A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo cagrilintide; Drug: Placebo semaglutide; Drug: Semaglutide; Drug: Cagrilintide

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • The Children's Hospital at Westmead - Clinical Research Centre
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Perth Children's Hospital
• Austria
  • Innsbruck, Austria, 6020
    • Not yet recruiting
    • Universitätsklinik Kinder-Jugendheilkunde Innsbruck
  • Salzburg, Austria, 5020
    • Not yet recruiting
    • Universitätsklinik für Kinder und Jugendheilkunde Haus E
• Belgium
  • Brussels, Belgium, 1090
    • Not yet recruiting
    • UZ Brussel - Universitair Ziekenhuis Brussel
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • UZA - UZ Antwerpen - Kinderziekenhuis
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Not yet recruiting
    • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
  • Sofia, Bulgaria, 1606
    • Not yet recruiting
    • SHATPD - Prof. Ivan Mitev EAD
  • Sofia, Bulgaria, 1618
    • Not yet recruiting
    • Medical center Children's Health EOOD
  • Varna, Bulgaria, 9010
    • Not yet recruiting
    • UMHAT Sveta Marina EAD, First Pediatric Clinic
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Not yet recruiting
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100020
      • Not yet recruiting
      • Capital Center for Children's Health, Capital Medical University
  • Henan
    • Zhengzhou, Henan, China, 450018
      • Not yet recruiting
      • Henan Children's Hospital Zhengzhou Children's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Not yet recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430019
      • Not yet recruiting
      • Wuhan Children Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • The First Bethune Hospital of Jilin University-Pediatric
  • Shandong
    • Jinan, Shandong, China, 250098
      • Not yet recruiting
      • Shandong Provincial Hospital-Pediatric
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Not yet recruiting
      • Children's Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610031
      • Not yet recruiting
      • Chengdu Women's and Children's Central Hospital
• Colombia
  • Bogotá, Colombia, 110111
    • Not yet recruiting
    • Fundacion Santa Fe de Bogota
  • Antioquia
    • Medellín, Antioquia, Colombia, 05001
      • Not yet recruiting
      • Servicios de Salud Ips Suramericana S.A.S.
• Croatia
  • Rijeka, Croatia, 51 000
    • Not yet recruiting
    • Clinical Hospital Centre Rijeka_Pediatric
  • Zagreb, Croatia, 10 000
    • Not yet recruiting
    • KBC "Sestre Milosrdnice"
  • Zagreb, Croatia, 10000
    • Not yet recruiting
    • Klinika Za Djecje Bolesti Zagreb_Endocrinology
• Denmark
  • Aalborg, Denmark, 9000
    • Not yet recruiting
    • Aalborg Universitetshospital - Børne og Ungeafdelingen
  • Holbæk, Denmark, 4300
    • Not yet recruiting
    • Holbæk Sygehus - Børne- og Ungeafdelingen
• Hungary
  • Budapest, Hungary, 1023
    • Not yet recruiting
    • Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
  • Budapest, Hungary, 1083
    • Not yet recruiting
    • Semmelweis Egyetem AOK
  • Szeged, Hungary, 6720
    • Not yet recruiting
    • Szegedi Tudományegyetem Gyermekgyógyászati Klinika
• India
  • Kolhāpur, India, 416008
    • Not yet recruiting
    • Excel Endocrine Centre
  • New Delhi, India, 110029
    • Not yet recruiting
    • All India Institute Of Medical Sciences (AIIMS)
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Not yet recruiting
      • Endolife Specialty Hospitals
  • Gujarat
    • Surat, Gujarat, India, 395009
      • Not yet recruiting
      • BAPS Pramukh Swami Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560011
      • Not yet recruiting
      • Indira Gandhi Institute of child health
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110060
      • Not yet recruiting
      • Sir Ganga Ram Hospital
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Not yet recruiting
      • Maulana Azad Medical College
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208006
      • Not yet recruiting
      • Regency Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Not yet recruiting
      • Institute of Child Health
• Israel
  • Haifa, Israel, 31096
    • Not yet recruiting
    • Rambam MC - Department of Pediatrics A
  • Petah Tikva, Israel, 49202
    • Not yet recruiting
    • Schneider MC - Endrocrinology and Diabetes
  • Ẕerifin, Israel, 7033001
    • Not yet recruiting
    • Shamir MC - Pediatric and Adolescents Endocrinology unit
• Italy
  • Trieste, Italy, 34137
    • Not yet recruiting
    • IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
  • Verona, Italy, 37126
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Not yet recruiting
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Not yet recruiting
      • AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
• Malaysia
  • Kuala Lumpur
    • Kampung Baru, Kuala Lumpur, Malaysia, 50300
      • Not yet recruiting
      • Hospital Tunku Azizah
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • Not yet recruiting
      • University Malaya Medical Centre
  • Sarawak
    • Sibu, Sarawak, Malaysia, 96000
      • Not yet recruiting
      • Hospital Sibu
• Mexico
  • Puebla City, Mexico, 72190
    • Not yet recruiting
    • Consultorio de Endocrinología y Pediatría
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64060
      • Not yet recruiting
      • CHRISTUS - Latam Hub Excellence and Innovation Center
    • Monterrey, Nuevo León, Mexico, 64310
      • Not yet recruiting
      • IECSI Centro de Investigación Clínica
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Not yet recruiting
    • Jeroen Bosch Zkh
  • Amersfoort, Netherlands, 3813 TZ
    • Completed
    • Meander MC
• Poland
  • Dziekanów Leśny, Poland, 05-092
    • Not yet recruiting
    • Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
  • Opole, Poland, 45-401
    • Not yet recruiting
    • Uniwersytecki Szpital Kliniczny w Opolu
  • Rzeszów, Poland, 35-301
    • Not yet recruiting
    • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
  • Zabrze, Poland, 41-800
    • Not yet recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
• Portugal
  • Porto, Portugal, 4100-180
    • Not yet recruiting
    • Hospital CUF Porto S.A.
  • Porto, Portugal, 4050-342
    • Not yet recruiting
    • ULS De Santo António, E.P.E. - Hospital de Santo António
  • Vila Nova de Gaia, Portugal, 4434-502
    • Not yet recruiting
    • ULS De Gaia/Espinho E.P.E. - Hospital Eduardo Santos Silva
• Romania
  • Baia Mare, Romania, 430031
    • Not yet recruiting
    • Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
  • Bucharest, Romania, 010073
    • Not yet recruiting
    • Kilostop Junior SRL
  • Bucharest, Romania, 041451
    • Not yet recruiting
    • Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
  • Timișoara, Romania, 300226
    • Not yet recruiting
    • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
• Serbia
  • Belgrade, Serbia, 11000
    • Not yet recruiting
    • University Children's Hospital Tirsova
  • Belgrade, Serbia, 11070
    • Not yet recruiting
    • Institute for Mother and Child Health Care of Serbia
  • Novi Sad, Serbia, 21000
    • Not yet recruiting
    • Institute for Health Care of Children and Adolescents
• Slovakia
  • Bratislava, Slovakia, 833 40
    • Not yet recruiting
    • Narodny ustav detskych chorob
  • Košice, Slovakia, 040 01
    • Not yet recruiting
    • Detska fakultna nemocnica Kosice
  • Ľubochňa, Slovakia, 03491
    • Not yet recruiting
    • Narodny Endokrinologicky a diabetologicky ustav
• Spain
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Hospital Vall d'Hebrón_Endocrinología pediatríca
  • Esplugues de Llobregat, Spain, 08950
    • Not yet recruiting
    • Hospital Sant Joan de Déu
  • Seville, Spain, 41013
    • Not yet recruiting
    • Hospital Universitario Virgen del Rocio
• Sweden
  • Umeå, Sweden, 907 37
    • Not yet recruiting
    • Barn och ungdomscentrum Västerbotten - NU
  • Uppsala, Sweden, 75185
    • Not yet recruiting
    • Uppsala Universitetssjukhus
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Not yet recruiting
    • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Taichung, Taiwan, 402
    • Not yet recruiting
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 104
    • Not yet recruiting
    • Taipei Mackay Children's Hospital
  • Taoyuan District, Taiwan, 333
    • Not yet recruiting
    • Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
• Thailand
  • Bangkok, Thailand, 10300
    • Not yet recruiting
    • King Chulalongkorn Memorial Hospital_Ped-Nutrition
  • Pathum Thani, Thailand, 12120
    • Not yet recruiting
    • Thammasat Hospital_CRC
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Recruiting
    • Birmingham Children's Hospital
  • Liverpool, United Kingdom, L12 2AP
    • Recruiting
    • Alder Hey Children's Hospital
  • London, United Kingdom, NW1 1BU
    • Recruiting
    • University College Hospital - Paediatric Services
• United States
  • California
    • Escondido, California, United States, 92025
      • Not yet recruiting
      • Neighborhood Healthcare
  • Florida
    • Hollywood, Florida, United States, 33024
      • Recruiting
      • Encore Medical Research LLC
    • Jacksonville, Florida, United States, 32216
      • Not yet recruiting
      • Jacksonville Ctr For Clin Res
    • Weston, Florida, United States, 33331
      • Recruiting
      • Encore Medical Research of Weston
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Healthcare Atlanta
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • Columbus Research Foundation
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • Accel Research Sites-NeuroStudies
    • Snellville, Georgia, United States, 30078
      • Recruiting
      • Eastside Bariatric and Gen Surg
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Not yet recruiting
      • Solaris Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health - Riley Physicians Endo-Diab
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Not yet recruiting
      • Cotton O'Neil Clinical Research Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4124
      • Recruiting
      • Pennington Biomed Res Ctr
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Not yet recruiting
      • Barry J. Reiner, MD LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
    • Richfield, Minnesota, United States, 55423
      • Not yet recruiting
      • AES Minneapolis DRS
  • New York
    • Buffalo, New York, United States, 15203
      • Not yet recruiting
      • UBMD Physicians Group - Pediatrics - Conventus
    • Syracuse, New York, United States, 13210
      • Not yet recruiting
      • SUNY Upstate Medical Univ - Syracuse
    • The Bronx, New York, United States, 10467
      • Not yet recruiting
      • Advantage Clinical Trials
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Not yet recruiting
      • Valley Weight Loss Clinic
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Not yet recruiting
      • Centricity Research - Ohio
    • Dayton, Ohio, United States, 45429
      • Not yet recruiting
      • PriMED Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Not yet recruiting
      • Children's Physicians OU
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Not yet recruiting
      • UPMC Child Hosp-Pittsburgh
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Not yet recruiting
      • Prisma Health-Ped Endo
    • North Charleston, South Carolina, United States, 29405
      • Not yet recruiting
      • Coastal Carolina Research Ctr
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Not yet recruiting
      • Monument Health Clinical Rsrch
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • Not yet recruiting
      • LifeDoc Health
  • Texas
    • Houston, Texas, United States, 77065
      • Recruiting
      • DM Clinical
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • Pinnacle Clinical Research
    • San Antonio, Texas, United States, 78207
      • Not yet recruiting
      • DM Clinical
    • San Antonio, Texas, United States, 78215
      • Not yet recruiting
      • The Texas Liver Institute
    • Shavano Park, Texas, United States, 78231
      • Not yet recruiting
      • Consano Clin Res-Shavano Park
    • Weslaco, Texas, United States, 78596
      • Not yet recruiting
      • Texas Valley Clinical Research
  • Utah
    • Syracuse, Utah, United States, 84075
      • Not yet recruiting
      • Wee Care Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Placebo cagrilintide; Participants will receive placebo matched to cagrilintide subcutaneously.; Drug: Placebo semaglutide; Participants will receive placebo matched to semaglutide subcutaneously.; Drug: Semaglutide; Participants will receive semaglutide subcutaneously.; Drug: Cagrilintide; Participants will receive cagrilintide subcutaneously.
Experimental: 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.	Drug: Placebo semaglutide; Participants will receive placebo matched to semaglutide subcutaneously.; Drug: Semaglutide; Participants will receive semaglutide subcutaneously.
Experimental: 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.	Drug: Placebo cagrilintide; Participants will receive placebo matched to cagrilintide subcutaneously.; Drug: Cagrilintide; Participants will receive 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.	Drug: Placebo cagrilintide; Participants will receive placebo matched to cagrilintide subcutaneously.; Drug: Placebo semaglutide; Participants will receive placebo matched to semaglutide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body mass index (BMI)	Measured in percentage (%).	Baseline (week 0), week 68

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in %.	Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)	Measured as SDS score.	Baseline (week 0), week 68
Relative change in BMI	Measured in %.	Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction	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)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of body weight (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of body weight (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of body weight (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of body weight (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=5% reduction of BMI (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of BMI (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of BMI (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of BMI (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of BMI (yes/no)	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who achieved normal BMI	Measured as count of participants.	Baseline (week 0), week 68
Number of participants who shifted from obese to non-obese BMI class	Measured as count of participants.	Baseline (week 0), week 68
Change in waist circumference	Measured in centimeter (cm).	Baseline (week 0), week 68 and week 224
Change in waist-to-height ratio	Measured as ratio.	Baseline (week 0), week 68
Absolute change in total fat mass by dual energy X-ray absorption (DXA)	Measured in kilograms (kg).	Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA	Measured in % points.	Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA	Measured in kg.	Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA	Measured in %.	Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA	Measured in % points.	Baseline (week 0), week 68
Absolute change in lean body mass by DXA	Measured in kg.	Baseline (week 0), week 68
Relative to total body mass change in lean body mass by DXA	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	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	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	Measured in % points.	Baseline (week 0), week 68 and week 224
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat	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	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	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	Measured in %.	Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in BMI percentage of the 95th percentile	Measured in % points.	Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)	Measured as ratio.	Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Triglycerides	Measured as ratio.	Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Non-HDL cholesterol	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT)	Measured in Units per Liter (U/L).	Baseline (week 0), week 68 and week 224
Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	Baseline (week 0), week 68 and week 224
Change in diastolic blood pressure	Measured in mmHg.	Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by ultrasonographic methods	Measured as ratio.	Baseline (week 0), week 68 and week 224
Change in glycated haemoglobin (HbA1c) (% points)	Measured in % points.	Baseline (week 0), week 68 and week 224
Change in HbA1c (millimoles per mole [mmol/mol])	Measured in mmol/mol.	Baseline (week 0), week 68 and week 224
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])	Measured in mmol/L.	Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL])	Measured in mg/dL.	Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin	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	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 %	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%	Measured as count of participants.	At week 68
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%	Measured as count of participants.	At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease	Measured as count of participants.	Baseline (week 0), week 68
Number of participants taking antihypertensive medication at baseline, stop or decrease	Measured as count of participants.	Baseline (week 0), week 68
Number of participants taking lipid lowering medication at baseline, stop or decrease	Measured as count of participants.	Baseline (week 0), week 68
Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score	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	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	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	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	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)	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)	Measured as counts.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent adverse events (TEAEs)	Measured as count of events.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent serious adverse events (TESAEs)	Measured as count of events.	Baseline (week 0), week 68 and week 224
Number of treatment-emergent hypoglycaemic episodes	Measured as count of events.	Baseline (week 0), week 68 and week 224
Change in pulse rate	Measured in beats per minute (beats/min).	Baseline (week 0), week 68
Change in calcitonin	Measured in nanograms per liter (ng/L).	Baseline (week 0), week 68
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state	Measured in liters per hour (L/h).	Baseline (week 0), week 68
Average concentration (Cavg) of semaglutide and cagrilintide at steady state	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	Measured in hours nanomoles per liter (h·nmol/L).	Baseline (week 0), week 68

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): March 20, 2030
• Study Completion (Estimated): September 20, 2033

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; semaglutide; cagrilintide
• Other Study ID Numbers: NN9838-4968; U1111-1299-4751 (Other Identifier: World Health Organization (WHO)); 2023-509176-42 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No