Badanie naukowe dotyczące skuteczności działania Cagrilintide i CagriSema u dzieci i młodzieży z nadmierną masą ciała
28 września 2026 zaktualizowane przez: Novo Nordisk A/S
Skuteczność, bezpieczeństwo i farmakokinetyka podskórnego kagrilintydu 2,4 mg w monoterapii oraz w skojarzeniu z podskórnym semaglutydem 2,4 mg (CagriSema) podawanego raz w tygodniu w celu kontroli masy ciała u dzieci i młodzieży z nadwagą lub otyłością
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.
Przegląd badań
Status
Status
Rekrutacyjny
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
460
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Novo Nordisk
- Numer telefonu: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Lokalizacje studiów
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Rekrutacyjny
- The Children's Hospital at Westmead - Clinical Research Centre
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Rekrutacyjny
- Queensland Children's Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Rekrutacyjny
- Perth Children's Hospital
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Innsbruck, Austria, 6020
- Rekrutacyjny
- Universitätsklinik Kinder-Jugendheilkunde Innsbruck
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Salzburg, Austria, 5020
- Rekrutacyjny
- Universitätsklinik für Kinder und Jugendheilkunde Haus E
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Brussels, Belgia, 1090
- Rekrutacyjny
- UZ Brussel - Universitair Ziekenhuis Brussel
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Edegem, Belgia, 2650
- Rekrutacyjny
- UZA - Universitair Ziekenhuis Antwerpen
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Plovdiv, Bułgaria, 4001
- Rekrutacyjny
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
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Sofia, Bułgaria, 1618
- Jeszcze nie rekrutacja
- Medical center Children's Health EOOD
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Sofia, Bułgaria, 1606
- Rekrutacyjny
- SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
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Varna, Bułgaria, 9010
- Rekrutacyjny
- UMHAT Sveta Marina EAD, First Pediatric Clinic
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100045
- Jeszcze nie rekrutacja
- Beijing Children's Hospital, Capital Medical University
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Beijing, Beijing Municipality, Chiny, 100020
- Rekrutacyjny
- Capital Center for Children's Health, Capital Medical University-Endocrinology
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Henan
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Zhengzhou, Henan, Chiny, 450018
- Rekrutacyjny
- Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
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Hubei
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Wuhan, Hubei, Chiny, 430019
- Rekrutacyjny
- Wuhan Children Hospital-Endocrine Genetics and Metabolism
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Wuhan, Hubei, Chiny, 430030
- Rekrutacyjny
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
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Jilin
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Changchun, Jilin, Chiny, 130021
- Jeszcze nie rekrutacja
- The First Bethune Hospital of Jilin University-Pediatric
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Shandong
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Jinan, Shandong, Chiny, 250098
- Rekrutacyjny
- Shandong Provincial Hospital-Pediatric
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 201102
- Rekrutacyjny
- Children's Hospital of Fudan University-Endocrinology and Metabolism
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Sichuan
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Chengdu, Sichuan, Chiny, 610031
- Rekrutacyjny
- Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
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Rijeka, Chorwacja, 51 000
- Jeszcze nie rekrutacja
- Clinical Hospital Centre Rijeka_Pediatric
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Zagreb, Chorwacja, 10 000
- Jeszcze nie rekrutacja
- KBC "Sestre Milosrdnice"
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Zagreb, Chorwacja, 10000
- Jeszcze nie rekrutacja
- Klinika Za Djecje Bolesti Zagreb_Endocrinology
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Aalborg, Dania, 9000
- Jeszcze nie rekrutacja
- Aalborg Universitetshospital - Børne og Ungeafdelingen
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Holbæk, Dania, 4300
- Rekrutacyjny
- Holbæk Sygehus - Børne- og Ungeafdelingen
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Barcelona, Hiszpania, 08035
- Jeszcze nie rekrutacja
- Hosp. Vall d'Hebrón_Endocrinología pediatríca
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Esplugues de Llobregat, Hiszpania, 08950
- Jeszcze nie rekrutacja
- Hospital Sant Joan de Déu
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Seville, Hiszpania, 41013
- Jeszcze nie rekrutacja
- Hospital Universitario Virgen del Rocío
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's-Hertogenbosch, Holandia, 5223 GZ
- Jeszcze nie rekrutacja
- Jeroen Bosch Zkh
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Amersfoort, Holandia, 3813 TZ
- Zakończony
- Meander MC
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Kolhāpur, Indie, 416008
- Jeszcze nie rekrutacja
- Excel Endocrine Centre
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New Delhi, Indie, 110029
- Jeszcze nie rekrutacja
- All India Institute of Medical Sciences (AIIMS)
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indie, 522001
- Jeszcze nie rekrutacja
- Endolife Specialty Hospitals
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Gujarat
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Surat, Gujarat, Indie, 395009
- Jeszcze nie rekrutacja
- BAPS Pramukh Swami Hospital
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Karnataka
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Bangalore, Karnataka, Indie, 560011
- Jeszcze nie rekrutacja
- 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, Indie, 110060
- Jeszcze nie rekrutacja
- Sir Ganga Ram Hospital
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New Delhi
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Delhi, New Delhi, Indie, 110002
- Jeszcze nie rekrutacja
- Maulana Azad Medical College
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Uttar Pradesh
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Kanpur, Uttar Pradesh, Indie, 208006
- Jeszcze nie rekrutacja
- Regency Hospital
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West Bengal
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Kolkata, West Bengal, Indie, 700017
- Jeszcze nie rekrutacja
- Institute of Child Health
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Haifa, Izrael, 31096
- Jeszcze nie rekrutacja
- Rambam MC - Department of Pediatrics A
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Jerusalem, Izrael, 9103102
- Jeszcze nie rekrutacja
- Shaare Zedek MC - Endocrinology Department
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Petah Tikva, Izrael, 49202
- Jeszcze nie rekrutacja
- Schneider MC - Endrocrinology and Diabetes
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Tsrifin, Izrael, 7033001
- Jeszcze nie rekrutacja
- Shamir MC - Pediatric and Adolescents Endocrinology unit
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Bogotá, Kolumbia, 110111
- Jeszcze nie rekrutacja
- Fundación Santa Fe de Bogotá
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Antioquia
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Medellín, Antioquia, Kolumbia, 05001
- Jeszcze nie rekrutacja
- Servicios de Salud Ips Suramericana S.A.S.
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Kuala Lumpur
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Kampung Baru, Kuala Lumpur, Malezja, 50300
- Jeszcze nie rekrutacja
- Hospital Tunku Azizah
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Lembah Pantai, Kuala Lumpur, Malezja, 59100
- Rekrutacyjny
- University Malaya Medical Centre
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Sarawak
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Sibu, Sarawak, Malezja, 96000
- Rekrutacyjny
- Hospital Sibu
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Puebla City, Meksyk, 72190
- Jeszcze nie rekrutacja
- Consultorio de Endocrinología y Pediatría
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Nuevo León
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Monterrey, Nuevo León, Meksyk, 64060
- Jeszcze nie rekrutacja
- CHRISTUS - Latam Hub Excellence and Innovation Center
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Monterrey, Nuevo León, Meksyk, 64310
- Jeszcze nie rekrutacja
- IECSI Centro de Investigación Clínica
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Dziekanów Leśny, Polska, 05-092
- Jeszcze nie rekrutacja
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
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Opole, Polska, 45-401
- Jeszcze nie rekrutacja
- Uniwersytecki Szpital Kliniczny w Opolu
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Rzeszów, Polska, 35-301
- Jeszcze nie rekrutacja
- Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
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Zabrze, Polska, 41-800
- Jeszcze nie rekrutacja
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
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Porto, Portugalia, 4050-651
- Jeszcze nie rekrutacja
- ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
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Porto, Portugalia, 4100-180
- Jeszcze nie rekrutacja
- CUF Porto_Serviço de Pediatria
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Vila Nova de Gaia, Portugalia, 4434-502
- Jeszcze nie rekrutacja
- ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
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Baia Mare, Rumunia, 430031
- Jeszcze nie rekrutacja
- Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
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Bucharest, Rumunia, 041451
- Rekrutacyjny
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
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Bucharest, Rumunia, 010073
- Rekrutacyjny
- Kilostop Junior SRL
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Timișoara, Rumunia, 300226
- Rekrutacyjny
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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Belgrade, Serbia, 11000
- Rekrutacyjny
- University Children's Hospital Tirsova
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Belgrade, Serbia, 11070
- Rekrutacyjny
- Institute for Mother and Child Health Care of Serbia
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Novi Sad, Serbia, 21000
- Rekrutacyjny
- Institute for Health Care of Children and Adolescents
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California
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Escondido, California, Stany Zjednoczone, 92025
- Rekrutacyjny
- Neighborhood Healthcare
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Florida
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Hollywood, Florida, Stany Zjednoczone, 33024
- Rekrutacyjny
- Encore Medical Research LLC
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Jacksonville, Florida, Stany Zjednoczone, 32216
- Rekrutacyjny
- Jacksonville Ctr for Clin Res
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Weston, Florida, Stany Zjednoczone, 33331
- Rekrutacyjny
- Encore Medical Research of Weston
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30329
- Rekrutacyjny
- Children's Healthcare Atlanta
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Columbus, Georgia, Stany Zjednoczone, 31904
- Rekrutacyjny
- Columbus Research Foundation
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Decatur, Georgia, Stany Zjednoczone, 30030
- Rekrutacyjny
- Accel Research Sites-NeuroStudies
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Snellville, Georgia, Stany Zjednoczone, 30078
- Rekrutacyjny
- Eastside Bariatric and Gen Surg
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Idaho
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Meridian, Idaho, Stany Zjednoczone, 83646
- Rekrutacyjny
- Solaris Clinical Research
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Rekrutacyjny
- IU Health - Riley Physicians Endo-Diab
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Kansas
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Topeka, Kansas, Stany Zjednoczone, 66606
- Rekrutacyjny
- Cotton O'Neil Clinical Research Center
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808-4124
- Rekrutacyjny
- Pennington Biomed Res Ctr
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21229
- Rekrutacyjny
- Barry J. Reiner, MD LLC
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Rekrutacyjny
- University of Minnesota
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Richfield, Minnesota, Stany Zjednoczone, 55423
- Rekrutacyjny
- Synexus Clinical Research US-MN
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New York
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Buffalo, New York, Stany Zjednoczone, 14203
- Jeszcze nie rekrutacja
- UBMD Physicians Group - Pediatrics - Conventus
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Syracuse, New York, Stany Zjednoczone, 13210
- Rekrutacyjny
- SUNY Upstate Medical Univ - Syracuse
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The Bronx, New York, Stany Zjednoczone, 10467
- Jeszcze nie rekrutacja
- Advantage Clinical Trials
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58104
- Rekrutacyjny
- Valley Weight Loss Clinic
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Ohio
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Columbus, Ohio, Stany Zjednoczone, 43213
- Rekrutacyjny
- Centricity Research - Ohio
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Dayton, Ohio, Stany Zjednoczone, 45429
- Rekrutacyjny
- PriMed Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- Jeszcze nie rekrutacja
- Children's Physicians OU
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- Jeszcze nie rekrutacja
- UPMC Child Hosp-Pittsburgh
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29615
- Jeszcze nie rekrutacja
- Prisma Health-Ped Endo
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North Charleston, South Carolina, Stany Zjednoczone, 29405
- Rekrutacyjny
- Coastal Carolina Research Ctr
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South Dakota
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Rapid City, South Dakota, Stany Zjednoczone, 57701
- Jeszcze nie rekrutacja
- Monument Health Clinical Rsrch
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38115
- Rekrutacyjny
- LifeDoc Health
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Texas
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Houston, Texas, Stany Zjednoczone, 77065
- Rekrutacyjny
- DM Clinical
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San Antonio, Texas, Stany Zjednoczone, 78215
- Rekrutacyjny
- The Texas Liver Institute
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San Antonio, Texas, Stany Zjednoczone, 78207
- Jeszcze nie rekrutacja
- DM Clinical
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San Antonio, Texas, Stany Zjednoczone, 78222
- Rekrutacyjny
- Pinnacle Clinical Research
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Shavano Park, Texas, Stany Zjednoczone, 78231
- Rekrutacyjny
- Consano Clin Res-Shavano Park
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Weslaco, Texas, Stany Zjednoczone, 78596
- Rekrutacyjny
- Texas Valley Clinical Research
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Utah
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Layton, Utah, Stany Zjednoczone, 84041
- Rekrutacyjny
- AMR Clinical
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Umeå, Szwecja, 907 37
- Jeszcze nie rekrutacja
- Barn och ungdomscentrum Västerbotten - NU
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Uppsala, Szwecja, 75185
- Jeszcze nie rekrutacja
- Akademiska barnsjukhuset - klinisk forskningsmottagning
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Bratislava, Słowacja, 833 40
- Jeszcze nie rekrutacja
- Narodny Ustav Detskych Chorob
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Košice, Słowacja, 040 01
- Rekrutacyjny
- Detska Fakultna nemocnica Kosice
-
Poprad, Słowacja, 058 45
- Jeszcze nie rekrutacja
- Nemocnica Poprad, a.s.
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Ľubochňa, Słowacja, 03491
- Rekrutacyjny
- Narodny Endokrinologicky a diabetologicky ustav
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Bangkok, Tajlandia, 10300
- Rekrutacyjny
- King Chulalongkorn Memorial Hospital_Ped-Nutrition
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Pathum Thani, Tajlandia, 12120
- Rekrutacyjny
- Thammasat Hospital_CRC
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Kaohsiung City, Tajwan, 833
- Rekrutacyjny
- Chang Gung Memorial Hospital - Kaohsiung Branch
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Taichung, Tajwan, 402
- Rekrutacyjny
- Chung Shan Medical University Hospital
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Taipei, Tajwan, 104
- Rekrutacyjny
- Taipei Mackay Children's Hospital
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Taoyuan, Tajwan, 333
- Rekrutacyjny
- Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
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Budapest, Węgry, 1083
- Jeszcze nie rekrutacja
- Semmelweis Egyetem ÁOK
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Budapest, Węgry, 1023
- Rekrutacyjny
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
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Szeged, Węgry, 6720
- Jeszcze nie rekrutacja
- Szegedi Tudományegyetem Gyermekgyógyászati Klinika
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Trieste, Włochy, 34137
- Jeszcze nie rekrutacja
- IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
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Lombardy
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Milan, Lombardy, Włochy, 20122
- Jeszcze nie rekrutacja
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
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Piedmont
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Novara, Piedmont, Włochy, 28100
- Jeszcze nie rekrutacja
- AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
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Veneto
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Verona, Veneto, Włochy, 37126
- Jeszcze nie rekrutacja
- A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
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Birmingham, Zjednoczone Królestwo, B4 6NH
- Rekrutacyjny
- Birmingham Children's Hospital
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Liverpool, Zjednoczone Królestwo, L12 2AP
- Rekrutacyjny
- Alder Hey Children's Hospital
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London, Zjednoczone Królestwo, NW1 1BU
- Rekrutacyjny
- University College Hospital - Paediatric Services
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
8 lat do 18 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
4
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
|
Komparator placebo: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relative change in body mass index (BMI)
Ramy czasowe: Baseline (week 0), week 68
|
Measured in percentage (%). |
Baseline (week 0), week 68
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relative change in body weight
Ramy czasowe: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Change in BMI Standard Deviation Score (SDS)
Ramy czasowe: Baseline (week 0), week 68
|
Measured as SDS score. |
Baseline (week 0), week 68
|
|
Relative change in BMI
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved normal BMI
Ramy czasowe: 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
Ramy czasowe: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Change in waist circumference
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: Baseline (week 0), week 68
|
Measured in kilograms (kg). |
Baseline (week 0), week 68
|
|
Relative to baseline change in total fat mass by DXA
Ramy czasowe: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in total fat mass by DXA
Ramy czasowe: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in visceral fat mass by DXA
Ramy czasowe: Baseline (week 0), week 68
|
Measured in kg. |
Baseline (week 0), week 68
|
|
Relative to baseline change in visceral fat mass by DXA
Ramy czasowe: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in visceral fat mass by DXA
Ramy czasowe: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in lean body mass by DXA
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Ramy czasowe: Baseline (week 0), week 68
|
Measured as ratio. |
Baseline (week 0), week 68
|
|
Ratio to baseline in lipids: Total cholesterol
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in Alanine Transaminase (ALT)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: Baseline (week 0), week 68
|
Measured in mmol/L. |
Baseline (week 0), week 68
|
|
Change in FPG (milligrams per deciliter [mg/dL])
Ramy czasowe: Baseline (week 0), week 68
|
Measured in mg/dL. |
Baseline (week 0), week 68
|
|
Ratio to baseline in fasting serum insulin
Ramy czasowe: 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
Ramy czasowe: 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 %
Ramy czasowe: 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%
Ramy czasowe: 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%
Ramy czasowe: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants taking glucose lowering medication at baseline, stop or decrease
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (week 0), week 68
|
Measured in beats per minute (beats/min). |
Baseline (week 0), week 68
|
|
Change in calcitonin
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (week 0), week 68
|
Measured in hours nanomoles per liter (h·nmol/L). |
Baseline (week 0), week 68
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
8 stycznia 2026
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
20 marca 2030
Ukończenie studiów (Szacowany)
Ukończenie studiów
20 września 2033
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
19 listopada 2025
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 listopada 2025
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
28 listopada 2025
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
30 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 września 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NN9838-4968
- U1111-1299-4751 (Inny identyfikator: World Health Organization (WHO))
- 2023-509176-42 (Inny identyfikator: European Medical Agency (EMA))
- 2023 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .