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Et forskningsstudie om, hvor godt Cagrilintid og CagriSema virker hos børn og unge med overvægt

28. september 2026 opdateret af: Novo Nordisk A/S

Effekt, sikkerhed og farmakokinetik for Cagrilintide s.c. 2,4 mg som monoterapi og i kombination med Semaglutide s.c. 2,4 mg (CagriSema) en gang ugentligt til vægtstyring hos børn og unge med overvægt eller fedme

This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

460

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Novo Nordisk
Telefonnummer: (+1) 866-867-7178
E-mail: clinicaltrials@novonordisk.com

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
Male or female.
Aged 8 to less than (<) 18 years at the time of signing the informed consent.
Body mass index (BMI), at screening, corresponding to:
Greater than or equal to (>=) 95th percentile for children aged 8 to < 12 years (Tanner stage 1-5)
>= 95th percentile or >= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to < 18 years (Tanner stage 2-5).
Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone.
History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months.
Body weight greater than (>) 45 kilograms (kg) at screening.

For participants with T2D at screening the following inclusion criteria also apply

Glycated haemoglobin (HbA1c) less than or equal to (<=)10.0 percent (%) (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening.
Treatment with lifestyle intervention or treatment with metformin according to local label.
Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening.

Key exclusion criteria:

Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
Liposuction and/or abdominoplasty, if performed > 1 year before screening.
Adjustable gastric banding, if the band has been removed > 1 year before screening.
Intragastric balloon, if the balloon has been removed > 1 year before screening.
Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year before screening.
Uncontrolled thyroid disease.
Endocrine, hypothalamic, or syndromic obesity.
A self-reported (or by parent(s)/LAR, where applicable) change in body weight > 5 % within 90 days before screening irrespective of medical records.
Type 1 diabetes or monogenic diabetes. For participants without T2D at screening the following exclusion criteria also apply
HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening.

For participants with T2D at screening the following exclusion criteria also apply

Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire.
Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator.
Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 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.	Medicin: Cagrilintide Participants will receive cagrilintide subcutaneously. Medicin: Semaglutide Participants will receive semaglutide subcutaneously. Medicin: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Medicin: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Eksperimentel: 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.	Medicin: Semaglutide Participants will receive semaglutide subcutaneously. Medicin: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Eksperimentel: 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.	Medicin: Cagrilintide Participants will receive cagrilintide subcutaneously. Medicin: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo komparator: Placebo Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks.	Medicin: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Medicin: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Relative change in body mass index (BMI) Tidsramme: Baseline (week 0), week 68	Measured in percentage (%).	Baseline (week 0), week 68

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Relative change in body weight Tidsramme: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS) Tidsramme: Baseline (week 0), week 68	Measured as SDS score.	Baseline (week 0), week 68
Relative change in BMI Tidsramme: Baseline (week 0), week 68 and week 224	Measured in %.	Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of body weight (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of body weight (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of body weight (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of body weight (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=5% reduction of BMI (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of BMI (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of BMI (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of BMI (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of BMI (yes/no) Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved normal BMI Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who shifted from obese to non-obese BMI class Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Change in waist circumference Tidsramme: Baseline (week 0), week 68 and week 224	Measured in centimeter (cm).	Baseline (week 0), week 68 and week 224
Change in waist-to-height ratio Tidsramme: Baseline (week 0), week 68	Measured as ratio.	Baseline (week 0), week 68
Absolute change in total fat mass by dual energy X-ray absorption (DXA) Tidsramme: Baseline (week 0), week 68	Measured in kilograms (kg).	Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in kg.	Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Absolute change in lean body mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in kg.	Baseline (week 0), week 68
Relative to total body mass change in lean body mass by DXA Tidsramme: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in liters (L).	Baseline (week 0), week 68 and week 224
Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in %.	Baseline (week 0), week 68 and week 224
Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration Tidsramme: Baseline (week 0), week 68 and week 224	Measured in % points.	Baseline (week 0), week 68 and week 224
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in liters.	Baseline (week 0), week 68 and week 224
Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in %.	Baseline (week 0), week 68 and week 224
Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in liters.	Baseline (week 0), week 68 and week 224
Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat Tidsramme: Baseline (week 0), week 68 and week 224	Measured in %.	Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE) Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in BMI percentage of the 95th percentile Tidsramme: Baseline (week 0), week 68	Measured in % points.	Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP) Tidsramme: Baseline (week 0), week 68	Measured as ratio.	Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Triglycerides Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Non-HDL cholesterol Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT) Tidsramme: Baseline (week 0), week 68 and week 224	Measured in Units per Liter (U/L).	Baseline (week 0), week 68 and week 224
Change in systolic blood pressure Tidsramme: Baseline (week 0), week 68 and week 224	Measured in millimeters of mercury (mmHg).	Baseline (week 0), week 68 and week 224
Change in diastolic blood pressure Tidsramme: Baseline (week 0), week 68 and week 224	Measured in mmHg.	Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by ultrasonographic methods Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in glycated haemoglobin (HbA1c) (% points) Tidsramme: Baseline (week 0), week 68 and week 224	Measured in % points.	Baseline (week 0), week 68 and week 224
Change in HbA1c (millimoles per mole [mmol/mol]) Tidsramme: Baseline (week 0), week 68 and week 224	Measured in mmol/mol.	Baseline (week 0), week 68 and week 224
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L]) Tidsramme: Baseline (week 0), week 68	Measured in mmol/L.	Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL]) Tidsramme: Baseline (week 0), week 68	Measured in mg/dL.	Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin Tidsramme: Baseline (week 0), week 68 and week 224	Measured as ratio.	Baseline (week 0), week 68 and week 224
Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline Tidsramme: At week 68	Measured as count of participants.	At week 68
Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 % Tidsramme: At week 68	Measured as count of participants.	At week 68
Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5% Tidsramme: At week 68	Measured as count of participants.	At week 68
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5% Tidsramme: At week 68	Measured as count of participants.	At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants taking antihypertensive medication at baseline, stop or decrease Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Number of participants taking lipid lowering medication at baseline, stop or decrease Tidsramme: Baseline (week 0), week 68	Measured as count of participants.	Baseline (week 0), week 68
Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).	Baseline (week 0), week 68 and week 224
IWQOL Kids - Body esteem domain score Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).	Baseline (week 0), week 68 and week 224
IWQOL Kids - Social life domain score Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).	Baseline (week 0), week 68 and week 224
IWQOL Kids - Family-relations score Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).	Baseline (week 0), week 68 and week 224
IWQOL Kids - Total score Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. IWQOL-Kids measures weight-related quality of life in adolescents (ages 11-19 years) but will be administered to all study participants. The measure consists of 27-items yielding 4 sub-scale scores, and 1 total score. Higher scores indicate better weight-related quality of life. Subscale scores (score range): physical comfort (0-100), body esteem (0-100), social life (0-100), family relations (0-100) and total score (0-100).	Baseline (week 0), week 68 and week 224
Control of Eating Questionnaire (COEQ) Tidsramme: Baseline (week 0), week 68 and week 224	Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.	Baseline (week 0), week 68 and week 224
Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH) Tidsramme: Baseline (week 0), week 68 and week 224	Measured as counts.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent adverse events (TEAEs) Tidsramme: Baseline (week 0), week 68 and week 224	Measured as count of events.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent serious adverse events (TESAEs) Tidsramme: Baseline (week 0), week 68 and week 224	Measured as count of events.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent hypoglycaemic episodes Tidsramme: Baseline (week 0), week 68 and week 224	Measured as count of events.	Baseline (week 0), week 68 and week 224
Change in pulse rate Tidsramme: Baseline (week 0), week 68	Measured in beats per minute (beats/min).	Baseline (week 0), week 68
Change in calcitonin Tidsramme: Baseline (week 0), week 68	Measured in nanograms per liter (ng/L).	Baseline (week 0), week 68
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state Tidsramme: Baseline (week 0), week 68	Measured in liters per hour (L/h).	Baseline (week 0), week 68
Average concentration (Cavg) of semaglutide and cagrilintide at steady state Tidsramme: Baseline (week 0), week 68	Measured in nanomoles per liter (nmol/L).	Baseline (week 0), week 68
Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide Tidsramme: Baseline (week 0), week 68	Measured in hours nanomoles per liter (h·nmol/L).	Baseline (week 0), week 68

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2026

Primær færdiggørelse (Anslået)

20. marts 2030

Studieafslutning (Anslået)

20. september 2033

Datoer for studieregistrering

Først indsendt

19. november 2025

Først indsendt, der opfyldte QC-kriterier

19. november 2025

Først opslået (Faktiske)

28. november 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NN9838-4968
U1111-1299-4751 (Anden identifikator: World Health Organization (WHO))
2023-509176-42 (Anden identifikator: European Medical Agency (EMA))
2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Et forskningsstudie om, hvor godt Cagrilintid og CagriSema virker hos børn og unge med overvægt

Effekt, sikkerhed og farmakokinetik for Cagrilintide s.c. 2,4 mg som monoterapi og i kombination med Semaglutide s.c. 2,4 mg (CagriSema) en gang ugentligt til vægtstyring hos børn og unge med overvægt eller fedme

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt