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Un estudio de investigación sobre la eficacia de Cagrilintida y CagriSema en niños y adolescentes con exceso de peso corporal

28 de septiembre de 2026 actualizado por: Novo Nordisk A/S

Eficacia, seguridad y farmacocinética de Cagrilintida s.c. 2,4 mg como monoterapia y en combinación con Semaglutida s.c. 2,4 mg (CagriSema) una vez por semana para el control de peso en niños y adolescentes con sobrepeso u obesidad

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

460

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Nombre: Novo Nordisk
Número de teléfono: (+1) 866-867-7178
Correo electrónico: clinicaltrials@novonordisk.com

Ubicaciones de estudio

Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Reclutamiento
    - The Children's Hospital at Westmead - Clinical Research Centre
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Reclutamiento
    - Queensland Children's Hospital
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Reclutamiento
    - Perth Children's Hospital
Austria
- - Innsbruck, Austria, 6020
    - Reclutamiento
    - Universitätsklinik Kinder-Jugendheilkunde Innsbruck
  - Salzburg, Austria, 5020
    - Reclutamiento
    - Universitätsklinik für Kinder und Jugendheilkunde Haus E
Bulgaria
- - Plovdiv, Bulgaria, 4001
    - Reclutamiento
    - UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
  - Sofia, Bulgaria, 1618
    - Aún no reclutando
    - Medical center Children's Health EOOD
  - Sofia, Bulgaria, 1606
    - Reclutamiento
    - SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
  - Varna, Bulgaria, 9010
    - Reclutamiento
    - UMHAT Sveta Marina EAD, First Pediatric Clinic
Bélgica
- - Brussels, Bélgica, 1090
    - Reclutamiento
    - UZ Brussel - Universitair Ziekenhuis Brussel
  - Edegem, Bélgica, 2650
    - Reclutamiento
    - UZA - Universitair Ziekenhuis Antwerpen
Colombia
- - Bogotá, Colombia, 110111
    - Aún no reclutando
    - Fundación Santa Fe de Bogotá
- Antioquia
  - Medellín, Antioquia, Colombia, 05001
    - Aún no reclutando
    - Servicios de Salud Ips Suramericana S.A.S.
Croacia
- - Rijeka, Croacia, 51 000
    - Aún no reclutando
    - Clinical Hospital Centre Rijeka_Pediatric
  - Zagreb, Croacia, 10 000
    - Aún no reclutando
    - KBC "Sestre Milosrdnice"
  - Zagreb, Croacia, 10000
    - Aún no reclutando
    - Klinika Za Djecje Bolesti Zagreb_Endocrinology
Dinamarca
- - Aalborg, Dinamarca, 9000
    - Aún no reclutando
    - Aalborg Universitetshospital - Børne og Ungeafdelingen
  - Holbæk, Dinamarca, 4300
    - Reclutamiento
    - Holbæk Sygehus - Børne- og Ungeafdelingen
Eslovaquia
- - Bratislava, Eslovaquia, 833 40
    - Aún no reclutando
    - Narodny Ustav Detskych Chorob
  - Košice, Eslovaquia, 040 01
    - Reclutamiento
    - Detska Fakultna nemocnica Kosice
  - Poprad, Eslovaquia, 058 45
    - Aún no reclutando
    - Nemocnica Poprad, a.s.
  - Ľubochňa, Eslovaquia, 03491
    - Reclutamiento
    - Narodny Endokrinologicky a diabetologicky ustav
España
- - Barcelona, España, 08035
    - Aún no reclutando
    - Hosp. Vall d'Hebrón_Endocrinología pediatríca
  - Esplugues de Llobregat, España, 08950
    - Aún no reclutando
    - Hospital Sant Joan de Déu
  - Seville, España, 41013
    - Aún no reclutando
    - Hospital Universitario Virgen del Rocío
Estados Unidos
- California
  - Escondido, California, Estados Unidos, 92025
    - Reclutamiento
    - Neighborhood Healthcare
- Florida
  - Hollywood, Florida, Estados Unidos, 33024
    - Reclutamiento
    - Encore Medical Research LLC
  - Jacksonville, Florida, Estados Unidos, 32216
    - Reclutamiento
    - Jacksonville Ctr for Clin Res
  - Weston, Florida, Estados Unidos, 33331
    - Reclutamiento
    - Encore Medical Research of Weston
- Georgia
  - Atlanta, Georgia, Estados Unidos, 30329
    - Reclutamiento
    - Children's Healthcare Atlanta
  - Columbus, Georgia, Estados Unidos, 31904
    - Reclutamiento
    - Columbus Research Foundation
  - Decatur, Georgia, Estados Unidos, 30030
    - Reclutamiento
    - Accel Research Sites-NeuroStudies
  - Snellville, Georgia, Estados Unidos, 30078
    - Reclutamiento
    - Eastside Bariatric and Gen Surg
- Idaho
  - Meridian, Idaho, Estados Unidos, 83646
    - Reclutamiento
    - Solaris Clinical Research
- Indiana
  - Indianapolis, Indiana, Estados Unidos, 46202
    - Reclutamiento
    - IU Health - Riley Physicians Endo-Diab
- Kansas
  - Topeka, Kansas, Estados Unidos, 66606
    - Reclutamiento
    - Cotton O'Neil Clinical Research Center
- Louisiana
  - Baton Rouge, Louisiana, Estados Unidos, 70808-4124
    - Reclutamiento
    - Pennington Biomed Res Ctr
- Maryland
  - Baltimore, Maryland, Estados Unidos, 21229
    - Reclutamiento
    - Barry J. Reiner, MD LLC
- Minnesota
  - Minneapolis, Minnesota, Estados Unidos, 55455
    - Reclutamiento
    - University of Minnesota
  - Richfield, Minnesota, Estados Unidos, 55423
    - Reclutamiento
    - Synexus Clinical Research US-MN
- New York
  - Buffalo, New York, Estados Unidos, 14203
    - Aún no reclutando
    - UBMD Physicians Group - Pediatrics - Conventus
  - Syracuse, New York, Estados Unidos, 13210
    - Reclutamiento
    - SUNY Upstate Medical Univ - Syracuse
  - The Bronx, New York, Estados Unidos, 10467
    - Aún no reclutando
    - Advantage Clinical Trials
- North Dakota
  - Fargo, North Dakota, Estados Unidos, 58104
    - Reclutamiento
    - Valley Weight Loss Clinic
- Ohio
  - Columbus, Ohio, Estados Unidos, 43213
    - Reclutamiento
    - Centricity Research - Ohio
  - Dayton, Ohio, Estados Unidos, 45429
    - Reclutamiento
    - PriMed Clinical Research
- Oklahoma
  - Oklahoma City, Oklahoma, Estados Unidos, 73104
    - Aún no reclutando
    - Children's Physicians OU
- Pennsylvania
  - Pittsburgh, Pennsylvania, Estados Unidos, 15224
    - Aún no reclutando
    - UPMC Child Hosp-Pittsburgh
- South Carolina
  - Greenville, South Carolina, Estados Unidos, 29615
    - Aún no reclutando
    - Prisma Health-Ped Endo
  - North Charleston, South Carolina, Estados Unidos, 29405
    - Reclutamiento
    - Coastal Carolina Research Ctr
- South Dakota
  - Rapid City, South Dakota, Estados Unidos, 57701
    - Aún no reclutando
    - Monument Health Clinical Rsrch
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38115
    - Reclutamiento
    - LifeDoc Health
- Texas
  - Houston, Texas, Estados Unidos, 77065
    - Reclutamiento
    - DM Clinical
  - San Antonio, Texas, Estados Unidos, 78215
    - Reclutamiento
    - The Texas Liver Institute
  - San Antonio, Texas, Estados Unidos, 78207
    - Aún no reclutando
    - DM Clinical
  - San Antonio, Texas, Estados Unidos, 78222
    - Reclutamiento
    - Pinnacle Clinical Research
  - Shavano Park, Texas, Estados Unidos, 78231
    - Reclutamiento
    - Consano Clin Res-Shavano Park
  - Weslaco, Texas, Estados Unidos, 78596
    - Reclutamiento
    - Texas Valley Clinical Research
- Utah
  - Layton, Utah, Estados Unidos, 84041
    - Reclutamiento
    - AMR Clinical
Hungría
- - Budapest, Hungría, 1083
    - Aún no reclutando
    - Semmelweis Egyetem ÁOK
  - Budapest, Hungría, 1023
    - Reclutamiento
    - Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
  - Szeged, Hungría, 6720
    - Aún no reclutando
    - Szegedi Tudományegyetem Gyermekgyógyászati Klinika
India
- - Kolhāpur, India, 416008
    - Aún no reclutando
    - Excel Endocrine Centre
  - New Delhi, India, 110029
    - Aún no reclutando
    - All India Institute of Medical Sciences (AIIMS)
- Andhra Pradesh
  - Guntur, Andhra Pradesh, India, 522001
    - Aún no reclutando
    - Endolife Specialty Hospitals
- Gujarat
  - Surat, Gujarat, India, 395009
    - Aún no reclutando
    - BAPS Pramukh Swami Hospital
- Karnataka
  - Bangalore, Karnataka, India, 560011
    - Aún no reclutando
    - Indira Gandhi Institute of child health
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Aún no reclutando
    - Sir Ganga Ram Hospital
- New Delhi
  - Delhi, New Delhi, India, 110002
    - Aún no reclutando
    - Maulana Azad Medical College
- Uttar Pradesh
  - Kanpur, Uttar Pradesh, India, 208006
    - Aún no reclutando
    - Regency Hospital
- West Bengal
  - Kolkata, West Bengal, India, 700017
    - Aún no reclutando
    - Institute of Child Health
Israel
- - Haifa, Israel, 31096
    - Aún no reclutando
    - Rambam MC - Department of Pediatrics A
  - Jerusalem, Israel, 9103102
    - Aún no reclutando
    - Shaare Zedek MC - Endocrinology Department
  - Petah Tikva, Israel, 49202
    - Aún no reclutando
    - Schneider MC - Endrocrinology and Diabetes
  - Tsrifin, Israel, 7033001
    - Aún no reclutando
    - Shamir MC - Pediatric and Adolescents Endocrinology unit
Italia
- - Trieste, Italia, 34137
    - Aún no reclutando
    - IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
- Lombardy
  - Milan, Lombardy, Italia, 20122
    - Aún no reclutando
    - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
- Piedmont
  - Novara, Piedmont, Italia, 28100
    - Aún no reclutando
    - AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
- Veneto
  - Verona, Veneto, Italia, 37126
    - Aún no reclutando
    - A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
Malasia
- Kuala Lumpur
  - Kampung Baru, Kuala Lumpur, Malasia, 50300
    - Aún no reclutando
    - Hospital Tunku Azizah
  - Lembah Pantai, Kuala Lumpur, Malasia, 59100
    - Reclutamiento
    - University Malaya Medical Centre
- Sarawak
  - Sibu, Sarawak, Malasia, 96000
    - Reclutamiento
    - Hospital Sibu
México
- - Puebla City, México, 72190
    - Aún no reclutando
    - Consultorio de Endocrinología y Pediatría
- Nuevo León
  - Monterrey, Nuevo León, México, 64060
    - Aún no reclutando
    - CHRISTUS - Latam Hub Excellence and Innovation Center
  - Monterrey, Nuevo León, México, 64310
    - Aún no reclutando
    - IECSI Centro de Investigación Clínica
Países Bajos
- - 's-Hertogenbosch, Países Bajos, 5223 GZ
    - Aún no reclutando
    - Jeroen Bosch Zkh
  - Amersfoort, Países Bajos, 3813 TZ
    - Terminado
    - Meander MC
Polonia
- - Dziekanów Leśny, Polonia, 05-092
    - Aún no reclutando
    - Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
  - Opole, Polonia, 45-401
    - Aún no reclutando
    - Uniwersytecki Szpital Kliniczny w Opolu
  - Rzeszów, Polonia, 35-301
    - Aún no reclutando
    - Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
  - Zabrze, Polonia, 41-800
    - Aún no reclutando
    - Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Porcelana
- Beijing Municipality
  - Beijing, Beijing Municipality, Porcelana, 100045
    - Aún no reclutando
    - Beijing Children's Hospital, Capital Medical University
  - Beijing, Beijing Municipality, Porcelana, 100020
    - Reclutamiento
    - Capital Center for Children's Health, Capital Medical University-Endocrinology
- Henan
  - Zhengzhou, Henan, Porcelana, 450018
    - Reclutamiento
    - Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
- Hubei
  - Wuhan, Hubei, Porcelana, 430019
    - Reclutamiento
    - Wuhan Children Hospital-Endocrine Genetics and Metabolism
  - Wuhan, Hubei, Porcelana, 430030
    - Reclutamiento
    - Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
- Jilin
  - Changchun, Jilin, Porcelana, 130021
    - Aún no reclutando
    - The First Bethune Hospital of Jilin University-Pediatric
- Shandong
  - Jinan, Shandong, Porcelana, 250098
    - Reclutamiento
    - Shandong Provincial Hospital-Pediatric
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Porcelana, 201102
    - Reclutamiento
    - Children's Hospital of Fudan University-Endocrinology and Metabolism
- Sichuan
  - Chengdu, Sichuan, Porcelana, 610031
    - Reclutamiento
    - Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
Portugal
- - Porto, Portugal, 4050-651
    - Aún no reclutando
    - ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
  - Porto, Portugal, 4100-180
    - Aún no reclutando
    - CUF Porto_Serviço de Pediatria
  - Vila Nova de Gaia, Portugal, 4434-502
    - Aún no reclutando
    - ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
Reino Unido
- - Birmingham, Reino Unido, B4 6NH
    - Reclutamiento
    - Birmingham Children's Hospital
  - Liverpool, Reino Unido, L12 2AP
    - Reclutamiento
    - Alder Hey Children's Hospital
  - London, Reino Unido, NW1 1BU
    - Reclutamiento
    - University College Hospital - Paediatric Services
Rumania
- - Baia Mare, Rumania, 430031
    - Aún no reclutando
    - Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
  - Bucharest, Rumania, 041451
    - Reclutamiento
    - Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
  - Bucharest, Rumania, 010073
    - Reclutamiento
    - Kilostop Junior SRL
  - Timișoara, Rumania, 300226
    - Reclutamiento
    - Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Serbia
- - Belgrade, Serbia, 11000
    - Reclutamiento
    - University Children's Hospital Tirsova
  - Belgrade, Serbia, 11070
    - Reclutamiento
    - Institute for Mother and Child Health Care of Serbia
  - Novi Sad, Serbia, 21000
    - Reclutamiento
    - Institute for Health Care of Children and Adolescents
Suecia
- - Umeå, Suecia, 907 37
    - Aún no reclutando
    - Barn och ungdomscentrum Västerbotten - NU
  - Uppsala, Suecia, 75185
    - Aún no reclutando
    - Akademiska barnsjukhuset - klinisk forskningsmottagning
Tailandia
- - Bangkok, Tailandia, 10300
    - Reclutamiento
    - King Chulalongkorn Memorial Hospital_Ped-Nutrition
  - Pathum Thani, Tailandia, 12120
    - Reclutamiento
    - Thammasat Hospital_CRC
Taiwán
- - Kaohsiung City, Taiwán, 833
    - Reclutamiento
    - Chang Gung Memorial Hospital - Kaohsiung Branch
  - Taichung, Taiwán, 402
    - Reclutamiento
    - Chung Shan Medical University Hospital
  - Taipei, Taiwán, 104
    - Reclutamiento
    - Taipei Mackay Children's Hospital
  - Taoyuan, Taiwán, 333
    - Reclutamiento
    - Chang Gung Memorial Hospital Linkou-Dept of Pediatrics

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

8 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Cuadruplicar

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
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.	Droga: Cagrilintide Participants will receive cagrilintide subcutaneously. Droga: Semaglutide Participants will receive semaglutide subcutaneously. Droga: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Droga: Placebo semaglutide 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.	Droga: Semaglutide Participants will receive semaglutide subcutaneously. Droga: Placebo semaglutide 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.	Droga: Cagrilintide Participants will receive cagrilintide subcutaneously. Droga: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously.
Comparador de placebos: 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.	Droga: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Droga: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Relative change in body mass index (BMI) Periodo de tiempo: Baseline (week 0), week 68	Measured in percentage (%).	Baseline (week 0), week 68

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Relative change in body weight Periodo de tiempo: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS) Periodo de tiempo: Baseline (week 0), week 68	Measured as SDS score.	Baseline (week 0), week 68
Relative change in BMI Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved normal BMI Periodo de tiempo: 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 Periodo de tiempo: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Change in waist circumference Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: Baseline (week 0), week 68	Measured in kilograms (kg).	Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA Periodo de tiempo: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA Periodo de tiempo: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA Periodo de tiempo: Baseline (week 0), week 68	Measured in kg.	Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA Periodo de tiempo: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA Periodo de tiempo: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Absolute change in lean body mass by DXA Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP) Periodo de tiempo: Baseline (week 0), week 68	Measured as ratio.	Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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]) Periodo de tiempo: 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]) Periodo de tiempo: Baseline (week 0), week 68	Measured in mmol/L.	Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL]) Periodo de tiempo: Baseline (week 0), week 68	Measured in mg/dL.	Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin Periodo de tiempo: 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 Periodo de tiempo: 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 % Periodo de tiempo: 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% Periodo de tiempo: 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% Periodo de tiempo: At week 68	Measured as count of participants.	At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: Baseline (week 0), week 68	Measured in beats per minute (beats/min).	Baseline (week 0), week 68
Change in calcitonin Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: Baseline (week 0), week 68	Measured in hours nanomoles per liter (h·nmol/L).	Baseline (week 0), week 68

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novo Nordisk A/S

Investigadores

Director de estudio: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de enero de 2026

Finalización primaria (Estimado)

20 de marzo de 2030

Finalización del estudio (Estimado)

20 de septiembre de 2033

Fechas de registro del estudio

Enviado por primera vez

19 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2025

Publicado por primera vez (Actual)

28 de noviembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

NN9838-4968
U1111-1299-4751 (Otro identificador: World Health Organization (WHO))
2023-509176-42 (Otro identificador: European Medical Agency (EMA))
2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Un estudio de investigación sobre la eficacia de Cagrilintida y CagriSema en niños y adolescentes con exceso de peso corporal

Eficacia, seguridad y farmacocinética de Cagrilintida s.c. 2,4 mg como monoterapia y en combinación con Semaglutida s.c. 2,4 mg (CagriSema) una vez por semana para el control de peso en niños y adolescentes con sobrepeso u obesidad

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Inscripción (Estimado)

Fase

Contactos y Ubicaciones

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Medidas de resultado secundarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Colaboradores e Investigadores

Patrocinador

Investigadores

Fechas de registro del estudio

Fechas importantes del estudio

Inicio del estudio (Actual)

Finalización primaria (Estimado)

Finalización del estudio (Estimado)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Actual)

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.