A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
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
Interventions
Cagrilintide
Semaglutide
Placebo cagrilintide
Placebo semaglutide
Conditions
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