A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
NCT ID: NCT07253285
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
460 participants
INTERVENTIONAL
2026-01-08
2033-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks.
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.
Semaglutide
Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks.
Semaglutide
Participants will receive semaglutide subcutaneously.
Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks.
Cagrilintide
Participants will receive cagrilintide subcutaneously.
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo
Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks.
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
* 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.
8 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Neighborhood Healthcare
Escondido, California, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Children's Healthcare Atlanta
Atlanta, Georgia, United States
Columbus Research Foundation
Columbus, Georgia, United States
Accel Research Sites-NeuroStudies
Decatur, Georgia, United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
IU Health - Riley Physicians Endo-Diab
Indianapolis, Indiana, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
AES Minneapolis DRS
Richfield, Minnesota, United States
UBMD Physicians Group - Pediatrics - Conventus
Buffalo, New York, United States
SUNY Upstate Medical Univ - Syracuse
Syracuse, New York, United States
Jerome Med/Ped Ctr
The Bronx, New York, United States
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Centricity Research - Ohio
Columbus, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Children's Physicians OU
Oklahoma City, Oklahoma, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
Prisma Health-Ped Endo
Greenville, South Carolina, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States
Monument Health Clinical Rsrch
Rapid City, South Dakota, United States
LifeDoc Health
Memphis, Tennessee, United States
DM Clinical
Houston, Texas, United States
DM Clinical
San Antonio, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
Consano Clin Res-Shavano Park
Shavano Park, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Wee Care Pediatrics
Syracuse, Utah, United States
Westmead Children's Hospital- The Clinical Research Centre
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Perth Children's' Hospital
Nedlands, Western Australia, Australia
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, , Austria
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, , Austria
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, , Belgium
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem, , Belgium
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, , Bulgaria
SHATPD - Prof. Ivan Mitev EAD
Sofia, , Bulgaria
Medical center Children's Health EOOD
Sofia, , Bulgaria
MHAT "Sveta Marina"
Varna, , Bulgaria
Capital Center for Children's Health, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Wuhan Children Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Bethune Hospital of Jilin University-Pediatric
Changchun, Jilin, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Servicios de Salud Ips Suramericana S.A.S.
Medellín, Antioquia, Colombia
Fundación Santa Fe de Bogotá
Bogotá, , Colombia
Clinical Hospital Centre Rijeka
Rijeka, , Croatia
KBC "Sestre Milosrdnice"
Zagreb, , Croatia
Klinika Za Djecje Bolesti Zagreb_Pediatric department
Zagreb, , Croatia
Aalborg Universitetshospital - Børne og Ungeafdelingen
Aalborg, , Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, , Denmark
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
Budapest, , Hungary
Semmelweis Egyetem ÁOK
Budapest, , Hungary
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
Szeged, , Hungary
Rambam MC - Department of Pediatrics A
Haifa, , Israel
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, , Israel
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin, , Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
Milan, Lombardy, Italy
AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
Novara, Piedmont, Italy
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, , Italy
Hospital Tunku Azizah
Kampung Baru, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Sibu
Sibu, Sarawak, Malaysia
CHRISTUS - Latam Hub Excellence and Innovation Center
Monterrey, Nuevo León, Mexico
IECSI Centro de Investigación Clínica
Monterrey, Nuevo León, Mexico
Consultorio de Endocrinología y Pediatría
Puebla City, , Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Samodzielny Zespół Publicznych Zakładów Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Leśnym
Dziekanów Leśny, , Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, , Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, , Poland
Unidade Local de Saúde de Santo António, E.P.E
Porto, , Portugal
Hospital CUF Porto S.A.
Porto, , Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, , Portugal
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, , Romania
Kilostop Junior SRL
Bucharest, , Romania
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, , Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, , Romania
University Children's Hospital Tirsova
Belgrade, , Serbia
Institute for Mother and Child Health Care of Serbia
Belgrade, , Serbia
Institute for Health Care of Children and Adolescents
Novi Sad, , Serbia
Narodny Ustav Detskych Chorob
Bratislava, , Slovakia
Detska Fakultna nemocnica Kosice
Košice, , Slovakia
Narodny Endokrinologicky a diabetologicky ustav
Ľubochňa, , Slovakia
Hospital Vall d'Hebrón_Endocrinología pediatríca
Barcelona, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Barn och ungdomscentrum Västerbotten
Umeå, , Sweden
Uppsala universitetssjukhus
Uppsala, , Sweden
King Chulalongkorn Memorial Hospital_Ped-Nutrition
Bangkok, , Thailand
Thammasat Hospital_CRC
Pathum Thani, , Thailand
Birmingham Children's Hospital
Birmingham, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
University College London Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1299-4751
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509176-42
Identifier Type: OTHER
Identifier Source: secondary_id
NN9838-4968
Identifier Type: -
Identifier Source: org_study_id