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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

Status: Recruiting
Location: See all (119) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Neighborhood Healthcare
NOT_YET_RECRUITING
Escondido
Florida
Encore Medical Research LLC
RECRUITING
Hollywood
Jacksonville Ctr for Clin Res
NOT_YET_RECRUITING
Jacksonville
Encore Medical Research of Weston
RECRUITING
Weston
Georgia
Children's Healthcare Atlanta
RECRUITING
Atlanta
Columbus Research Foundation
RECRUITING
Columbus
Accel Research Sites-NeuroStudies
RECRUITING
Decatur
Eastside Bariatric and Gen Surg
RECRUITING
Snellville
Idaho
Solaris Clinical Research
NOT_YET_RECRUITING
Meridian
Indiana
IU Health - Riley Physicians Endo-Diab
RECRUITING
Indianapolis
Kansas
Cotton O'Neil Clinical Research Center
NOT_YET_RECRUITING
Topeka
Louisiana
Pennington Biomed Res Ctr
RECRUITING
Baton Rouge
Maryland
Barry J. Reiner, MD LLC
NOT_YET_RECRUITING
Baltimore
Minnesota
University of Minnesota
RECRUITING
Minneapolis
AES Minneapolis DRS
NOT_YET_RECRUITING
Richfield
North Dakota
Valley Weight Loss Clinic
NOT_YET_RECRUITING
Fargo
New York
UBMD Physicians Group - Pediatrics - Conventus
NOT_YET_RECRUITING
Buffalo
SUNY Upstate Medical Univ - Syracuse
NOT_YET_RECRUITING
Syracuse
Advantage Clinical Trials
NOT_YET_RECRUITING
The Bronx
Ohio
Centricity Research - Ohio
NOT_YET_RECRUITING
Columbus
PriMed Clinical Research
NOT_YET_RECRUITING
Dayton
Oklahoma
Children's Physicians OU
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
UPMC Child Hosp-Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Prisma Health-Ped Endo
NOT_YET_RECRUITING
Greenville
Coastal Carolina Research Ctr
NOT_YET_RECRUITING
North Charleston
South Dakota
Monument Health Clinical Rsrch
NOT_YET_RECRUITING
Rapid City
Tennessee
LifeDoc Health
NOT_YET_RECRUITING
Memphis
Texas
DM Clinical
RECRUITING
Houston
DM Clinical
NOT_YET_RECRUITING
San Antonio
Pinnacle Clinical Research
NOT_YET_RECRUITING
San Antonio
The Texas Liver Institute
NOT_YET_RECRUITING
San Antonio
Consano Clin Res-Shavano Park
NOT_YET_RECRUITING
Shavano Park
Texas Valley Clinical Research
NOT_YET_RECRUITING
Weslaco
Utah
Wee Care Pediatrics
NOT_YET_RECRUITING
Syracuse
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Nedlands
Queensland Children's Hospital
RECRUITING
South Brisbane
The Children's Hospital at Westmead - Clinical Research Centre
RECRUITING
Westmead
Austria
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
NOT_YET_RECRUITING
Innsbruck
Universitätsklinik für Kinder und Jugendheilkunde Haus E
NOT_YET_RECRUITING
Salzburg
Belgium
UZ Brussel - Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING
Brussels
UZA - UZ Antwerpen - Kinderziekenhuis
NOT_YET_RECRUITING
Edegem
Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
NOT_YET_RECRUITING
Plovdiv
Medical center Children's Health EOOD
NOT_YET_RECRUITING
Sofia
SHATPD - Prof. Ivan Mitev EAD
NOT_YET_RECRUITING
Sofia
UMHAT Sveta Marina EAD, First Pediatric Clinic
NOT_YET_RECRUITING
Varna
China
Beijing Children's Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Capital Center for Children's Health, Capital Medical University
NOT_YET_RECRUITING
Beijing
The First Bethune Hospital of Jilin University-Pediatric
NOT_YET_RECRUITING
Changchun
Chengdu Women's and Children's Central Hospital
NOT_YET_RECRUITING
Chengdu
Shandong Provincial Hospital-Pediatric
NOT_YET_RECRUITING
Jinan
Children's Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Children Hospital
NOT_YET_RECRUITING
Wuhan
Henan Children's Hospital Zhengzhou Children's Hospital
NOT_YET_RECRUITING
Zhengzhou
Colombia
Fundación Santa Fe de Bogotá
NOT_YET_RECRUITING
Bogotá
Servicios de Salud Ips Suramericana S.A.S.
NOT_YET_RECRUITING
Medellín
Croatia
Clinical Hospital Centre Rijeka_Pediatric
NOT_YET_RECRUITING
Rijeka
KBC Sestre Milosrdnice
NOT_YET_RECRUITING
Zagreb
Klinika Za Djecje Bolesti Zagreb_Endocrinology
NOT_YET_RECRUITING
Zagreb
Denmark
Aalborg Universitetshospital - Børne og Ungeafdelingen
NOT_YET_RECRUITING
Aalborg
Holbæk Sygehus - Børne- og Ungeafdelingen
NOT_YET_RECRUITING
Holbæk
Hungary
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem ÁOK
NOT_YET_RECRUITING
Budapest
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
NOT_YET_RECRUITING
Szeged
India
Indira Gandhi Institute of child health
NOT_YET_RECRUITING
Bangalore
Maulana Azad Medical College
NOT_YET_RECRUITING
Delhi
Endolife Specialty Hospitals
NOT_YET_RECRUITING
Guntur
Regency Hospital
NOT_YET_RECRUITING
Kanpur
Excel Endocrine Centre
NOT_YET_RECRUITING
Kolhāpur
Institute of Child Health
NOT_YET_RECRUITING
Kolkata
All India Institute of Medical Sciences (AIIMS)
NOT_YET_RECRUITING
New Delhi
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
BAPS Pramukh Swami Hospital
NOT_YET_RECRUITING
Surat
Israel
Rambam MC - Department of Pediatrics A
NOT_YET_RECRUITING
Haifa
Schneider MC - Endrocrinology and Diabetes
NOT_YET_RECRUITING
Petah Tikva
Shamir MC - Pediatric and Adolescents Endocrinology unit
NOT_YET_RECRUITING
Ẕerifin
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
NOT_YET_RECRUITING
Milan
AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
NOT_YET_RECRUITING
Novara
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
NOT_YET_RECRUITING
Trieste
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
NOT_YET_RECRUITING
Verona
Malaysia
Hospital Tunku Azizah
NOT_YET_RECRUITING
Kampung Baru
University Malaya Medical Centre
NOT_YET_RECRUITING
Lembah Pantai
Hospital Sibu
NOT_YET_RECRUITING
Sibu
Mexico
CHRISTUS - Latam Hub Excellence and Innovation Center
NOT_YET_RECRUITING
Monterrey
IECSI Centro de Investigación Clínica
NOT_YET_RECRUITING
Monterrey
Consultorio de Endocrinología y Pediatría
NOT_YET_RECRUITING
Puebla City
Netherlands
Jeroen Bosch Zkh
NOT_YET_RECRUITING
's-hertogenbosch
Meander MC
COMPLETED
Amersfoort
Poland
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
NOT_YET_RECRUITING
Dziekanów Leśny
Uniwersytecki Szpital Kliniczny w Opolu
NOT_YET_RECRUITING
Opole
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
NOT_YET_RECRUITING
Zabrze
Portugal
Hospital CUF Porto S.A.
NOT_YET_RECRUITING
Porto
ULS De Santo António, E.P.E. - Hospital de Santo António
NOT_YET_RECRUITING
Porto
ULS De Gaia/Espinho E.P.E. - Hospital Eduardo Santos Silva
NOT_YET_RECRUITING
Vila Nova De Gaia
Romania
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
NOT_YET_RECRUITING
Baia Mare
Kilostop Junior SRL
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic de Urgenta pentru Copii M.S.Curie
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
NOT_YET_RECRUITING
Timișoara
Serbia
Institute for Mother and Child Health Care of Serbia
NOT_YET_RECRUITING
Belgrade
University Children's Hospital Tirsova
NOT_YET_RECRUITING
Belgrade
Institute for Health Care of Children and Adolescents
NOT_YET_RECRUITING
Novi Sad
Slovakia
Narodny Ustav Detskych Chorob
NOT_YET_RECRUITING
Bratislava
Detska Fakultna nemocnica Kosice
NOT_YET_RECRUITING
Košice
Narodny Endokrinologicky a diabetologicky ustav
NOT_YET_RECRUITING
Ľubochňa
Spain
Hospital Vall d'Hebrón_Endocrinología pediatríca
NOT_YET_RECRUITING
Barcelona
Hospital Sant Joan de Déu
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Sweden
Barn och ungdomscentrum Västerbotten - NU
NOT_YET_RECRUITING
Umeå
Uppsala universitetssjukhus
NOT_YET_RECRUITING
Uppsala
Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
NOT_YET_RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
NOT_YET_RECRUITING
Taichung
Taipei Mackay Children's Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
NOT_YET_RECRUITING
Taoyuan District
Thailand
King Chulalongkorn Memorial Hospital_Ped-Nutrition
NOT_YET_RECRUITING
Bangkok
Thammasat Hospital_CRC
NOT_YET_RECRUITING
Pathum Thani
United Kingdom
Birmingham Children's Hospital
RECRUITING
Birmingham
Alder Hey Children's Hospital
RECRUITING
Liverpool
University College Hospital - Paediatric Services
RECRUITING
London
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-01-08
Estimated Completion Date: 2033-09-20
Participants
Target number of participants: 460
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov