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一项关于卡格利肽和卡格利塞玛对超重儿童和青少年疗效的研究

2026年9月28日更新者：Novo Nordisk A/S

Cagrilintide 皮下注射 2.4 mg 作为单药治疗及与司美格鲁肽皮下注射 2.4 mg 联合治疗（CagriSema）每周一次用于超重或肥胖儿童和青少年体重管理的疗效、安全性和药代动力学

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

460

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Novo Nordisk
电话号码：(+1) 866-867-7178
邮箱：clinicaltrials@novonordisk.com

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：Cagrilintide Participants will receive cagrilintide subcutaneously. 药品：Semaglutide Participants will receive semaglutide subcutaneously. 药品：Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. 药品：Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
实验性的：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.	药品：Semaglutide Participants will receive semaglutide subcutaneously. 药品：Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
实验性的：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.	药品：Cagrilintide Participants will receive cagrilintide subcutaneously. 药品：Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously.
安慰剂比较：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.	药品：Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. 药品：Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Relative change in body mass index (BMI) 大体时间：Baseline (week 0), week 68	Measured in percentage (%).	Baseline (week 0), week 68

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novo Nordisk A/S

调查人员

研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月8日

初级完成 (估计的)

2030年3月20日

研究完成 (估计的)

2033年9月20日

研究注册日期

首次提交

2025年11月19日

首先提交符合 QC 标准的

2025年11月19日

首次发布 (实际的)

2025年11月28日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

一项关于卡格利肽和卡格利塞玛对超重儿童和青少年疗效的研究

Cagrilintide 皮下注射 2.4 mg 作为单药治疗及与司美格鲁肽 皮下注射 2.4 mg 联合治疗（CagriSema）每周一次用于超重或肥胖儿童和青少年体重管理的疗效、安全性和药代动力学

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

Cagrilintide 皮下注射 2.4 mg 作为单药治疗及与司美格鲁肽皮下注射 2.4 mg 联合治疗（CagriSema）每周一次用于超重或肥胖儿童和青少年体重管理的疗效、安全性和药代动力学