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Egy kutatási tanulmány arról, hogy mennyire jól működik a cagrilintid és a CagriSema túlsúlyos gyermekekben és serdülőkben

2026. szeptember 28. frissítette: Novo Nordisk A/S

A Cagrilintide s.c. 2,4 mg monoterápiájának és a Szemaglutiddal s.c. 2,4 mg (CagriSema) kombinációjának hatékonysága, biztonságossága és farmakokinetikája heti egyszeri alkalmazásban túlsúlyos vagy elhízott gyermekek és serdülők testsúlykezelésében

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

460

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

8 év (Gyermek, Felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Drog: Cagrilintide

Participants will receive cagrilintide subcutaneously.

Drog: Semaglutide

Participants will receive semaglutide subcutaneously.

Drog: Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

Drog: Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.
Kísérleti: 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.
Drog: Semaglutide

Participants will receive semaglutide subcutaneously.

Drog: Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.
Kísérleti: 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.
Drog: Cagrilintide

Participants will receive cagrilintide subcutaneously.

Drog: Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo Comparator: 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.
Drog: Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

Drog: Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Relative change in body mass index (BMI)
Időkeret: Baseline (week 0), week 68

Measured in percentage (%).
Baseline (week 0), week 68

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Relative change in body weight
Időkeret: Baseline (week 0), week 68

Measured in %.
Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)
Időkeret: Baseline (week 0), week 68

Measured as SDS score.
Baseline (week 0), week 68
Relative change in BMI
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: Baseline (week 0), week 68

Measured as count of participants.
Baseline (week 0), week 68
Number of participants who achieved normal BMI
Időkeret: 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
Időkeret: Baseline (week 0), week 68

Measured as count of participants.
Baseline (week 0), week 68
Change in waist circumference
Időkeret: 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
Időkeret: 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)
Időkeret: Baseline (week 0), week 68

Measured in kilograms (kg).
Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA
Időkeret: Baseline (week 0), week 68

Measured in %.
Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA
Időkeret: Baseline (week 0), week 68

Measured in % points.
Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA
Időkeret: Baseline (week 0), week 68

Measured in kg.
Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA
Időkeret: Baseline (week 0), week 68

Measured in %.
Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA
Időkeret: Baseline (week 0), week 68

Measured in % points.
Baseline (week 0), week 68
Absolute change in lean body mass by DXA
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: Baseline (week 0), week 68

Measured in % points.
Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Időkeret: Baseline (week 0), week 68

Measured as ratio.
Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline (week 0), week 68 and week 224

Measured as ratio.
Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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])
Időkeret: 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])
Időkeret: Baseline (week 0), week 68

Measured in mmol/L.
Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL])
Időkeret: Baseline (week 0), week 68

Measured in mg/dL.
Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin
Időkeret: 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
Időkeret: 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 %
Időkeret: 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%
Időkeret: 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%
Időkeret: At week 68

Measured as count of participants.
At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: Baseline (week 0), week 68

Measured in beats per minute (beats/min).
Baseline (week 0), week 68
Change in calcitonin
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline (week 0), week 68

Measured in hours nanomoles per liter (h·nmol/L).
Baseline (week 0), week 68

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Novo Nordisk A/S

Nyomozók

  • Tanulmányi igazgató: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. január 8.

Elsődleges befejezés (Becsült)

2030. március 20.

A tanulmány befejezése (Becsült)

2033. szeptember 20.

Tanulmányi regisztráció dátumai

Először benyújtva

2025. november 19.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2025. november 19.

Első közzététel (Tényleges)

2025. november 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 30.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 28.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • NN9838-4968
  • U1111-1299-4751 (Egyéb azonosító: World Health Organization (WHO))
  • 2023-509176-42 (Egyéb azonosító: European Medical Agency (EMA))
  • 2023 (Az Egyesült Államok NIH támogatása/szerződése)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Igen

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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