New combo drug aims to help teens shed excess weight

NCT ID NCT07253285

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests two drugs, cagrilintide and semaglutide (alone or together as CagriSema), to help children and adolescents with overweight or obesity lose weight. About 460 participants will receive either the drugs or a placebo for up to 5 years. The main goal is to see how much their body mass index (BMI) changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Cagrilintide and semaglutide (CagriSema)
What this could lead to: If successful, this could provide a new, effective weight-loss option for young people with obesity, helping reduce health risks.
What could go wrong: This is an early Phase 3 trial, so results are not guaranteed. Side effects are possible, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 460 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

120 sites in 26 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B
NOT_YET_RECRUITING

Verona, Veneto, 37126, Italy
AMR Clinical
RECRUITING

Layton, Utah, 84041, United States
AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infantile - SCDU Pediatria
NOT_YET_RECRUITING

Novara, Piedmont, 28100, Italy
Aalborg Universitetshospital - Børne og Ungeafdelingen
NOT_YET_RECRUITING

Aalborg, 9000, Denmark
Accel Research Sites-NeuroStudies
RECRUITING

Decatur, Georgia, 30030, United States
Advantage Clinical Trials
NOT_YET_RECRUITING

The Bronx, New York, 10467, United States
Akademiska barnsjukhuset - klinisk forskningsmottagning
NOT_YET_RECRUITING

Uppsala, 75185, Sweden
Alder Hey Children's Hospital
RECRUITING

Liverpool, L12 2AP, United Kingdom
All India Institute of Medical Sciences (AIIMS)
NOT_YET_RECRUITING

New Delhi, 110029, India
BAPS Pramukh Swami Hospital
NOT_YET_RECRUITING

Surat, Gujarat, 395009, India
Barn och ungdomscentrum Västerbotten - NU
NOT_YET_RECRUITING

Umeå, 907 37, Sweden
Barry J. Reiner, MD LLC
RECRUITING

Baltimore, Maryland, 21229, United States
Beijing Children's Hospital, Capital Medical University
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100045, China
Birmingham Children's Hospital
RECRUITING

Birmingham, B4 6NH, United Kingdom
CHRISTUS - Latam Hub Excellence and Innovation Center
NOT_YET_RECRUITING

Monterrey, Nuevo León, 64060, Mexico
CUF Porto_Serviço de Pediatria
NOT_YET_RECRUITING

Porto, 4100-180, Portugal
Capital Center for Children's Health, Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100020, China
Centricity Research - Ohio
RECRUITING

Columbus, Ohio, 43213, United States
Chang Gung Memorial Hospital - Kaohsiung Branch
NOT_YET_RECRUITING

Kaohsiung City, 833, Taiwan
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
NOT_YET_RECRUITING

Taoyuan, 333, Taiwan
Chengdu Women's and Children's Central Hospital
RECRUITING

Chengdu, Sichuan, 610031, China
Children's Healthcare Atlanta
RECRUITING

Atlanta, Georgia, 30329, United States
Children's Hospital of Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 201102, China
Children's Physicians OU
NOT_YET_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Chung Shan Medical University Hospital
NOT_YET_RECRUITING

Taichung, 402, Taiwan
Clinical Hospital Centre Rijeka_Pediatric
NOT_YET_RECRUITING

Rijeka, 51 000, Croatia
Coastal Carolina Research Ctr
RECRUITING

North Charleston, South Carolina, 29405, United States
Columbus Research Foundation
RECRUITING

Columbus, Georgia, 31904, United States
Consano Clin Res-Shavano Park
RECRUITING

Shavano Park, Texas, 78231, United States
Consultorio de Endocrinología y Pediatría
NOT_YET_RECRUITING

Puebla City, 72190, Mexico
Cotton O'Neil Clinical Research Center
RECRUITING

Topeka, Kansas, 66606, United States
DM Clinical
RECRUITING

Houston, Texas, 77065, United States
DM Clinical
NOT_YET_RECRUITING

San Antonio, Texas, 78207, United States
Detska Fakultna nemocnica Kosice
NOT_YET_RECRUITING

Košice, 040 01, Slovakia
Eastside Bariatric and Gen Surg
RECRUITING

Snellville, Georgia, 30078, United States
Encore Medical Research LLC
RECRUITING

Hollywood, Florida, 33024, United States
Encore Medical Research of Weston
RECRUITING

Weston, Florida, 33331, United States
Endolife Specialty Hospitals
NOT_YET_RECRUITING

Guntur, Andhra Pradesh, 522001, India
Excel Endocrine Centre
NOT_YET_RECRUITING

Kolhāpur, 416008, India
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia
NOT_YET_RECRUITING

Milan, Lombardy, 20122, Italy
Fundación Santa Fe de Bogotá
NOT_YET_RECRUITING

Bogotá, 110111, Colombia
Henan Children's Hospital Zhengzhou Children's Hospital
RECRUITING

Zhengzhou, Henan, 450018, China
Holbæk Sygehus - Børne- og Ungeafdelingen
RECRUITING

Holbæk, 4300, Denmark
Hosp. Vall d'Hebrón_Endocrinología pediatríca
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Hospital Sant Joan de Déu
NOT_YET_RECRUITING

Esplugues de Llobregat, 08950, Spain
Hospital Sibu
RECRUITING

Sibu, Sarawak, 96000, Malaysia
Hospital Tunku Azizah
NOT_YET_RECRUITING

Kampung Baru, Kuala Lumpur, 50300, Malaysia
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING

Seville, 41013, Spain
IECSI Centro de Investigación Clínica
NOT_YET_RECRUITING

Monterrey, Nuevo León, 64310, Mexico
IRCCS materno infantile Burlo Garofolo - Clinica Pediatrica
NOT_YET_RECRUITING

Trieste, 34137, Italy
IU Health - Riley Physicians Endo-Diab
RECRUITING

Indianapolis, Indiana, 46202, United States
Indira Gandhi Institute of child health
NOT_YET_RECRUITING

Bangalore, Karnataka, 560011, India
Institute for Health Care of Children and Adolescents
RECRUITING

Novi Sad, 21000, Serbia
Institute for Mother and Child Health Care of Serbia
RECRUITING

Belgrade, 11070, Serbia
Institute of Child Health
NOT_YET_RECRUITING

Kolkata, West Bengal, 700017, India
Jacksonville Ctr for Clin Res
RECRUITING

Jacksonville, Florida, 32216, United States
Jeroen Bosch Zkh
NOT_YET_RECRUITING

's-Hertogenbosch, 5223 GZ, Netherlands
KBC "Sestre Milosrdnice"
NOT_YET_RECRUITING

Zagreb, 10 000, Croatia
Kilostop Junior SRL
RECRUITING

Bucharest, 010073, Romania
King Chulalongkorn Memorial Hospital_Ped-Nutrition
RECRUITING

Bangkok, 10300, Thailand
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
NOT_YET_RECRUITING

Rzeszów, 35-301, Poland
Klinika Za Djecje Bolesti Zagreb_Endocrinology
NOT_YET_RECRUITING

Zagreb, 10000, Croatia
LifeDoc Health
RECRUITING

Memphis, Tennessee, 38115, United States
Maulana Azad Medical College
NOT_YET_RECRUITING

Delhi, New Delhi, 110002, India
Meander MC
COMPLETED

Amersfoort, 3813 TZ, Netherlands
Medical center Children's Health EOOD
NOT_YET_RECRUITING

Sofia, 1618, Bulgaria
Monument Health Clinical Rsrch
NOT_YET_RECRUITING

Rapid City, South Dakota, 57701, United States
Narodny Endokrinologicky a diabetologicky ustav
RECRUITING

Ľubochňa, 03491, Slovakia
Narodny Ustav Detskych Chorob
NOT_YET_RECRUITING

Bratislava, 833 40, Slovakia
Neighborhood Healthcare
RECRUITING

Escondido, California, 92025, United States
Nemocnica Poprad, a.s.
NOT_YET_RECRUITING

Poprad, 058 45, Slovakia
Pennington Biomed Res Ctr
RECRUITING

Baton Rouge, Louisiana, 70808-4124, United States
Perth Children's Hospital
RECRUITING

Nedlands, Western Australia, 6009, Australia
Pinnacle Clinical Research
RECRUITING

San Antonio, Texas, 78222, United States
PriMed Clinical Research
RECRUITING

Dayton, Ohio, 45429, United States
Prisma Health-Ped Endo
NOT_YET_RECRUITING

Greenville, South Carolina, 29615, United States
Queensland Children's Hospital
RECRUITING

South Brisbane, Queensland, 4101, Australia
Rambam MC - Department of Pediatrics A
NOT_YET_RECRUITING

Haifa, 31096, Israel
Regency Hospital
NOT_YET_RECRUITING

Kanpur, Uttar Pradesh, 208006, India
SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases
NOT_YET_RECRUITING

Sofia, 1606, Bulgaria
SUNY Upstate Medical Univ - Syracuse
NOT_YET_RECRUITING

Syracuse, New York, 13210, United States
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
NOT_YET_RECRUITING

Zabrze, 41-800, Poland
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym
NOT_YET_RECRUITING

Dziekanów Leśny, 05-092, Poland
Schneider MC - Endrocrinology and Diabetes
NOT_YET_RECRUITING

Petah Tikva, 49202, Israel
Semmelweis Egyetem ÁOK
NOT_YET_RECRUITING

Budapest, 1083, Hungary
Servicios de Salud Ips Suramericana S.A.S.
NOT_YET_RECRUITING

Medellín, Antioquia, 05001, Colombia
Shaare Zedek MC - Endocrinology Department
NOT_YET_RECRUITING

Jerusalem, 9103102, Israel
Shamir MC - Pediatric and Adolescents Endocrinology unit
NOT_YET_RECRUITING

Ẕerifin, 7033001, Israel
Shandong Provincial Hospital-Pediatric
RECRUITING

Jinan, Shandong, 250098, China
Sir Ganga Ram Hospital
NOT_YET_RECRUITING

New Delhi, National Capital Territory of Delhi, 110060, India
Solaris Clinical Research
RECRUITING

Meridian, Idaho, 83646, United States
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
RECRUITING

Timișoara, 300226, Romania
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
RECRUITING

Bucharest, 041451, Romania
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
NOT_YET_RECRUITING

Baia Mare, 430031, Romania
Synexus Clinical Research US-MN
RECRUITING

Richfield, Minnesota, 55423, United States
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
NOT_YET_RECRUITING

Szeged, 6720, Hungary
Taipei Mackay Children's Hospital
NOT_YET_RECRUITING

Taipei, 104, Taiwan
Texas Valley Clinical Research
RECRUITING

Weslaco, Texas, 78596, United States
Thammasat Hospital_CRC
RECRUITING

Pathum Thani, 12120, Thailand
The Children's Hospital at Westmead - Clinical Research Centre
RECRUITING

Westmead, New South Wales, 2145, Australia
The First Bethune Hospital of Jilin University-Pediatric
NOT_YET_RECRUITING

Changchun, Jilin, 130021, China
The Texas Liver Institute
RECRUITING

San Antonio, Texas, 78215, United States
UBMD Physicians Group - Pediatrics - Conventus
NOT_YET_RECRUITING

Buffalo, New York, 14203, United States
ULS De Gaia/Espinho_H.Santos Silva_Unidade Ensaios Clínicos
NOT_YET_RECRUITING

Vila Nova de Gaia, 4434-502, Portugal
ULS De Santo António, E.P.E. _CMIN_Serviço de Pediatria
NOT_YET_RECRUITING

Porto, 4050-651, Portugal
UMHAT Sveta Marina EAD, First Pediatric Clinic
NOT_YET_RECRUITING

Varna, 9010, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
NOT_YET_RECRUITING

Plovdiv, 4001, Bulgaria
UPMC Child Hosp-Pittsburgh
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
UZ Brussel - Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING

Brussels, 1090, Belgium
UZA - Universitair Ziekenhuis Antwerpen
NOT_YET_RECRUITING

Edegem, 2650, Belgium
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, 430022, China
University Children's Hospital Tirsova
RECRUITING

Belgrade, 11000, Serbia
University College Hospital - Paediatric Services
RECRUITING

London, NW1 1BU, United Kingdom
University Malaya Medical Centre
RECRUITING

Lembah Pantai, Kuala Lumpur, 59100, Malaysia
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55455, United States
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
NOT_YET_RECRUITING

Innsbruck, 6020, Austria
Universitätsklinik für Kinder und Jugendheilkunde Haus E
NOT_YET_RECRUITING

Salzburg, 5020, Austria
Uniwersytecki Szpital Kliniczny w Opolu
NOT_YET_RECRUITING

Opole, 45-401, Poland
Valley Weight Loss Clinic
RECRUITING

Fargo, North Dakota, 58104, United States
Wuhan Children Hospital
RECRUITING

Wuhan, Hubei, 430019, China
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
NOT_YET_RECRUITING

Budapest, 1023, Hungary

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