OverweightPhase 3NCT07253285
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
A Phase 3 study testing Cagrilintide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 121 sites in 26 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Cagrilintide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 121 sitesin 26 countries
- Study dates
- 8 Jan 2026to 20 Sep 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
121 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
121 sites in 26 countries
United States34 sites, 34 recruiting
- Recruiting
Children's Healthcare Atlanta
Atlanta, Georgia, 30329
- Recruiting
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229
- Recruiting
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, 70808-4124
- Not yet recruiting
UBMD Physicians Group - Pediatrics - Conventus
Buffalo, New York, 14203
- Recruiting
Columbus Research Foundation
Columbus, Georgia, 31904
- Recruiting
Centricity Research - Ohio
Columbus, Ohio, 43213
- Recruiting
PriMed Clinical Research
Dayton, Ohio, 45429
- Recruiting
Accel Research Sites-NeuroStudies
Decatur, Georgia, 30030
- Recruiting
Neighborhood Healthcare
Escondido, California, 92025
- Recruiting
Valley Weight Loss Clinic
Fargo, North Dakota, 58104
- Not yet recruiting
Prisma Health-Ped Endo
Greenville, South Carolina, 29615
- Recruiting
Encore Medical Research LLC
Hollywood, Florida, 33024
- Recruiting
DM Clinical
Houston, Texas, 77065
- Recruiting
IU Health - Riley Physicians Endo-Diab
Indianapolis, Indiana, 46202
- Recruiting
Jacksonville Ctr for Clin Res
Jacksonville, Florida, 32216
- Recruiting
AMR Clinical
Layton, Utah, 84041
- Recruiting
LifeDoc Health
Memphis, Tennessee, 38115
- Recruiting
Solaris Clinical Research
Meridian, Idaho, 83646
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405
- Not yet recruiting
Children's Physicians OU
Oklahoma City, Oklahoma, 73104
- Not yet recruiting
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224
- Not yet recruiting
Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701
- Recruiting
Synexus Clinical Research US-MN
Richfield, Minnesota, 55423
- Not yet recruiting
DM Clinical
San Antonio, Texas, 78207
- Recruiting
The Texas Liver Institute
San Antonio, Texas, 78215
- Recruiting
Pinnacle Clinical Research
San Antonio, Texas, 78222
- Recruiting
Consano Clin Res-Shavano Park
Shavano Park, Texas, 78231
- Recruiting
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078
- Recruiting
SUNY Upstate Medical Univ - Syracuse
Syracuse, New York, 13210
- Not yet recruiting
Advantage Clinical Trials
The Bronx, New York, 10467
- Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
- Recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
- Recruiting
Encore Medical Research of Weston
Weston, Florida, 33331
China9 sites, 9 recruiting
- Recruiting
Capital Center for Children's Health, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, 100020
- Not yet recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
- Not yet recruiting
The First Bethune Hospital of Jilin University-Pediatric
Changchun, Jilin, 130021
- Recruiting
Chengdu Women's and Children's Central Hospital- Pediatric Endocrinology, Genetics and Metabolism
Chengdu, Sichuan, 610031
- Recruiting
Shandong Provincial Hospital-Pediatric
Jinan, Shandong, 250098
- Recruiting
Children's Hospital of Fudan University-Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 201102
- Recruiting
Wuhan Children Hospital-Endocrine Genetics and Metabolism
Wuhan, Hubei, 430019
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology-Pediatric
Wuhan, Hubei, 430030
- Recruiting
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou, Henan, 450018
India9 sites, 9 recruiting
- Not yet recruiting
Indira Gandhi Institute of child health
Bangalore, Karnataka, 560011
- Not yet recruiting
Maulana Azad Medical College
Delhi, New Delhi, 110002
- Not yet recruiting
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
- Not yet recruiting
Regency Hospital
Kanpur, Uttar Pradesh, 208006
- Not yet recruiting
Excel Endocrine Centre
Kolhāpur, 416008
- Not yet recruiting
Institute of Child Health
Kolkata, West Bengal, 700017
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Not yet recruiting
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029
- Not yet recruiting
BAPS Pramukh Swami Hospital
Surat, Gujarat, 395009
Bulgaria4 sites, 4 recruiting
- Recruiting
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, 4001
- Recruiting
SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
Sofia, 1606
- Not yet recruiting
Medical center Children's Health EOOD
Sofia, 1618
- Recruiting
UMHAT Sveta Marina EAD, First Pediatric Clinic
Varna, 9010
Israel4 sites, 4 recruiting
- Not yet recruiting
Rambam MC - Department of Pediatrics A
Haifa, 31096
- Not yet recruiting
Shaare Zedek MC - Endocrinology Department
Jerusalem, 9103102
- Not yet recruiting
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, 49202
- Not yet recruiting
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin, 7033001
Italy4 sites, 4 recruiting
- Not yet recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
Milan, Lombardy, 20122
- Not yet recruiting
AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
Novara, Piedmont, 28100
- Not yet recruiting
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
Trieste, 34137
- Not yet recruiting
A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
Verona, Veneto, 37126
Poland4 sites, 4 recruiting
- Not yet recruiting
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
Dziekanów Leśny, 05-092
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
- Not yet recruiting
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, 35-301
- Not yet recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800
Romania4 sites, 4 recruiting
- Not yet recruiting
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, 430031
- Recruiting
Kilostop Junior SRL
Bucharest, 010073
- Recruiting
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, 041451
- Recruiting
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300226
Slovakia4 sites, 4 recruiting
- Not yet recruiting
Narodny Ustav Detskych Chorob
Bratislava, 833 40
- Recruiting
Detska Fakultna nemocnica Kosice
Košice, 040 01
- Recruiting
Narodny Endokrinologicky a diabetologicky ustav
Ľubochňa, 03491
- Not yet recruiting
Nemocnica Poprad, a.s.
Poprad, 058 45
Taiwan4 sites, 4 recruiting
- Recruiting
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 833
- Recruiting
Chung Shan Medical University Hospital
Taichung, 402
- Recruiting
Taipei Mackay Children's Hospital
Taipei, 104
- Recruiting
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
Taoyuan, 333
Australia3 sites, 3 recruiting
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6009
- Recruiting
Queensland Children's Hospital
South Brisbane, Queensland, 4101
- Recruiting
The Children's Hospital at Westmead - Clinical Research Centre
Westmead, New South Wales, 2145
Croatia3 sites, 3 recruiting
- Not yet recruiting
Clinical Hospital Centre Rijeka_Pediatric
Rijeka, 51 000
- Not yet recruiting
KBC "Sestre Milosrdnice"
Zagreb, 10 000
- Not yet recruiting
Klinika Za Djecje Bolesti Zagreb_Endocrinology
Zagreb, 10000
Hungary3 sites, 3 recruiting
- Recruiting
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
Budapest, 1023
- Not yet recruiting
Semmelweis Egyetem ÁOK
Budapest, 1083
- Not yet recruiting
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
Szeged, 6720
Malaysia3 sites, 3 recruiting
- Not yet recruiting
Hospital Tunku Azizah
Kampung Baru, Kuala Lumpur, 50300
- Recruiting
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
- Recruiting
Hospital Sibu
Sibu, Sarawak, 96000
Mexico3 sites, 3 recruiting
- Not yet recruiting
CHRISTUS - Latam Hub Excellence and Innovation Center
Monterrey, Nuevo León, 64060
- Not yet recruiting
IECSI Centro de Investigación Clínica
Monterrey, Nuevo León, 64310
- Not yet recruiting
Consultorio de Endocrinología y Pediatría
Puebla City, 72190
Portugal3 sites, 3 recruiting
- Not yet recruiting
ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
Porto, 4050-651
- Not yet recruiting
CUF Porto_Serviço de Pediatria
Porto, 4100-180
- Not yet recruiting
ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
Vila Nova de Gaia, 4434-502
Serbia3 sites, 3 recruiting
- Recruiting
University Children's Hospital Tirsova
Belgrade, 11000
- Recruiting
Institute for Mother and Child Health Care of Serbia
Belgrade, 11070
- Recruiting
Institute for Health Care of Children and Adolescents
Novi Sad, 21000
Spain3 sites, 3 recruiting
- Not yet recruiting
Hosp. Vall d'Hebrón_Endocrinología pediatríca
Barcelona, 08035
- Not yet recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
- Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
- Recruiting
Alder Hey Children's Hospital
Liverpool, L12 2AP
- Recruiting
University College Hospital - Paediatric Services
London, NW1 1BU
Austria2 sites, 2 recruiting
- Recruiting
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, 6020
- Recruiting
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020
Belgium2 sites, 2 recruiting
- Recruiting
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, 1090
- Recruiting
UZA - Universitair Ziekenhuis Antwerpen
Edegem, 2650
Colombia2 sites, 2 recruiting
- Not yet recruiting
Fundación Santa Fe de Bogotá
Bogotá, 110111
- Not yet recruiting
Servicios de Salud Ips Suramericana S.A.S.
Medellín, Antioquia, 05001
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aalborg Universitetshospital - Børne og Ungeafdelingen
Aalborg, 9000
- Recruiting
Holbæk Sygehus - Børne- og Ungeafdelingen
Holbæk, 4300
Netherlands2 sites, 1 recruiting
- Not yet recruiting
Jeroen Bosch Zkh
's-Hertogenbosch, 5223 GZ
- Completed
Meander MC
Amersfoort, 3813 TZ
Sweden2 sites, 2 recruiting
- Not yet recruiting
Barn och ungdomscentrum Västerbotten - NU
Umeå, 907 37
- Not yet recruiting
Akademiska barnsjukhuset - klinisk forskningsmottagning
Uppsala, 75185
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital_Ped-Nutrition
Bangkok, 10300
- Recruiting
Thammasat Hospital_CRC
Pathum Thani, 12120
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Participants will receive cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive semaglutide subcutaneously.
Placebo cagrilintideDrug
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutideDrug
Participants will receive placebo matched to semaglutide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | 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. Receives: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
| Semaglutide | Experimental | 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. Receives: Drug: Semaglutide; Drug: Placebo semaglutide |
| Cagrilintide | Experimental | 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. Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body mass index (BMI)
Measured in percentage (%).
Measured: Baseline (week 0), week 68
Secondary outcomes (73)
Relative change in body weight
Measured in %.
Measured: Baseline (week 0), week 68
Change in BMI Standard Deviation Score (SDS)
Measured as SDS score.
Measured: Baseline (week 0), week 68
Relative change in BMI
Measured in %.
Measured: Baseline (week 0), week 68 and week 224
Number of participants in weight category reduction
Measured as count of participants.
Measured: 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.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of body weight (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of body weight (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of body weight (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of body weight (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=5% reduction of BMI (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=10% reduction of BMI (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=15% reduction of BMI (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=20% reduction of BMI (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved >=25% reduction of BMI (yes/no)
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who achieved normal BMI
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants who shifted from obese to non-obese BMI class
Measured as count of participants.
Measured: Baseline (week 0), week 68
Change in waist circumference
Measured in centimeter (cm).
Measured: Baseline (week 0), week 68 and week 224
Change in waist-to-height ratio
Measured as ratio.
Measured: Baseline (week 0), week 68
Absolute change in total fat mass by dual energy X-ray absorption (DXA)
Measured in kilograms (kg).
Measured: Baseline (week 0), week 68
Relative to baseline change in total fat mass by DXA
Measured in %.
Measured: Baseline (week 0), week 68
Relative to total body mass change in total fat mass by DXA
Measured in % points.
Measured: Baseline (week 0), week 68
Absolute change in visceral fat mass by DXA
Measured in kg.
Measured: Baseline (week 0), week 68
Relative to baseline change in visceral fat mass by DXA
Measured in %.
Measured: Baseline (week 0), week 68
Relative to total body mass change in visceral fat mass by DXA
Measured in % points.
Measured: Baseline (week 0), week 68
Absolute change in lean body mass by DXA
Measured in kg.
Measured: Baseline (week 0), week 68
Relative to total body mass change in lean body mass by DXA
Measured in % points.
Measured: 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).
Measured: 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 %.
Measured: 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.
Measured: Baseline (week 0), week 68 and week 224
Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat
Measured in liters.
Measured: 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 %.
Measured: 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.
Measured: 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 %.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Change in BMI percentage of the 95th percentile
Measured in % points.
Measured: Baseline (week 0), week 68
Ratio to baseline highly sensitive C-reactive protein (hs-CRP)
Measured as ratio.
Measured: Baseline (week 0), week 68
Ratio to baseline in lipids: Total cholesterol
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Triglycerides
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in lipids: Non-HDL cholesterol
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Change in Alanine Transaminase (ALT)
Measured in Units per Liter (U/L).
Measured: Baseline (week 0), week 68 and week 224
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Measured: Baseline (week 0), week 68 and week 224
Change in diastolic blood pressure
Measured in mmHg.
Measured: Baseline (week 0), week 68 and week 224
Ratio to baseline in liver stiffness measured by ultrasonographic methods
Measured as ratio.
Measured: Baseline (week 0), week 68 and week 224
Change in glycated haemoglobin (HbA1c) (% points)
Measured in % points.
Measured: Baseline (week 0), week 68 and week 224
Change in HbA1c (millimoles per mole [mmol/mol])
Measured in mmol/mol.
Measured: Baseline (week 0), week 68 and week 224
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Measured in mmol/L.
Measured: Baseline (week 0), week 68
Change in FPG (milligrams per deciliter [mg/dL])
Measured in mg/dL.
Measured: Baseline (week 0), week 68
Ratio to baseline in fasting serum insulin
Measured as ratio.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 68
Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%
Measured as count of participants.
Measured: At week 68
Number of participants taking glucose lowering medication at baseline, stop or decrease
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants taking antihypertensive medication at baseline, stop or decrease
Measured as count of participants.
Measured: Baseline (week 0), week 68
Number of participants taking lipid lowering medication at baseline, stop or decrease
Measured as count of participants.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (week 0), week 68 and week 224
Number of treatment-emergent adverse events (TEAEs)
Measured as count of events.
Measured: Baseline (week 0), week 68 and week 224
Number of treatment-emergent serious adverse events (TESAEs)
Measured as count of events.
Measured: Baseline (week 0), week 68 and week 224
Number of treatment-emergent hypoglycaemic episodes
Measured as count of events.
Measured: Baseline (week 0), week 68 and week 224
Change in pulse rate
Measured in beats per minute (beats/min).
Measured: Baseline (week 0), week 68
Change in calcitonin
Measured in nanograms per liter (ng/L).
Measured: Baseline (week 0), week 68
Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state
Measured in liters per hour (L/h).
Measured: Baseline (week 0), week 68
Average concentration (Cavg) of semaglutide and cagrilintide at steady state
Measured in nanomoles per liter (nmol/L).
Measured: 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).
Measured: Baseline (week 0), week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start8 Jan 2026
- Primary completion20 Mar 2030 (estimated)
- Study completion20 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253285
- Sponsor's protocol ID
- NN9838-4968
- Other IDs
- U1111-1299-4751, 2023-509176-42, 2023
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on NovoNordisk trials.com.