En forskningsstudie om hvor godt Cagrilintide og CagriSema virker hos barn og ungdom med overvekt
28. september 2026 oppdatert av: Novo Nordisk A/S
Effekt, sikkerhet og farmakokinetikk for Cagrilintide s.c. 2,4 mg som monoterapi og i kombinasjon med Semaglutide s.c. 2,4 mg (CagriSema) en gang i uken for vekthåndtering hos barn og ungdom med overvekt eller fedme
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.
Studieoversikt
Status
Status
Rekruttering
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Intervensjonell
Registrering (Antatt)
Registrering
460
Fase
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Rekruttering
- The Children's Hospital at Westmead - Clinical Research Centre
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Rekruttering
- Queensland Children's Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Rekruttering
- Perth Children's Hospital
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Brussels, Belgia, 1090
- Rekruttering
- UZ Brussel - Universitair Ziekenhuis Brussel
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Edegem, Belgia, 2650
- Rekruttering
- UZA - Universitair Ziekenhuis Antwerpen
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Plovdiv, Bulgaria, 4001
- Rekruttering
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
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Sofia, Bulgaria, 1618
- Har ikke rekruttert ennå
- Medical center Children's Health EOOD
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Sofia, Bulgaria, 1606
- Rekruttering
- SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
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Varna, Bulgaria, 9010
- Rekruttering
- UMHAT Sveta Marina EAD, First Pediatric Clinic
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Bogotá, Colombia, 110111
- Har ikke rekruttert ennå
- Fundación Santa Fe de Bogotá
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Antioquia
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Medellín, Antioquia, Colombia, 05001
- Har ikke rekruttert ennå
- Servicios de Salud Ips Suramericana S.A.S.
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Aalborg, Danmark, 9000
- Har ikke rekruttert ennå
- Aalborg Universitetshospital - Børne og Ungeafdelingen
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Holbæk, Danmark, 4300
- Rekruttering
- Holbæk Sygehus - Børne- og Ungeafdelingen
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California
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Escondido, California, Forente stater, 92025
- Rekruttering
- Neighborhood Healthcare
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Florida
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Hollywood, Florida, Forente stater, 33024
- Rekruttering
- Encore Medical Research LLC
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Jacksonville, Florida, Forente stater, 32216
- Rekruttering
- Jacksonville Ctr for Clin Res
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Weston, Florida, Forente stater, 33331
- Rekruttering
- Encore Medical Research of Weston
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Georgia
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Atlanta, Georgia, Forente stater, 30329
- Rekruttering
- Children's Healthcare Atlanta
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Columbus, Georgia, Forente stater, 31904
- Rekruttering
- Columbus Research Foundation
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Decatur, Georgia, Forente stater, 30030
- Rekruttering
- Accel Research Sites-NeuroStudies
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Snellville, Georgia, Forente stater, 30078
- Rekruttering
- Eastside Bariatric and Gen Surg
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Idaho
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Meridian, Idaho, Forente stater, 83646
- Rekruttering
- Solaris Clinical Research
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Rekruttering
- IU Health - Riley Physicians Endo-Diab
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Kansas
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Topeka, Kansas, Forente stater, 66606
- Rekruttering
- Cotton O'Neil Clinical Research Center
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808-4124
- Rekruttering
- Pennington Biomed Res Ctr
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Maryland
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Baltimore, Maryland, Forente stater, 21229
- Rekruttering
- Barry J. Reiner, MD LLC
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Rekruttering
- University of Minnesota
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Richfield, Minnesota, Forente stater, 55423
- Rekruttering
- Synexus Clinical Research US-MN
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New York
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Buffalo, New York, Forente stater, 14203
- Har ikke rekruttert ennå
- UBMD Physicians Group - Pediatrics - Conventus
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Syracuse, New York, Forente stater, 13210
- Rekruttering
- SUNY Upstate Medical Univ - Syracuse
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The Bronx, New York, Forente stater, 10467
- Har ikke rekruttert ennå
- Advantage Clinical Trials
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North Dakota
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Fargo, North Dakota, Forente stater, 58104
- Rekruttering
- Valley Weight Loss Clinic
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Ohio
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Columbus, Ohio, Forente stater, 43213
- Rekruttering
- Centricity Research - Ohio
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Dayton, Ohio, Forente stater, 45429
- Rekruttering
- PriMed Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Har ikke rekruttert ennå
- Children's Physicians OU
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15224
- Har ikke rekruttert ennå
- UPMC Child Hosp-Pittsburgh
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Har ikke rekruttert ennå
- Prisma Health-Ped Endo
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North Charleston, South Carolina, Forente stater, 29405
- Rekruttering
- Coastal Carolina Research Ctr
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Har ikke rekruttert ennå
- Monument Health Clinical Rsrch
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Tennessee
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Memphis, Tennessee, Forente stater, 38115
- Rekruttering
- LifeDoc Health
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Texas
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Houston, Texas, Forente stater, 77065
- Rekruttering
- DM Clinical
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San Antonio, Texas, Forente stater, 78215
- Rekruttering
- The Texas Liver Institute
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San Antonio, Texas, Forente stater, 78207
- Har ikke rekruttert ennå
- DM Clinical
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San Antonio, Texas, Forente stater, 78222
- Rekruttering
- Pinnacle Clinical Research
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Shavano Park, Texas, Forente stater, 78231
- Rekruttering
- Consano Clin Res-Shavano Park
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Weslaco, Texas, Forente stater, 78596
- Rekruttering
- Texas Valley Clinical Research
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Utah
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Layton, Utah, Forente stater, 84041
- Rekruttering
- AMR Clinical
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Kolhāpur, India, 416008
- Har ikke rekruttert ennå
- Excel Endocrine Centre
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New Delhi, India, 110029
- Har ikke rekruttert ennå
- All India Institute of Medical Sciences (AIIMS)
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
- Har ikke rekruttert ennå
- Endolife Specialty Hospitals
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Gujarat
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Surat, Gujarat, India, 395009
- Har ikke rekruttert ennå
- BAPS Pramukh Swami Hospital
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Karnataka
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Bangalore, Karnataka, India, 560011
- Har ikke rekruttert ennå
- Indira Gandhi Institute of child health
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110060
- Har ikke rekruttert ennå
- Sir Ganga Ram Hospital
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New Delhi
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Delhi, New Delhi, India, 110002
- Har ikke rekruttert ennå
- Maulana Azad Medical College
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Uttar Pradesh
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Kanpur, Uttar Pradesh, India, 208006
- Har ikke rekruttert ennå
- Regency Hospital
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West Bengal
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Kolkata, West Bengal, India, 700017
- Har ikke rekruttert ennå
- Institute of Child Health
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Haifa, Israel, 31096
- Har ikke rekruttert ennå
- Rambam MC - Department of Pediatrics A
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Jerusalem, Israel, 9103102
- Har ikke rekruttert ennå
- Shaare Zedek MC - Endocrinology Department
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Petah Tikva, Israel, 49202
- Har ikke rekruttert ennå
- Schneider MC - Endrocrinology and Diabetes
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Tsrifin, Israel, 7033001
- Har ikke rekruttert ennå
- Shamir MC - Pediatric and Adolescents Endocrinology unit
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Trieste, Italia, 34137
- Har ikke rekruttert ennå
- IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
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Lombardy
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Milan, Lombardy, Italia, 20122
- Har ikke rekruttert ennå
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
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Piedmont
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Novara, Piedmont, Italia, 28100
- Har ikke rekruttert ennå
- AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
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Veneto
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Verona, Veneto, Italia, 37126
- Har ikke rekruttert ennå
- A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100045
- Har ikke rekruttert ennå
- Beijing Children's Hospital, Capital Medical University
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Beijing, Beijing Municipality, Kina, 100020
- Rekruttering
- Capital Center for Children's Health, Capital Medical University-Endocrinology
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Henan
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Zhengzhou, Henan, Kina, 450018
- Rekruttering
- Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
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Hubei
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Wuhan, Hubei, Kina, 430019
- Rekruttering
- Wuhan Children Hospital-Endocrine Genetics and Metabolism
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Wuhan, Hubei, Kina, 430030
- Rekruttering
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
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Jilin
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Changchun, Jilin, Kina, 130021
- Har ikke rekruttert ennå
- The First Bethune Hospital of Jilin University-Pediatric
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Shandong
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Jinan, Shandong, Kina, 250098
- Rekruttering
- Shandong Provincial Hospital-Pediatric
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 201102
- Rekruttering
- Children's Hospital of Fudan University-Endocrinology and Metabolism
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Sichuan
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Chengdu, Sichuan, Kina, 610031
- Rekruttering
- Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
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Rijeka, Kroatia, 51 000
- Har ikke rekruttert ennå
- Clinical Hospital Centre Rijeka_Pediatric
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Zagreb, Kroatia, 10 000
- Har ikke rekruttert ennå
- KBC "Sestre Milosrdnice"
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Zagreb, Kroatia, 10000
- Har ikke rekruttert ennå
- Klinika Za Djecje Bolesti Zagreb_Endocrinology
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Kuala Lumpur
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Kampung Baru, Kuala Lumpur, Malaysia, 50300
- Har ikke rekruttert ennå
- Hospital Tunku Azizah
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Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Sarawak
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Sibu, Sarawak, Malaysia, 96000
- Rekruttering
- Hospital Sibu
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Puebla City, Mexico, 72190
- Har ikke rekruttert ennå
- Consultorio de Endocrinología y Pediatría
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64060
- Har ikke rekruttert ennå
- CHRISTUS - Latam Hub Excellence and Innovation Center
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Monterrey, Nuevo León, Mexico, 64310
- Har ikke rekruttert ennå
- IECSI Centro de Investigación Clínica
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's-Hertogenbosch, Nederland, 5223 GZ
- Har ikke rekruttert ennå
- Jeroen Bosch Zkh
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Amersfoort, Nederland, 3813 TZ
- Fullført
- Meander MC
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Dziekanów Leśny, Polen, 05-092
- Har ikke rekruttert ennå
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
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Opole, Polen, 45-401
- Har ikke rekruttert ennå
- Uniwersytecki Szpital Kliniczny w Opolu
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Rzeszów, Polen, 35-301
- Har ikke rekruttert ennå
- Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
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Zabrze, Polen, 41-800
- Har ikke rekruttert ennå
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
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Porto, Portugal, 4050-651
- Har ikke rekruttert ennå
- ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
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Porto, Portugal, 4100-180
- Har ikke rekruttert ennå
- CUF Porto_Serviço de Pediatria
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Vila Nova de Gaia, Portugal, 4434-502
- Har ikke rekruttert ennå
- ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
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Baia Mare, Romania, 430031
- Har ikke rekruttert ennå
- Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
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Bucharest, Romania, 041451
- Rekruttering
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
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Bucharest, Romania, 010073
- Rekruttering
- Kilostop Junior SRL
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Timișoara, Romania, 300226
- Rekruttering
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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Belgrade, Serbia, 11000
- Rekruttering
- University Children's Hospital Tirsova
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Belgrade, Serbia, 11070
- Rekruttering
- Institute for Mother and Child Health Care of Serbia
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Novi Sad, Serbia, 21000
- Rekruttering
- Institute for Health Care of Children and Adolescents
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Bratislava, Slovakia, 833 40
- Har ikke rekruttert ennå
- Narodny Ustav Detskych Chorob
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Košice, Slovakia, 040 01
- Rekruttering
- Detska Fakultna nemocnica Kosice
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Poprad, Slovakia, 058 45
- Har ikke rekruttert ennå
- Nemocnica Poprad, a.s.
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Ľubochňa, Slovakia, 03491
- Rekruttering
- Narodny Endokrinologicky a diabetologicky ustav
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Barcelona, Spania, 08035
- Har ikke rekruttert ennå
- Hosp. Vall d'Hebrón_Endocrinología pediatríca
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Esplugues de Llobregat, Spania, 08950
- Har ikke rekruttert ennå
- Hospital Sant Joan de Déu
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Seville, Spania, 41013
- Har ikke rekruttert ennå
- Hospital Universitario Virgen del Rocío
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Birmingham, Storbritannia, B4 6NH
- Rekruttering
- Birmingham Children's Hospital
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Liverpool, Storbritannia, L12 2AP
- Rekruttering
- Alder Hey Children's Hospital
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London, Storbritannia, NW1 1BU
- Rekruttering
- University College Hospital - Paediatric Services
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-
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Umeå, Sverige, 907 37
- Har ikke rekruttert ennå
- Barn och ungdomscentrum Västerbotten - NU
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Uppsala, Sverige, 75185
- Har ikke rekruttert ennå
- Akademiska barnsjukhuset - klinisk forskningsmottagning
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-
-
-
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Kaohsiung City, Taiwan, 833
- Rekruttering
- Chang Gung Memorial Hospital - Kaohsiung Branch
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Taichung, Taiwan, 402
- Rekruttering
- Chung Shan Medical University Hospital
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Taipei, Taiwan, 104
- Rekruttering
- Taipei Mackay Children's Hospital
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Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
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-
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-
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Bangkok, Thailand, 10300
- Rekruttering
- King Chulalongkorn Memorial Hospital_Ped-Nutrition
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Pathum Thani, Thailand, 12120
- Rekruttering
- Thammasat Hospital_CRC
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-
-
-
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Budapest, Ungarn, 1083
- Har ikke rekruttert ennå
- Semmelweis Egyetem ÁOK
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Budapest, Ungarn, 1023
- Rekruttering
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
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Szeged, Ungarn, 6720
- Har ikke rekruttert ennå
- Szegedi Tudományegyetem Gyermekgyógyászati Klinika
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Innsbruck, Østerrike, 6020
- Rekruttering
- Universitätsklinik Kinder-Jugendheilkunde Innsbruck
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Salzburg, Østerrike, 5020
- Rekruttering
- Universitätsklinik für Kinder und Jugendheilkunde Haus E
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Antall våpen
4
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Participants will receive cagrilintide subcutaneously. Participants will receive semaglutide subcutaneously. Participants will receive placebo matched to cagrilintide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
|
Eksperimentell: 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. |
Participants will receive semaglutide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
|
Eksperimentell: 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. |
Participants will receive cagrilintide subcutaneously. Participants will receive placebo matched to cagrilintide subcutaneously. |
|
Placebo komparator: 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. |
Participants will receive placebo matched to cagrilintide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relative change in body mass index (BMI)
Tidsramme: Baseline (week 0), week 68
|
Measured in percentage (%). |
Baseline (week 0), week 68
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relative change in body weight
Tidsramme: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Change in BMI Standard Deviation Score (SDS)
Tidsramme: Baseline (week 0), week 68
|
Measured as SDS score. |
Baseline (week 0), week 68
|
|
Relative change in BMI
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in %. |
Baseline (week 0), week 68 and week 224
|
|
Number of participants in weight category reduction
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=10% reduction of body weight (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=15% reduction of body weight (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=20% reduction of body weight (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=25% reduction of body weight (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=5% reduction of BMI (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=10% reduction of BMI (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=15% reduction of BMI (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=20% reduction of BMI (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved >=25% reduction of BMI (yes/no)
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved normal BMI
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who shifted from obese to non-obese BMI class
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Change in waist circumference
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in centimeter (cm). |
Baseline (week 0), week 68 and week 224
|
|
Change in waist-to-height ratio
Tidsramme: Baseline (week 0), week 68
|
Measured as ratio. |
Baseline (week 0), week 68
|
|
Absolute change in total fat mass by dual energy X-ray absorption (DXA)
Tidsramme: Baseline (week 0), week 68
|
Measured in kilograms (kg). |
Baseline (week 0), week 68
|
|
Relative to baseline change in total fat mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in total fat mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in visceral fat mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in kg. |
Baseline (week 0), week 68
|
|
Relative to baseline change in visceral fat mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in visceral fat mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in lean body mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in kg. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in lean body mass by DXA
Tidsramme: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in liters (L). |
Baseline (week 0), week 68 and week 224
|
|
Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in %. |
Baseline (week 0), week 68 and week 224
|
|
Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in % points. |
Baseline (week 0), week 68 and week 224
|
|
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in liters. |
Baseline (week 0), week 68 and week 224
|
|
Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in %. |
Baseline (week 0), week 68 and week 224
|
|
Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in liters. |
Baseline (week 0), week 68 and week 224
|
|
Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in %. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in BMI percentage of the 95th percentile
Tidsramme: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Tidsramme: Baseline (week 0), week 68
|
Measured as ratio. |
Baseline (week 0), week 68
|
|
Ratio to baseline in lipids: Total cholesterol
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in lipids: Triglycerides
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in lipids: Non-HDL cholesterol
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in Alanine Transaminase (ALT)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in Units per Liter (U/L). |
Baseline (week 0), week 68 and week 224
|
|
Change in systolic blood pressure
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in millimeters of mercury (mmHg). |
Baseline (week 0), week 68 and week 224
|
|
Change in diastolic blood pressure
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in mmHg. |
Baseline (week 0), week 68 and week 224
|
|
Ratio to baseline in liver stiffness measured by ultrasonographic methods
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in glycated haemoglobin (HbA1c) (% points)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in % points. |
Baseline (week 0), week 68 and week 224
|
|
Change in HbA1c (millimoles per mole [mmol/mol])
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured in mmol/mol. |
Baseline (week 0), week 68 and week 224
|
|
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Tidsramme: Baseline (week 0), week 68
|
Measured in mmol/L. |
Baseline (week 0), week 68
|
|
Change in FPG (milligrams per deciliter [mg/dL])
Tidsramme: Baseline (week 0), week 68
|
Measured in mg/dL. |
Baseline (week 0), week 68
|
|
Ratio to baseline in fasting serum insulin
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline
Tidsramme: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 %
Tidsramme: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5%
Tidsramme: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%
Tidsramme: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants taking glucose lowering medication at baseline, stop or decrease
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants taking antihypertensive medication at baseline, stop or decrease
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants taking lipid lowering medication at baseline, stop or decrease
Tidsramme: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). |
Baseline (week 0), week 68 and week 224
|
|
IWQOL Kids - Body esteem domain score
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). |
Baseline (week 0), week 68 and week 224
|
|
IWQOL Kids - Social life domain score
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). |
Baseline (week 0), week 68 and week 224
|
|
IWQOL Kids - Family-relations score
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). |
Baseline (week 0), week 68 and week 224
|
|
IWQOL Kids - Total score
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100). |
Baseline (week 0), week 68 and week 224
|
|
Control of Eating Questionnaire (COEQ)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control. |
Baseline (week 0), week 68 and week 224
|
|
Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as counts. |
Baseline (week 0), week 68 and week 224
|
|
Number of treatment-emergent adverse events (TEAEs)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as count of events. |
Baseline (week 0), week 68 and week 224
|
|
Number of treatment-emergent serious adverse events (TESAEs)
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as count of events. |
Baseline (week 0), week 68 and week 224
|
|
Number of treatment-emergent hypoglycaemic episodes
Tidsramme: Baseline (week 0), week 68 and week 224
|
Measured as count of events. |
Baseline (week 0), week 68 and week 224
|
|
Change in pulse rate
Tidsramme: Baseline (week 0), week 68
|
Measured in beats per minute (beats/min). |
Baseline (week 0), week 68
|
|
Change in calcitonin
Tidsramme: Baseline (week 0), week 68
|
Measured in nanograms per liter (ng/L). |
Baseline (week 0), week 68
|
|
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state
Tidsramme: Baseline (week 0), week 68
|
Measured in liters per hour (L/h). |
Baseline (week 0), week 68
|
|
Average concentration (Cavg) of semaglutide and cagrilintide at steady state
Tidsramme: Baseline (week 0), week 68
|
Measured in nanomoles per liter (nmol/L). |
Baseline (week 0), week 68
|
|
Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide
Tidsramme: Baseline (week 0), week 68
|
Measured in hours nanomoles per liter (h·nmol/L). |
Baseline (week 0), week 68
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Sponsor
Etterforskere
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
8. januar 2026
Primær fullføring (Antatt)
Primær fullføring
20. mars 2030
Studiet fullført (Antatt)
Studiet fullført
20. september 2033
Datoer for studieregistrering
Først innsendt
Først innsendt
19. november 2025
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
19. november 2025
Først lagt ut (Faktiske)
Først lagt ut
28. november 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
30. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. september 2026
Sist bekreftet
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- NN9838-4968
- U1111-1299-4751 (Annen identifikator: World Health Organization (WHO))
- 2023-509176-42 (Annen identifikator: European Medical Agency (EMA))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .