Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Výzkumná studie o tom, jak dobře funguje Cagrilintid a CagriSema u dětí a dospívajících s nadváhou

28. září 2026 aktualizováno: Novo Nordisk A/S

Účinnost, bezpečnost a farmakokinetika přípravku Cagrilintid s.c. 2,4 mg jako monoterapie a v kombinaci se semaglutidem s.c. 2,4 mg (CagriSema) podávaného jednou týdně pro zvládání hmotnosti u dětí a dospívajících s nadváhou nebo obezitou

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

460

Fáze

Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Novo Nordisk
Telefonní číslo: (+1) 866-867-7178
E-mail: clinicaltrials@novonordisk.com

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 18 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Čtyřnásobek

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: 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.	Lék: Cagrilintide Participants will receive cagrilintide subcutaneously. Lék: Semaglutide Participants will receive semaglutide subcutaneously. Lék: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Lék: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Experimentální: 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.	Lék: Semaglutide Participants will receive semaglutide subcutaneously. Lék: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Experimentální: 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.	Lék: Cagrilintide Participants will receive cagrilintide subcutaneously. Lék: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously.
Komparátor placeba: 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.	Lék: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Lék: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Relative change in body mass index (BMI) Časové okno: Baseline (week 0), week 68	Measured in percentage (%).	Baseline (week 0), week 68

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novo Nordisk A/S

Vyšetřovatelé

Ředitel studie: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

8. ledna 2026

Primární dokončení (Odhadovaný)

20. března 2030

Dokončení studie (Odhadovaný)

20. září 2033

Termíny zápisu do studia

První předloženo

19. listopadu 2025

První předloženo, které splnilo kritéria kontroly kvality

19. listopadu 2025

První zveřejněno (Aktuální)

28. listopadu 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NN9838-4968
U1111-1299-4751 (Jiný identifikátor: World Health Organization (WHO))
2023-509176-42 (Jiný identifikátor: European Medical Agency (EMA))
2023 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Výzkumná studie o tom, jak dobře funguje Cagrilintid a CagriSema u dětí a dospívajících s nadváhou

Účinnost, bezpečnost a farmakokinetika přípravku Cagrilintid s.c. 2,4 mg jako monoterapie a v kombinaci se semaglutidem s.c. 2,4 mg (CagriSema) podávaného jednou týdně pro zvládání hmotnosti u dětí a dospívajících s nadváhou nebo obezitou

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Typ studie

Zápis (Odhadovaný)

Fáze

Kontakty a umístění

Studijní kontakt

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Vyšetřovatelé

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Odhadovaný)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA