 58104

United States

Centricity Research - Ohio

Columbus, Ohio 43213

United States

PriMed Clinical Research

Dayton, Ohio 45429

United States

Children's Physicians OU

Oklahoma City, Oklahoma 73104

United States

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

Prisma Health-Ped Endo

Greenville, South Carolina 29615

United States

Coastal Carolina Research Ctr

North Charleston, South Carolina 29405

United States

Monument Health Clinical Rsrch

Rapid City, South Dakota 57701

United States

LifeDoc Health

Memphis, Tennessee 38115

United States

DM Clinical

Houston, Texas 77065

United States

DM Clinical

San Antonio, Texas 78207

United States

The Texas Liver Institute

San Antonio, Texas 78215

United States

Pinnacle Clinical Research

San Antonio, Texas 78222

United States

Consano Clin Res-Shavano Park

Shavano Park, Texas 78231

United States

Texas Valley Clinical Research

Weslaco, Texas 78596

United States

AMR Clinical

Layton, Utah 84041

United States

The Children's Hospital at Westmead - Clinical Research Centre

Westmead, New South Wales 2145

Australia

Queensland Children's Hospital

South Brisbane, Queensland 4101

Australia

Perth Children's Hospital

Nedlands, Western Australia 6009

Australia

Universitätsklinik Kinder-Jugendheilkunde Innsbruck

Innsbruck, 6020

Austria

Universitätsklinik für Kinder und Jugendheilkunde Haus E

Salzburg, 5020

Austria

UZ Brussel - Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

UZA - Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics

Plovdiv, 4001

Bulgaria

SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases

Sofia, 1606

Bulgaria

Medical center Children's Health EOOD

Sofia, 1618

Bulgaria

UMHAT Sveta Marina EAD, First Pediatric Clinic

Varna, 9010

Bulgaria

Capital Center for Children's Health, Capital Medical University

Beijing, Beijing Municipality 100020

China

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality 100045

China

Henan Children's Hospital Zhengzhou Children's Hospital

Zhengzhou, Henan 450018

China

Wuhan Children Hospital

Wuhan, Hubei 430019

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430022

China

The First Bethune Hospital of Jilin University-Pediatric

Changchun, Jilin 130021

China

Shandong Provincial Hospital-Pediatric

Jinan, Shandong 250098

China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality 201102

China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan 610031

China

Servicios de Salud Ips Suramericana S.A.S.

Medellín, Antioquia 05001

Colombia

Fundación Santa Fe de Bogotá

Bogotá, 110111

Colombia

Clinical Hospital Centre Rijeka_Pediatric

Rijeka, 51 000

Croatia

KBC "Sestre Milosrdnice"

Zagreb, 10 000

Croatia

Klinika Za Djecje Bolesti Zagreb_Endocrinology

Zagreb, 10000

Croatia

Aalborg Universitetshospital - Børne og Ungeafdelingen

Aalborg, 9000

Denmark

Holbæk Sygehus - Børne- og Ungeafdelingen

Holbæk, 4300

Denmark

Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő

Budapest, 1023

Hungary

Semmelweis Egyetem ÁOK

Budapest, 1083

Hungary

Szegedi Tudományegyetem Gyermekgyógyászati Klinika

Szeged, 6720

Hungary

Endolife Specialty Hospitals

Guntur, Andhra Pradesh 522001

India

BAPS Pramukh Swami Hospital

Surat, Gujarat 395009

India

Indira Gandhi Institute of child health

Bangalore, Karnataka 560011

India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi 110060

India

Maulana Azad Medical College

Delhi, New Delhi 110002

India

Regency Hospital

Kanpur, Uttar Pradesh 208006

India

Institute of Child Health

Kolkata, West Bengal 700017

India

Excel Endocrine Centre

Kolhāpur, 416008

India

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029

India

Rambam MC - Department of Pediatrics A

Haifa, 31096

Israel

Shaare Zedek MC - Endocrinology Department

Jerusalem, 9103102

Israel

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, 49202

Israel

Shamir MC - Pediatric and Adolescents Endocrinology unit

Ẕerifin, 7033001

Israel

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia

Milan, Lombardy 20122

Italy

AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria

Novara, Piedmont 28100

Italy

A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B

Verona, Veneto 37126

Italy

IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica

Trieste, 34137

Italy

Hospital Tunku Azizah

Kampung Baru, Kuala Lumpur 50300

Malaysia

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur 59100

Malaysia

Hospital Sibu

Sibu, Sarawak 96000

Malaysia

CHRISTUS - Latam Hub Excellence and Innovation Center

Monterrey, Nuevo León 64060

Mexico

IECSI Centro de Investigación Clínica

Monterrey, Nuevo León 64310

Mexico

Consultorio de Endocrinología y Pediatría

Puebla City, 72190

Mexico

Jeroen Bosch Zkh

's-Hertogenbosch, 5223 GZ

Netherlands

Meander MC

Amersfoort, 3813 TZ

Netherlands

Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym

Dziekanów Leśny, 05-092

Poland

Uniwersytecki Szpital Kliniczny w Opolu

Opole, 45-401

Poland

Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

Rzeszów, 35-301

Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, 41-800

Poland

ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria

Porto, 4050-651

Portugal

CUF Porto_Serviço de Pediatria

Porto, 4100-180

Portugal

ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos

Vila Nova de Gaia, 4434-502

Portugal

Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare

Baia Mare, 430031

Romania

Kilostop Junior SRL

Bucharest, 010073

Romania

Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"

Bucharest, 041451

Romania

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, 300226

Romania

University Children's Hospital Tirsova

Belgrade, 11000

Serbia

Institute for Mother and Child Health Care of Serbia

Belgrade, 11070

Serbia

Institute for Health Care of Children and Adolescents

Novi Sad, 21000

Serbia

Narodny Ustav Detskych Chorob

Bratislava, 833 40

Slovakia

Detska Fakultna nemocnica Kosice

Košice, 040 01

Slovakia

Narodny Endokrinologicky a diabetologicky ustav

Ľubochňa, 03491

Slovakia

Hospital Vall d'Hebrón_Endocrinología pediatríca

Barcelona, 08035

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950

Spain

Hospital Universitario Virgen del Rocío

Seville, 41013

Spain

Barn och ungdomscentrum Västerbotten - NU

Umeå, 907 37

Sweden

Akademiska barnsjukhuset - klinisk forskningsmottagning

Uppsala, 75185

Sweden

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, 833

Taiwan

Chung Shan Medical University Hospital

Taichung, 402

Taiwan

Taipei Mackay Children's Hospital

Taipei, 104

Taiwan

Chang Gung Memorial Hospital Linkou-Dept of Pediatrics

Taoyuan, 333

Taiwan

King Chulalongkorn Memorial Hospital_Ped-Nutrition

Bangkok, 10300

Thailand

Thammasat Hospital_CRC

Pathum Thani, 12120

Thailand

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Alder Hey Children's Hospital

Liverpool, L12 2AP

United Kingdom

University College Hospital - Paediatric Services

London, NW1 1BU

United Kingdom