A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity
3 other identifiers
interventional
460
24 countries
114
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Longer than P75 for phase_3
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 20, 2033
April 2, 2026
March 1, 2026
4.2 years
November 19, 2025
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body mass index (BMI)
Measured in percentage (%).
Baseline (week 0), week 68
Secondary Outcomes (73)
Relative change in body weight
Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)
Baseline (week 0), week 68
Relative change in BMI
Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction
Baseline (week 0), week 68
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)
Baseline (week 0), week 68
- +68 more secondary outcomes
Study Arms (4)
CagriSema
EXPERIMENTALParticipants 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.
Semaglutide
EXPERIMENTALParticipants 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.
Cagrilintide
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (119)
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, 15203, 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, 78229, United States
Consano Clin Res-Shavano Park
Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Wee Care Pediatrics
Syracuse, Utah, 84075, 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 - UZ Antwerpen - Kinderziekenhuis
Edegem, 2650, Belgium
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, 4002, Bulgaria
SHATPD - Prof. Ivan Mitev EAD
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
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
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, 34137, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, 37126, 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. - Hospital de Santo António
Porto, 4050-342, Portugal
Hospital CUF Porto S.A.
Porto, 4100-180, Portugal
ULS De Gaia/Espinho E.P.E. - Hospital Eduardo Santos Silva
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
Uppsala universitetssjukhus
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 District, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures. The main phase of the study is double blinded and followed by an open label extension phase.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
January 8, 2026
Primary Completion (Estimated)
March 20, 2030
Study Completion (Estimated)
September 20, 2033
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.