Tutkimus siitä, kuinka hyvin cagrilintidi ja CagriSema tehoavat ylipainoisiin lapsiin ja nuoriin
Cagrilintide s.c. 2.4 mg:n tehokkuus, turvallisuus ja farmakokinetiikka yksilölääkityksenä ja yhdistettynä semaglutidin s.c. 2.4 mg:n (CagriSema) kanssa kerran viikossa painonhallintaan ylipainoisten tai lihavien lasten ja nuorten keskuudessa
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Novo Nordisk
- Puhelinnumero: (+1) 866-867-7178
- Sähköposti: clinicaltrials@novonordisk.com
Opiskelupaikat
-
-
-
's-Hertogenbosch, Alankomaat, 5223 GZ
- Ei vielä rekrytointia
- Jeroen Bosch Zkh
-
Amersfoort, Alankomaat, 3813 TZ
- Valmis
- Meander MC
-
-
-
-
New South Wales
-
Westmead, New South Wales, Australia, 2145
- Rekrytointi
- The Children's Hospital at Westmead - Clinical Research Centre
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- Rekrytointi
- Queensland Children's Hospital
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Rekrytointi
- Perth Children's Hospital
-
-
-
-
-
Brussels, Belgia, 1090
- Rekrytointi
- UZ Brussel - Universitair Ziekenhuis Brussel
-
Edegem, Belgia, 2650
- Rekrytointi
- UZA - Universitair Ziekenhuis Antwerpen
-
-
-
-
-
Plovdiv, Bulgaria, 4001
- Rekrytointi
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
-
Sofia, Bulgaria, 1618
- Ei vielä rekrytointia
- Medical center Children's Health EOOD
-
Sofia, Bulgaria, 1606
- Rekrytointi
- SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
-
Varna, Bulgaria, 9010
- Rekrytointi
- UMHAT Sveta Marina EAD, First Pediatric Clinic
-
-
-
-
-
Barcelona, Espanja, 08035
- Ei vielä rekrytointia
- Hosp. Vall d'Hebrón_Endocrinología pediatríca
-
Esplugues de Llobregat, Espanja, 08950
- Ei vielä rekrytointia
- Hospital Sant Joan de Déu
-
Seville, Espanja, 41013
- Ei vielä rekrytointia
- Hospital Universitario Virgen del Rocío
-
-
-
-
-
Kolhāpur, Intia, 416008
- Ei vielä rekrytointia
- Excel Endocrine Centre
-
New Delhi, Intia, 110029
- Ei vielä rekrytointia
- All India Institute of Medical Sciences (AIIMS)
-
-
Andhra Pradesh
-
Guntur, Andhra Pradesh, Intia, 522001
- Ei vielä rekrytointia
- Endolife Specialty Hospitals
-
-
Gujarat
-
Surat, Gujarat, Intia, 395009
- Ei vielä rekrytointia
- BAPS Pramukh Swami Hospital
-
-
Karnataka
-
Bangalore, Karnataka, Intia, 560011
- Ei vielä rekrytointia
- Indira Gandhi Institute of child health
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Intia, 110060
- Ei vielä rekrytointia
- Sir Ganga Ram Hospital
-
-
New Delhi
-
Delhi, New Delhi, Intia, 110002
- Ei vielä rekrytointia
- Maulana Azad Medical College
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, Intia, 208006
- Ei vielä rekrytointia
- Regency Hospital
-
-
West Bengal
-
Kolkata, West Bengal, Intia, 700017
- Ei vielä rekrytointia
- Institute of Child Health
-
-
-
-
-
Haifa, Israel, 31096
- Ei vielä rekrytointia
- Rambam MC - Department of Pediatrics A
-
Jerusalem, Israel, 9103102
- Ei vielä rekrytointia
- Shaare Zedek MC - Endocrinology Department
-
Petah Tikva, Israel, 49202
- Ei vielä rekrytointia
- Schneider MC - Endrocrinology and Diabetes
-
Tsrifin, Israel, 7033001
- Ei vielä rekrytointia
- Shamir MC - Pediatric and Adolescents Endocrinology unit
-
-
-
-
-
Trieste, Italia, 34137
- Ei vielä rekrytointia
- IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
-
-
Lombardy
-
Milan, Lombardy, Italia, 20122
- Ei vielä rekrytointia
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
-
-
Piedmont
-
Novara, Piedmont, Italia, 28100
- Ei vielä rekrytointia
- AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
-
-
Veneto
-
Verona, Veneto, Italia, 37126
- Ei vielä rekrytointia
- A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
-
-
-
-
-
Innsbruck, Itävalta, 6020
- Rekrytointi
- Universitätsklinik Kinder-Jugendheilkunde Innsbruck
-
Salzburg, Itävalta, 5020
- Rekrytointi
- Universitätsklinik für Kinder und Jugendheilkunde Haus E
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kiina, 100045
- Ei vielä rekrytointia
- Beijing Children's Hospital, Capital Medical University
-
Beijing, Beijing Municipality, Kiina, 100020
- Rekrytointi
- Capital Center for Children's Health, Capital Medical University-Endocrinology
-
-
Henan
-
Zhengzhou, Henan, Kiina, 450018
- Rekrytointi
- Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
-
-
Hubei
-
Wuhan, Hubei, Kiina, 430019
- Rekrytointi
- Wuhan Children Hospital-Endocrine Genetics and Metabolism
-
Wuhan, Hubei, Kiina, 430030
- Rekrytointi
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
-
-
Jilin
-
Changchun, Jilin, Kiina, 130021
- Ei vielä rekrytointia
- The First Bethune Hospital of Jilin University-Pediatric
-
-
Shandong
-
Jinan, Shandong, Kiina, 250098
- Rekrytointi
- Shandong Provincial Hospital-Pediatric
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kiina, 201102
- Rekrytointi
- Children's Hospital of Fudan University-Endocrinology and Metabolism
-
-
Sichuan
-
Chengdu, Sichuan, Kiina, 610031
- Rekrytointi
- Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
-
-
-
-
-
Bogotá, Kolumbia, 110111
- Ei vielä rekrytointia
- Fundación Santa Fe de Bogotá
-
-
Antioquia
-
Medellín, Antioquia, Kolumbia, 05001
- Ei vielä rekrytointia
- Servicios de Salud Ips Suramericana S.A.S.
-
-
-
-
-
Rijeka, Kroatia, 51 000
- Ei vielä rekrytointia
- Clinical Hospital Centre Rijeka_Pediatric
-
Zagreb, Kroatia, 10 000
- Ei vielä rekrytointia
- KBC "Sestre Milosrdnice"
-
Zagreb, Kroatia, 10000
- Ei vielä rekrytointia
- Klinika Za Djecje Bolesti Zagreb_Endocrinology
-
-
-
-
Kuala Lumpur
-
Kampung Baru, Kuala Lumpur, Malesia, 50300
- Ei vielä rekrytointia
- Hospital Tunku Azizah
-
Lembah Pantai, Kuala Lumpur, Malesia, 59100
- Rekrytointi
- University Malaya Medical Centre
-
-
Sarawak
-
Sibu, Sarawak, Malesia, 96000
- Rekrytointi
- Hospital Sibu
-
-
-
-
-
Puebla City, Meksiko, 72190
- Ei vielä rekrytointia
- Consultorio de Endocrinología y Pediatría
-
-
Nuevo León
-
Monterrey, Nuevo León, Meksiko, 64060
- Ei vielä rekrytointia
- CHRISTUS - Latam Hub Excellence and Innovation Center
-
Monterrey, Nuevo León, Meksiko, 64310
- Ei vielä rekrytointia
- IECSI Centro de Investigación Clínica
-
-
-
-
-
Porto, Portugali, 4050-651
- Ei vielä rekrytointia
- ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
-
Porto, Portugali, 4100-180
- Ei vielä rekrytointia
- CUF Porto_Serviço de Pediatria
-
Vila Nova de Gaia, Portugali, 4434-502
- Ei vielä rekrytointia
- ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
-
-
-
-
-
Dziekanów Leśny, Puola, 05-092
- Ei vielä rekrytointia
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
-
Opole, Puola, 45-401
- Ei vielä rekrytointia
- Uniwersytecki Szpital Kliniczny w Opolu
-
Rzeszów, Puola, 35-301
- Ei vielä rekrytointia
- Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
-
Zabrze, Puola, 41-800
- Ei vielä rekrytointia
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
-
-
-
-
Baia Mare, Romania, 430031
- Ei vielä rekrytointia
- Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
-
Bucharest, Romania, 041451
- Rekrytointi
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
-
Bucharest, Romania, 010073
- Rekrytointi
- Kilostop Junior SRL
-
Timișoara, Romania, 300226
- Rekrytointi
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
-
-
-
-
-
Umeå, Ruotsi, 907 37
- Ei vielä rekrytointia
- Barn och ungdomscentrum Västerbotten - NU
-
Uppsala, Ruotsi, 75185
- Ei vielä rekrytointia
- Akademiska barnsjukhuset - klinisk forskningsmottagning
-
-
-
-
-
Belgrade, Serbia, 11000
- Rekrytointi
- University Children's Hospital Tirsova
-
Belgrade, Serbia, 11070
- Rekrytointi
- Institute for Mother and Child Health Care of Serbia
-
Novi Sad, Serbia, 21000
- Rekrytointi
- Institute for Health Care of Children and Adolescents
-
-
-
-
-
Bratislava, Slovakia, 833 40
- Ei vielä rekrytointia
- Narodny Ustav Detskych Chorob
-
Košice, Slovakia, 040 01
- Rekrytointi
- Detska Fakultna nemocnica Kosice
-
Poprad, Slovakia, 058 45
- Ei vielä rekrytointia
- Nemocnica Poprad, a.s.
-
Ľubochňa, Slovakia, 03491
- Rekrytointi
- Narodny Endokrinologicky a diabetologicky ustav
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Rekrytointi
- Chang Gung Memorial Hospital - Kaohsiung Branch
-
Taichung, Taiwan, 402
- Rekrytointi
- Chung Shan Medical University Hospital
-
Taipei, Taiwan, 104
- Rekrytointi
- Taipei Mackay Children's Hospital
-
Taoyuan, Taiwan, 333
- Rekrytointi
- Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
-
-
-
-
-
Aalborg, Tanska, 9000
- Ei vielä rekrytointia
- Aalborg Universitetshospital - Børne og Ungeafdelingen
-
Holbæk, Tanska, 4300
- Rekrytointi
- Holbæk Sygehus - Børne- og Ungeafdelingen
-
-
-
-
-
Bangkok, Thaimaa, 10300
- Rekrytointi
- King Chulalongkorn Memorial Hospital_Ped-Nutrition
-
Pathum Thani, Thaimaa, 12120
- Rekrytointi
- Thammasat Hospital_CRC
-
-
-
-
-
Budapest, Unkari, 1083
- Ei vielä rekrytointia
- Semmelweis Egyetem ÁOK
-
Budapest, Unkari, 1023
- Rekrytointi
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
-
Szeged, Unkari, 6720
- Ei vielä rekrytointia
- Szegedi Tudományegyetem Gyermekgyógyászati Klinika
-
-
-
-
-
Birmingham, Yhdistynyt kuningaskunta, B4 6NH
- Rekrytointi
- Birmingham Children's Hospital
-
Liverpool, Yhdistynyt kuningaskunta, L12 2AP
- Rekrytointi
- Alder Hey Children's Hospital
-
London, Yhdistynyt kuningaskunta, NW1 1BU
- Rekrytointi
- University College Hospital - Paediatric Services
-
-
-
-
California
-
Escondido, California, Yhdysvallat, 92025
- Rekrytointi
- Neighborhood Healthcare
-
-
Florida
-
Hollywood, Florida, Yhdysvallat, 33024
- Rekrytointi
- Encore Medical Research LLC
-
Jacksonville, Florida, Yhdysvallat, 32216
- Rekrytointi
- Jacksonville Ctr for Clin Res
-
Weston, Florida, Yhdysvallat, 33331
- Rekrytointi
- Encore Medical Research of Weston
-
-
Georgia
-
Atlanta, Georgia, Yhdysvallat, 30329
- Rekrytointi
- Children's Healthcare Atlanta
-
Columbus, Georgia, Yhdysvallat, 31904
- Rekrytointi
- Columbus Research Foundation
-
Decatur, Georgia, Yhdysvallat, 30030
- Rekrytointi
- Accel Research Sites-NeuroStudies
-
Snellville, Georgia, Yhdysvallat, 30078
- Rekrytointi
- Eastside Bariatric and Gen Surg
-
-
Idaho
-
Meridian, Idaho, Yhdysvallat, 83646
- Rekrytointi
- Solaris Clinical Research
-
-
Indiana
-
Indianapolis, Indiana, Yhdysvallat, 46202
- Rekrytointi
- IU Health - Riley Physicians Endo-Diab
-
-
Kansas
-
Topeka, Kansas, Yhdysvallat, 66606
- Rekrytointi
- Cotton O'Neil Clinical Research Center
-
-
Louisiana
-
Baton Rouge, Louisiana, Yhdysvallat, 70808-4124
- Rekrytointi
- Pennington Biomed Res Ctr
-
-
Maryland
-
Baltimore, Maryland, Yhdysvallat, 21229
- Rekrytointi
- Barry J. Reiner, MD LLC
-
-
Minnesota
-
Minneapolis, Minnesota, Yhdysvallat, 55455
- Rekrytointi
- University of Minnesota
-
Richfield, Minnesota, Yhdysvallat, 55423
- Rekrytointi
- Synexus Clinical Research US-MN
-
-
New York
-
Buffalo, New York, Yhdysvallat, 14203
- Ei vielä rekrytointia
- UBMD Physicians Group - Pediatrics - Conventus
-
Syracuse, New York, Yhdysvallat, 13210
- Rekrytointi
- SUNY Upstate Medical Univ - Syracuse
-
The Bronx, New York, Yhdysvallat, 10467
- Ei vielä rekrytointia
- Advantage Clinical Trials
-
-
North Dakota
-
Fargo, North Dakota, Yhdysvallat, 58104
- Rekrytointi
- Valley Weight Loss Clinic
-
-
Ohio
-
Columbus, Ohio, Yhdysvallat, 43213
- Rekrytointi
- Centricity Research - Ohio
-
Dayton, Ohio, Yhdysvallat, 45429
- Rekrytointi
- PriMed Clinical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 73104
- Ei vielä rekrytointia
- Children's Physicians OU
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15224
- Ei vielä rekrytointia
- UPMC Child Hosp-Pittsburgh
-
-
South Carolina
-
Greenville, South Carolina, Yhdysvallat, 29615
- Ei vielä rekrytointia
- Prisma Health-Ped Endo
-
North Charleston, South Carolina, Yhdysvallat, 29405
- Rekrytointi
- Coastal Carolina Research Ctr
-
-
South Dakota
-
Rapid City, South Dakota, Yhdysvallat, 57701
- Ei vielä rekrytointia
- Monument Health Clinical Rsrch
-
-
Tennessee
-
Memphis, Tennessee, Yhdysvallat, 38115
- Rekrytointi
- LifeDoc Health
-
-
Texas
-
Houston, Texas, Yhdysvallat, 77065
- Rekrytointi
- DM Clinical
-
San Antonio, Texas, Yhdysvallat, 78215
- Rekrytointi
- The Texas Liver Institute
-
San Antonio, Texas, Yhdysvallat, 78207
- Ei vielä rekrytointia
- DM Clinical
-
San Antonio, Texas, Yhdysvallat, 78222
- Rekrytointi
- Pinnacle Clinical Research
-
Shavano Park, Texas, Yhdysvallat, 78231
- Rekrytointi
- Consano Clin Res-Shavano Park
-
Weslaco, Texas, Yhdysvallat, 78596
- Rekrytointi
- Texas Valley Clinical Research
-
-
Utah
-
Layton, Utah, Yhdysvallat, 84041
- Rekrytointi
- AMR Clinical
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
Participants will receive cagrilintide subcutaneously. Participants will receive semaglutide subcutaneously. Participants will receive placebo matched to cagrilintide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
|
Kokeellinen: 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. |
Participants will receive semaglutide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
|
Kokeellinen: 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. |
Participants will receive cagrilintide subcutaneously. 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. |
Participants will receive placebo matched to cagrilintide subcutaneously. Participants will receive placebo matched to semaglutide subcutaneously. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Relative change in body mass index (BMI)
Aikaikkuna: Baseline (week 0), week 68
|
Measured in percentage (%). |
Baseline (week 0), week 68
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Relative change in body weight
Aikaikkuna: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Change in BMI Standard Deviation Score (SDS)
Aikaikkuna: Baseline (week 0), week 68
|
Measured as SDS score. |
Baseline (week 0), week 68
|
|
Relative change in BMI
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Number of participants who achieved normal BMI
Aikaikkuna: 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
Aikaikkuna: Baseline (week 0), week 68
|
Measured as count of participants. |
Baseline (week 0), week 68
|
|
Change in waist circumference
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: Baseline (week 0), week 68
|
Measured in kilograms (kg). |
Baseline (week 0), week 68
|
|
Relative to baseline change in total fat mass by DXA
Aikaikkuna: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in total fat mass by DXA
Aikaikkuna: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in visceral fat mass by DXA
Aikaikkuna: Baseline (week 0), week 68
|
Measured in kg. |
Baseline (week 0), week 68
|
|
Relative to baseline change in visceral fat mass by DXA
Aikaikkuna: Baseline (week 0), week 68
|
Measured in %. |
Baseline (week 0), week 68
|
|
Relative to total body mass change in visceral fat mass by DXA
Aikaikkuna: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Absolute change in lean body mass by DXA
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Baseline (week 0), week 68
|
Measured in % points. |
Baseline (week 0), week 68
|
|
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Aikaikkuna: Baseline (week 0), week 68
|
Measured as ratio. |
Baseline (week 0), week 68
|
|
Ratio to baseline in lipids: Total cholesterol
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline (week 0), week 68 and week 224
|
Measured as ratio. |
Baseline (week 0), week 68 and week 224
|
|
Change in Alanine Transaminase (ALT)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: Baseline (week 0), week 68
|
Measured in mmol/L. |
Baseline (week 0), week 68
|
|
Change in FPG (milligrams per deciliter [mg/dL])
Aikaikkuna: Baseline (week 0), week 68
|
Measured in mg/dL. |
Baseline (week 0), week 68
|
|
Ratio to baseline in fasting serum insulin
Aikaikkuna: 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
Aikaikkuna: 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 %
Aikaikkuna: 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%
Aikaikkuna: 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%
Aikaikkuna: At week 68
|
Measured as count of participants. |
At week 68
|
|
Number of participants taking glucose lowering medication at baseline, stop or decrease
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline (week 0), week 68
|
Measured in beats per minute (beats/min). |
Baseline (week 0), week 68
|
|
Change in calcitonin
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline (week 0), week 68
|
Measured in hours nanomoles per liter (h·nmol/L). |
Baseline (week 0), week 68
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NN9838-4968
- U1111-1299-4751 (Muu tunniste: World Health Organization (WHO))
- 2023-509176-42 (Muu tunniste: European Medical Agency (EMA))
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .