Um Estudo de Investigação sobre a Eficácia do Cagrilintida e do CagriSema em Crianças e Adolescentes com Excesso de Peso Corporal
Eficácia, Segurança e Farmacocinética de Cagrilintida s.c. 2,4 mg em Monoterapia e em Combinação com Semaglutida s.c. 2,4 mg (CagriSema) Uma Vez por Semana para Gestão de Peso em Crianças e Adolescentes com Excesso de Peso ou Obesidade
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Novo Nordisk
- Número de telefone: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Locais de estudo
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New South Wales
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Westmead, New South Wales, Austrália, 2145
- Recrutamento
- The Children's Hospital at Westmead - Clinical Research Centre
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Queensland
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South Brisbane, Queensland, Austrália, 4101
- Recrutamento
- Queensland Children's Hospital
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Western Australia
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Nedlands, Western Australia, Austrália, 6009
- Recrutamento
- Perth Children's Hospital
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Plovdiv, Bulgária, 4001
- Recrutamento
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
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Sofia, Bulgária, 1618
- Ainda não está recrutando
- Medical center Children's Health EOOD
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Sofia, Bulgária, 1606
- Recrutamento
- SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
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Varna, Bulgária, 9010
- Recrutamento
- UMHAT Sveta Marina EAD, First Pediatric Clinic
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Brussels, Bélgica, 1090
- Recrutamento
- UZ Brussel - Universitair Ziekenhuis Brussel
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Edegem, Bélgica, 2650
- Recrutamento
- UZA - Universitair Ziekenhuis Antwerpen
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100045
- Ainda não está recrutando
- Beijing Children's Hospital, Capital Medical University
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Beijing, Beijing Municipality, China, 100020
- Recrutamento
- Capital Center for Children's Health, Capital Medical University-Endocrinology
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Henan
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Zhengzhou, Henan, China, 450018
- Recrutamento
- Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
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Hubei
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Wuhan, Hubei, China, 430019
- Recrutamento
- Wuhan Children Hospital-Endocrine Genetics and Metabolism
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Wuhan, Hubei, China, 430030
- Recrutamento
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
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Jilin
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Changchun, Jilin, China, 130021
- Ainda não está recrutando
- The First Bethune Hospital of Jilin University-Pediatric
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Shandong
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Jinan, Shandong, China, 250098
- Recrutamento
- Shandong Provincial Hospital-Pediatric
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201102
- Recrutamento
- Children's Hospital of Fudan University-Endocrinology and Metabolism
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Sichuan
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Chengdu, Sichuan, China, 610031
- Recrutamento
- Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
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Bogotá, Colômbia, 110111
- Ainda não está recrutando
- Fundación Santa Fe de Bogotá
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Antioquia
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Medellín, Antioquia, Colômbia, 05001
- Ainda não está recrutando
- Servicios de Salud Ips Suramericana S.A.S.
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Rijeka, Croácia, 51 000
- Ainda não está recrutando
- Clinical Hospital Centre Rijeka_Pediatric
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Zagreb, Croácia, 10 000
- Ainda não está recrutando
- KBC "Sestre Milosrdnice"
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Zagreb, Croácia, 10000
- Ainda não está recrutando
- Klinika Za Djecje Bolesti Zagreb_Endocrinology
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Aalborg, Dinamarca, 9000
- Ainda não está recrutando
- Aalborg Universitetshospital - Børne og Ungeafdelingen
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Holbæk, Dinamarca, 4300
- Recrutamento
- Holbæk Sygehus - Børne- og Ungeafdelingen
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Bratislava, Eslováquia, 833 40
- Ainda não está recrutando
- Narodny Ustav Detskych Chorob
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Košice, Eslováquia, 040 01
- Recrutamento
- Detska Fakultna nemocnica Kosice
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Poprad, Eslováquia, 058 45
- Ainda não está recrutando
- Nemocnica Poprad, a.s.
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Ľubochňa, Eslováquia, 03491
- Recrutamento
- Narodny Endokrinologicky a diabetologicky ustav
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Barcelona, Espanha, 08035
- Ainda não está recrutando
- Hosp. Vall d'Hebrón_Endocrinología pediatríca
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Esplugues de Llobregat, Espanha, 08950
- Ainda não está recrutando
- Hospital Sant Joan de Déu
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Seville, Espanha, 41013
- Ainda não está recrutando
- Hospital Universitario Virgen del Rocío
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California
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Escondido, California, Estados Unidos, 92025
- Recrutamento
- Neighborhood Healthcare
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Florida
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Hollywood, Florida, Estados Unidos, 33024
- Recrutamento
- Encore Medical Research LLC
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Jacksonville, Florida, Estados Unidos, 32216
- Recrutamento
- Jacksonville Ctr for Clin Res
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Weston, Florida, Estados Unidos, 33331
- Recrutamento
- Encore Medical Research of Weston
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Georgia
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Atlanta, Georgia, Estados Unidos, 30329
- Recrutamento
- Children's Healthcare Atlanta
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Columbus, Georgia, Estados Unidos, 31904
- Recrutamento
- Columbus Research Foundation
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Decatur, Georgia, Estados Unidos, 30030
- Recrutamento
- Accel Research Sites-NeuroStudies
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Snellville, Georgia, Estados Unidos, 30078
- Recrutamento
- Eastside Bariatric and Gen Surg
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
- Recrutamento
- Solaris Clinical Research
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Recrutamento
- IU Health - Riley Physicians Endo-Diab
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Recrutamento
- Cotton O'Neil Clinical Research Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808-4124
- Recrutamento
- Pennington Biomed Res Ctr
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Maryland
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Baltimore, Maryland, Estados Unidos, 21229
- Recrutamento
- Barry J. Reiner, MD LLC
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Recrutamento
- University of Minnesota
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Richfield, Minnesota, Estados Unidos, 55423
- Recrutamento
- Synexus Clinical Research US-MN
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New York
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Buffalo, New York, Estados Unidos, 14203
- Ainda não está recrutando
- UBMD Physicians Group - Pediatrics - Conventus
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Syracuse, New York, Estados Unidos, 13210
- Recrutamento
- SUNY Upstate Medical Univ - Syracuse
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The Bronx, New York, Estados Unidos, 10467
- Ainda não está recrutando
- Advantage Clinical Trials
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58104
- Recrutamento
- Valley Weight Loss Clinic
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Ohio
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Columbus, Ohio, Estados Unidos, 43213
- Recrutamento
- Centricity Research - Ohio
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Dayton, Ohio, Estados Unidos, 45429
- Recrutamento
- PriMed Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Ainda não está recrutando
- Children's Physicians OU
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Ainda não está recrutando
- UPMC Child Hosp-Pittsburgh
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Ainda não está recrutando
- Prisma Health-Ped Endo
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North Charleston, South Carolina, Estados Unidos, 29405
- Recrutamento
- Coastal Carolina Research Ctr
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Ainda não está recrutando
- Monument Health Clinical Rsrch
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38115
- Recrutamento
- LifeDoc Health
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Texas
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Houston, Texas, Estados Unidos, 77065
- Recrutamento
- DM Clinical
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San Antonio, Texas, Estados Unidos, 78215
- Recrutamento
- The Texas Liver Institute
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San Antonio, Texas, Estados Unidos, 78207
- Ainda não está recrutando
- DM Clinical
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San Antonio, Texas, Estados Unidos, 78222
- Recrutamento
- Pinnacle Clinical Research
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Shavano Park, Texas, Estados Unidos, 78231
- Recrutamento
- Consano Clin Res-Shavano Park
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Weslaco, Texas, Estados Unidos, 78596
- Recrutamento
- Texas Valley Clinical Research
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Utah
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Layton, Utah, Estados Unidos, 84041
- Recrutamento
- AMR Clinical
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's-Hertogenbosch, Holanda, 5223 GZ
- Ainda não está recrutando
- Jeroen Bosch Zkh
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Amersfoort, Holanda, 3813 TZ
- Concluído
- Meander MC
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Budapest, Hungria, 1083
- Ainda não está recrutando
- Semmelweis Egyetem ÁOK
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Budapest, Hungria, 1023
- Recrutamento
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
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Szeged, Hungria, 6720
- Ainda não está recrutando
- Szegedi Tudományegyetem Gyermekgyógyászati Klinika
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Haifa, Israel, 31096
- Ainda não está recrutando
- Rambam MC - Department of Pediatrics A
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Jerusalem, Israel, 9103102
- Ainda não está recrutando
- Shaare Zedek MC - Endocrinology Department
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Petah Tikva, Israel, 49202
- Ainda não está recrutando
- Schneider MC - Endrocrinology and Diabetes
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Tsrifin, Israel, 7033001
- Ainda não está recrutando
- Shamir MC - Pediatric and Adolescents Endocrinology unit
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Trieste, Itália, 34137
- Ainda não está recrutando
- IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
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Lombardy
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Milan, Lombardy, Itália, 20122
- Ainda não está recrutando
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
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Piedmont
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Novara, Piedmont, Itália, 28100
- Ainda não está recrutando
- AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
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Veneto
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Verona, Veneto, Itália, 37126
- Ainda não está recrutando
- A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
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Kuala Lumpur
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Kampung Baru, Kuala Lumpur, Malásia, 50300
- Ainda não está recrutando
- Hospital Tunku Azizah
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Lembah Pantai, Kuala Lumpur, Malásia, 59100
- Recrutamento
- University Malaya Medical Centre
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Sarawak
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Sibu, Sarawak, Malásia, 96000
- Recrutamento
- Hospital Sibu
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Puebla City, México, 72190
- Ainda não está recrutando
- Consultorio de Endocrinología y Pediatría
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Nuevo León
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Monterrey, Nuevo León, México, 64060
- Ainda não está recrutando
- CHRISTUS - Latam Hub Excellence and Innovation Center
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Monterrey, Nuevo León, México, 64310
- Ainda não está recrutando
- IECSI Centro de Investigación Clínica
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Dziekanów Leśny, Polônia, 05-092
- Ainda não está recrutando
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
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Opole, Polônia, 45-401
- Ainda não está recrutando
- Uniwersytecki Szpital Kliniczny w Opolu
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Rzeszów, Polônia, 35-301
- Ainda não está recrutando
- Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
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Zabrze, Polônia, 41-800
- Ainda não está recrutando
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
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Porto, Portugal, 4050-651
- Ainda não está recrutando
- ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
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Porto, Portugal, 4100-180
- Ainda não está recrutando
- CUF Porto_Serviço de Pediatria
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Vila Nova de Gaia, Portugal, 4434-502
- Ainda não está recrutando
- ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
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Birmingham, Reino Unido, B4 6NH
- Recrutamento
- Birmingham Children's Hospital
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Liverpool, Reino Unido, L12 2AP
- Recrutamento
- Alder Hey Children's Hospital
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London, Reino Unido, NW1 1BU
- Recrutamento
- University College Hospital - Paediatric Services
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Baia Mare, Romênia, 430031
- Ainda não está recrutando
- Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
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Bucharest, Romênia, 041451
- Recrutamento
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
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Bucharest, Romênia, 010073
- Recrutamento
- Kilostop Junior SRL
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Timișoara, Romênia, 300226
- Recrutamento
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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Umeå, Suécia, 907 37
- Ainda não está recrutando
- Barn och ungdomscentrum Västerbotten - NU
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Uppsala, Suécia, 75185
- Ainda não está recrutando
- Akademiska barnsjukhuset - klinisk forskningsmottagning
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Belgrade, Sérvia, 11000
- Recrutamento
- University Children's Hospital Tirsova
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Belgrade, Sérvia, 11070
- Recrutamento
- Institute for Mother and Child Health Care of Serbia
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Novi Sad, Sérvia, 21000
- Recrutamento
- Institute for Health Care of Children and Adolescents
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Bangkok, Tailândia, 10300
- Recrutamento
- King Chulalongkorn Memorial Hospital_Ped-Nutrition
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Pathum Thani, Tailândia, 12120
- Recrutamento
- Thammasat Hospital_CRC
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Kaohsiung City, Taiwan, 833
- Recrutamento
- Chang Gung Memorial Hospital - Kaohsiung Branch
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Taichung, Taiwan, 402
- Recrutamento
- Chung Shan Medical University Hospital
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Taipei, Taiwan, 104
- Recrutamento
- Taipei Mackay Children's Hospital
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Taoyuan, Taiwan, 333
- Recrutamento
- Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
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Innsbruck, Áustria, 6020
- Recrutamento
- Universitätsklinik Kinder-Jugendheilkunde Innsbruck
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Salzburg, Áustria, 5020
- Recrutamento
- Universitätsklinik für Kinder und Jugendheilkunde Haus E
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Kolhāpur, Índia, 416008
- Ainda não está recrutando
- Excel Endocrine Centre
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New Delhi, Índia, 110029
- Ainda não está recrutando
- All India Institute of Medical Sciences (AIIMS)
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Andhra Pradesh
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Guntur, Andhra Pradesh, Índia, 522001
- Ainda não está recrutando
- Endolife Specialty Hospitals
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Gujarat
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Surat, Gujarat, Índia, 395009
- Ainda não está recrutando
- BAPS Pramukh Swami Hospital
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Karnataka
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Bangalore, Karnataka, Índia, 560011
- Ainda não está recrutando
- 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, Índia, 110060
- Ainda não está recrutando
- Sir Ganga Ram Hospital
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New Delhi
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Delhi, New Delhi, Índia, 110002
- Ainda não está recrutando
- Maulana Azad Medical College
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Uttar Pradesh
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Kanpur, Uttar Pradesh, Índia, 208006
- Ainda não está recrutando
- Regency Hospital
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West Bengal
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Kolkata, West Bengal, Índia, 700017
- Ainda não está recrutando
- Institute of Child Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks. |
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. |
|
Experimental: Semaglutide
Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. |
Participants will receive semaglutide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
|
Experimental: Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks. |
Participants will receive cagrilintide subcutaneously. Participants will receive placebo matched to cagrilintide subcutaneously. |
|
Comparador de 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative change in body mass index (BMI)
Prazo: Baseline (week 0), week 68
|
Measured in percentage (%). |
Baseline (week 0), week 68
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relative change in body weight
Prazo: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Change in BMI Standard Deviation Score (SDS)
Prazo: Baseline (week 0), week 68
|
Measured as SDS score. |
Baseline (week 0), week 68
|
|
Relative change in BMI
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved normal BMI
Prazo: 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
Prazo: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Change in waist circumference
Prazo: 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
Prazo: 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)
Prazo: Baseline (week 0), week 68
|
Measured in kilograms (kg). |
Baseline (week 0), week 68
|
|
Relative to baseline change in total fat mass by DXA
Prazo: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in total fat mass by DXA
Prazo: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in visceral fat mass by DXA
Prazo: Baseline (week 0), week 68
|
Measured in kg. |
Baseline (week 0), week 68
|
|
Relative to baseline change in visceral fat mass by DXA
Prazo: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in visceral fat mass by DXA
Prazo: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in lean body mass by DXA
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Prazo: Baseline (week 0), week 68
|
Measured as ratio. |
Baseline (week 0), week 68
|
|
Ratio to baseline in lipids: Total cholesterol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in Alanine Transaminase (ALT)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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])
Prazo: 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])
Prazo: Baseline (week 0), week 68
|
Measured in mmol/L. |
Baseline (week 0), week 68
|
|
Change in FPG (milligrams per deciliter [mg/dL])
Prazo: Baseline (week 0), week 68
|
Measured in mg/dL. |
Baseline (week 0), week 68
|
|
Ratio to baseline in fasting serum insulin
Prazo: 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
Prazo: 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 %
Prazo: 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%
Prazo: 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%
Prazo: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants taking glucose lowering medication at baseline, stop or decrease
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Baseline (week 0), week 68
|
Measured in beats per minute (beats/min). |
Baseline (week 0), week 68
|
|
Change in calcitonin
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline (week 0), week 68
|
Measured in hours nanomoles per liter (h·nmol/L). |
Baseline (week 0), week 68
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NN9838-4968
- U1111-1299-4751 (Outro identificador: World Health Organization (WHO))
- 2023-509176-42 (Outro identificador: European Medical Agency (EMA))
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
Informações sobre medicamentos e dispositivos, documentos de estudo
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