Actively Recruiting
Efficacy, Safety and Pharmacokinetics of Cagrilintide and Semaglutide (CagriSema) Once Weekly for Weight Management in Children and Adolescents With Overweight or Obesity
Led by Novo Nordisk A/S · Updated on 2026-04-02
460
Participants Needed
119
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of CagriSema, cagrilintide, and semaglutide on weight loss in children and adolescents with excess body weight. This phase 3 study aims to compare these treatments against a placebo to see how well they help manage overweight or obesity in this younger population. The study is sponsored by Novo Nordisk A/S and involves participants aged 8 to under 18 years who meet specific BMI and health criteria. Participants are randomly assigned to receive one of four treatments: CagriSema (a combination of cagrilintide and semaglutide), cagrilintide alone, semaglutide alone, or a placebo. All treatments are given as once-weekly injections under the skin, starting with a dose escalation period of up to 16 weeks, followed by maintenance dosing for 52 weeks in the main study. Those in the extension study continue with CagriSema or cagrilintide for up to 156 weeks, while participants who received semaglutide do not enter the extension phase. During the study, participants will have their body mass index (BMI) and body weight monitored regularly, with the primary outcome measured as the relative change in BMI from the start to week 68. Additional assessments include changes in body composition through scans like DXA and MRI, metabolic markers, blood pressure, and quality of life questionnaires. Safety is closely monitored throughout, with the total participation lasting about 1 year and 6 months for the main study and up to nearly 5 years if including the extension phase.
CONDITIONS
Brief Title
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent(s) or legal representative must give informed consent and child must give assent before any study activities.
- Male or female participants aged 8 to less than 18 years at consent.
- BMI at screening at or above the 95th percentile for children aged 8 to under 12 years.
- For adolescents aged 12 to under 18 years, BMI at or above the 95th percentile, or at least the 85th percentile with at least one obesity-related complication such as type 2 diabetes, hypertension, dyslipidaemia, or obstructive sleep apnea.
- Laboratory tests within normal sex- and age-specific ranges for calcium, phosphate, alkaline phosphatase, and parathyroid hormone.
- History of at least one unsuccessful attempt to lose weight with a structured diet and exercise program lasting at least 3 months.
- Body weight greater than 45 kilograms at screening.
- For participants with type 2 diabetes, HbA1c less than or equal to 10.0%, stable treatment with lifestyle intervention or metformin for at least 56 days before screening.
You will not qualify if you...
- Use of any medication prescribed for obesity or weight management within 90 days before screening.
- Previous or planned obesity surgery or weight loss device during the study, except certain procedures performed over 1 year before screening.
- Uncontrolled thyroid disease.
- Endocrine, hypothalamic, or syndromic obesity.
- Body weight change greater than 5% within 90 days before screening.
- Type 1 diabetes or monogenic diabetes.
- For participants without type 2 diabetes, HbA1c greater than or equal to 6.5% or use of glucose-lowering agents within 90 days before screening.
- For participants with type 2 diabetes, hypoglycaemic unawareness, recent severe hypoglycaemic episodes, certain diabetes-related antibodies, use of diabetes medications other than those allowed, or unstable diabetic retinopathy or maculopathy within 90 days before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 68 weeks including a main phase of up to 16 weeks and a maintenance phase for 52 weeks
Participants receive once weekly subcutaneous doses of study drugs or placebo in a dose escalation regimen during the main phase, followed by maintenance dosing. Participants receive treatment for weight management.
Weekly visits during dose escalation phase (up to 16 weeks) and regular visits during maintenance phase up to week 68
Duration - Up to 156 weeks for experimental arms and up to 140 weeks for placebo arm
Participants continue to receive the same dose or maximum tolerated dose in an open-label extension phase to monitor long-term safety and efficacy.
Regular visits during the open-label extension phase
Trial Site Locations
Total: 119 locations
1
Neighborhood Healthcare
Escondido, California, United States, 92025
Not Yet Recruiting
2
Encore Medical Research LLC
Hollywood, Florida, United States, 33024
Actively Recruiting
3
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States, 32216
Not Yet Recruiting
4
Encore Medical Research of Weston
Weston, Florida, United States, 33331
Actively Recruiting
5
Children's Healthcare Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Columbus Research Foundation
Columbus, Georgia, United States, 31904
Actively Recruiting
7
Accel Research Sites-NeuroStudies
Decatur, Georgia, United States, 30030
Actively Recruiting
8
Eastside Bariatric and Gen Surg
Snellville, Georgia, United States, 30078
Actively Recruiting
9
Solaris Clinical Research
Meridian, Idaho, United States, 83646
Not Yet Recruiting
10
IU Health - Riley Physicians Endo-Diab
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
Not Yet Recruiting
12
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States, 70808-4124
Actively Recruiting
13
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States, 21229
Not Yet Recruiting
14
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
AES Minneapolis DRS
Richfield, Minnesota, United States, 55423
Not Yet Recruiting
16
UBMD Physicians Group - Pediatrics - Conventus
Buffalo, New York, United States, 15203
Not Yet Recruiting
17
SUNY Upstate Medical Univ - Syracuse
Syracuse, New York, United States, 13210
Not Yet Recruiting
18
Advantage Clinical Trials
The Bronx, New York, United States, 10467
Not Yet Recruiting
19
Valley Weight Loss Clinic
Fargo, North Dakota, United States, 58104
Not Yet Recruiting
20
Centricity Research - Ohio
Columbus, Ohio, United States, 43213
Not Yet Recruiting
21
PriMed Clinical Research
Dayton, Ohio, United States, 45429
Not Yet Recruiting
22
Children's Physicians OU
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
23
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
24
Prisma Health-Ped Endo
Greenville, South Carolina, United States, 29615
Not Yet Recruiting
25
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States, 29405
Not Yet Recruiting
26
Monument Health Clinical Rsrch
Rapid City, South Dakota, United States, 57701
Not Yet Recruiting
27
LifeDoc Health
Memphis, Tennessee, United States, 38115
Not Yet Recruiting
28
DM Clinical
Houston, Texas, United States, 77065
Actively Recruiting
29
DM Clinical
San Antonio, Texas, United States, 78207
Not Yet Recruiting
30
The Texas Liver Institute
San Antonio, Texas, United States, 78215
Not Yet Recruiting
31
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Not Yet Recruiting
32
Consano Clin Res-Shavano Park
Shavano Park, Texas, United States, 78231
Not Yet Recruiting
33
Texas Valley Clinical Research
Weslaco, Texas, United States, 78596
Not Yet Recruiting
34
Wee Care Pediatrics
Syracuse, Utah, United States, 84075
Not Yet Recruiting
35
The Children's Hospital at Westmead - Clinical Research Centre
Westmead, New South Wales, Australia, 2145
Actively Recruiting
36
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
37
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
38
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, Austria, 6020
Not Yet Recruiting
39
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, Austria, 5020
Not Yet Recruiting
40
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
41
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem, Belgium, 2650
Not Yet Recruiting
42
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, Bulgaria, 4002
Not Yet Recruiting
43
SHATPD - Prof. Ivan Mitev EAD
Sofia, Bulgaria, 1606
Not Yet Recruiting
44
Medical center Children's Health EOOD
Sofia, Bulgaria, 1618
Not Yet Recruiting
45
UMHAT Sveta Marina EAD, First Pediatric Clinic
Varna, Bulgaria, 9010
Not Yet Recruiting
46
Capital Center for Children's Health, Capital Medical University
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
47
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Not Yet Recruiting
48
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China, 450018
Not Yet Recruiting
49
Wuhan Children Hospital
Wuhan, Hubei, China, 430019
Not Yet Recruiting
50
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
51
The First Bethune Hospital of Jilin University-Pediatric
Changchun, Jilin, China, 130021
Not Yet Recruiting
52
Shandong Provincial Hospital-Pediatric
Jinan, Shandong, China, 250098
Not Yet Recruiting
53
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Not Yet Recruiting
54
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China, 610031
Not Yet Recruiting
55
Servicios de Salud Ips Suramericana S.A.S.
Medellín, Antioquia, Colombia, 05001
Not Yet Recruiting
56
Fundación Santa Fe de Bogotá
Bogotá, Colombia, 110111
Not Yet Recruiting
57
Clinical Hospital Centre Rijeka_Pediatric
Rijeka, Croatia, 51 000
Not Yet Recruiting
58
KBC "Sestre Milosrdnice"
Zagreb, Croatia, 10 000
Not Yet Recruiting
59
Klinika Za Djecje Bolesti Zagreb_Endocrinology
Zagreb, Croatia, 10000
Not Yet Recruiting
60
Aalborg Universitetshospital - Børne og Ungeafdelingen
Aalborg, Denmark, 9000
Not Yet Recruiting
61
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, Denmark, 4300
Not Yet Recruiting
62
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
Budapest, Hungary, 1023
Not Yet Recruiting
63
Semmelweis Egyetem ÁOK
Budapest, Hungary, 1083
Not Yet Recruiting
64
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
Szeged, Hungary, 6720
Not Yet Recruiting
65
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India, 522001
Not Yet Recruiting
66
BAPS Pramukh Swami Hospital
Surat, Gujarat, India, 395009
Not Yet Recruiting
67
Indira Gandhi Institute of child health
Bangalore, Karnataka, India, 560011
Not Yet Recruiting
68
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Not Yet Recruiting
69
Maulana Azad Medical College
Delhi, New Delhi, India, 110002
Not Yet Recruiting
70
Regency Hospital
Kanpur, Uttar Pradesh, India, 208006
Not Yet Recruiting
71
Institute of Child Health
Kolkata, West Bengal, India, 700017
Not Yet Recruiting
72
Excel Endocrine Centre
Kolhāpur, India, 416008
Not Yet Recruiting
73
All India Institute of Medical Sciences (AIIMS)
New Delhi, India, 110029
Not Yet Recruiting
74
Rambam MC - Department of Pediatrics A
Haifa, Israel, 31096
Not Yet Recruiting
75
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, Israel, 49202
Not Yet Recruiting
76
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin, Israel, 7033001
Not Yet Recruiting
77
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
Milan, Lombardy, Italy, 20122
Not Yet Recruiting
78
AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
Novara, Piedmont, Italy, 28100
Not Yet Recruiting
79
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, Italy, 34137
Not Yet Recruiting
80
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, Italy, 37126
Not Yet Recruiting
81
Hospital Tunku Azizah
Kampung Baru, Kuala Lumpur, Malaysia, 50300
Not Yet Recruiting
82
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Not Yet Recruiting
83
Hospital Sibu
Sibu, Sarawak, Malaysia, 96000
Not Yet Recruiting
84
CHRISTUS - Latam Hub Excellence and Innovation Center
Monterrey, Nuevo León, Mexico, 64060
Not Yet Recruiting
85
IECSI Centro de Investigación Clínica
Monterrey, Nuevo León, Mexico, 64310
Not Yet Recruiting
86
Consultorio de Endocrinología y Pediatría
Puebla City, Mexico, 72190
Not Yet Recruiting
87
Jeroen Bosch Zkh
's-Hertogenbosch, Netherlands, 5223 GZ
Not Yet Recruiting
88
Meander MC
Amersfoort, Netherlands, 3813 TZ
Completed
89
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
Dziekanów Leśny, Poland, 05-092
Not Yet Recruiting
90
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland, 45-401
Not Yet Recruiting
91
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, Poland, 35-301
Not Yet Recruiting
92
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, Poland, 41-800
Not Yet Recruiting
93
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, Portugal, 4050-342
Not Yet Recruiting
94
Hospital CUF Porto S.A.
Porto, Portugal, 4100-180
Not Yet Recruiting
95
ULS De Gaia/Espinho E.P.E. - Hospital Eduardo Santos Silva
Vila Nova de Gaia, Portugal, 4434-502
Not Yet Recruiting
96
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, Romania, 430031
Not Yet Recruiting
97
Kilostop Junior SRL
Bucharest, Romania, 010073
Not Yet Recruiting
98
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, Romania, 041451
Not Yet Recruiting
99
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, Romania, 300226
Not Yet Recruiting
100
University Children's Hospital Tirsova
Belgrade, Serbia, 11000
Not Yet Recruiting
101
Institute for Mother and Child Health Care of Serbia
Belgrade, Serbia, 11070
Not Yet Recruiting
102
Institute for Health Care of Children and Adolescents
Novi Sad, Serbia, 21000
Not Yet Recruiting
103
Narodny Ustav Detskych Chorob
Bratislava, Slovakia, 833 40
Not Yet Recruiting
104
Detska Fakultna nemocnica Kosice
Košice, Slovakia, 040 01
Not Yet Recruiting
105
Narodny Endokrinologicky a diabetologicky ustav
Ľubochňa, Slovakia, 03491
Not Yet Recruiting
106
Hospital Vall d'Hebrón_Endocrinología pediatríca
Barcelona, Spain, 08035
Not Yet Recruiting
107
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Not Yet Recruiting
108
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Not Yet Recruiting
109
Barn och ungdomscentrum Västerbotten - NU
Umeå, Sweden, 907 37
Not Yet Recruiting
110
Uppsala universitetssjukhus
Uppsala, Sweden, 75185
Not Yet Recruiting
111
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, Taiwan, 833
Not Yet Recruiting
112
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Not Yet Recruiting
113
Taipei Mackay Children's Hospital
Taipei, Taiwan, 104
Not Yet Recruiting
114
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
Taoyuan, Taiwan, 333
Not Yet Recruiting
115
King Chulalongkorn Memorial Hospital_Ped-Nutrition
Bangkok, Thailand, 10300
Not Yet Recruiting
116
Thammasat Hospital_CRC
Pathum Thani, Thailand, 12120
Not Yet Recruiting
117
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
118
Alder Hey Children's Hospital
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
119
University College Hospital - Paediatric Services
London, United Kingdom, NW1 1BU
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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