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En forskningsstudie om hur väl cagrilintid och CagriSema fungerar hos barn och ungdomar med övervikt

28 september 2026 uppdaterad av: Novo Nordisk A/S

Effekt, säkerhet och farmakokinetik hos Cagrilintide s.c. 2,4 mg som monoterapi och i kombination med Semaglutide s.c. 2,4 mg (CagriSema) en gång i veckan för viktkontroll hos barn och ungdomar med övervikt eller fetma

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

460

Fas

Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

8 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Fyrdubbla

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Experimentell: 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.	Läkemedel: Cagrilintide Participants will receive cagrilintide subcutaneously. Läkemedel: Semaglutide Participants will receive semaglutide subcutaneously. Läkemedel: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Läkemedel: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Experimentell: 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.	Läkemedel: Semaglutide Participants will receive semaglutide subcutaneously. Läkemedel: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Experimentell: 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.	Läkemedel: Cagrilintide Participants will receive cagrilintide subcutaneously. Läkemedel: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo-jämförare: 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.	Läkemedel: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Läkemedel: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Relative change in body mass index (BMI) Tidsram: Baseline (week 0), week 68	Measured in percentage (%).	Baseline (week 0), week 68

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novo Nordisk A/S

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 januari 2026

Primärt slutförande (Beräknad)

20 mars 2030

Avslutad studie (Beräknad)

20 september 2033

Studieregistreringsdatum

Först inskickad

19 november 2025

Först inskickad som uppfyllde QC-kriterierna

19 november 2025

Första postat (Faktisk)

28 november 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

En forskningsstudie om hur väl cagrilintid och CagriSema fungerar hos barn och ungdomar med övervikt

Effekt, säkerhet och farmakokinetik hos Cagrilintide s.c. 2,4 mg som monoterapi och i kombination med Semaglutide s.c. 2,4 mg (CagriSema) en gång i veckan för viktkontroll hos barn och ungdomar med övervikt eller fetma

Studieöversikt

Status

Betingelser

Intervention / Behandling

Studietyp

Inskrivning (Beräknad)

Fas

Kontakter och platser

Studiekontakt

Studieorter

Deltagandekriterier

Urvalskriterier

Åldrar som är berättigade till studier

Tar emot friska volontärer

Kön som är behöriga för studier

Beskrivning

Studieplan

Hur är studien utformad?

Designdetaljer

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm

Intervention / Behandling

Vad mäter studien?

Primära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Sekundära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Samarbetspartners och utredare

Sponsor

Utredare

Studieavstämningsdatum

Studera stora datum

Studiestart (Faktisk)

Primärt slutförande (Beräknad)

Avslutad studie (Beräknad)

Studieregistreringsdatum

Först inskickad

Först inskickad som uppfyllde QC-kriterierna

Första postat (Faktisk)

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

Senast verifierad

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt