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NCT07282613PHASE3Recruiting

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes

Novo Nordisk A/S

Start Date

8/4/2026

Completion Date

3/30/2030

Summary

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Eligibility Criteria

Age Range: 10 years to 18 years

Key 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. * Age 10 to \< 18 years at the time of signing the informed consent. * Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening. * Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens: * Insulin (any regimen) * Metformin * SGLT2i * HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening. * Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening. * (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening. * (b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used. Key Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. * Known or previous diagnosis of hypoparathyroidism. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening. * Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment 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.

Interventions

DRUG

CagriSema (Cagrilintide B and Semaglutide I)

DRUG

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

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Conditions

Diabetes Mellitus, Type 2

Locations

Yale School of Medicine

New Haven, Connecticut 06511

United States

Encore Medical Research Boynton Beach

Boynton Beach, Florida 33436

United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida 32207

United States

Innovus Clinical

Kissimmee, Florida 34741

United States

D&H National Research Centers

Tamarac, Florida 33321

United States

Clinical Research Trials of Florida

Tampa, Florida 33607

United States

Columbus Research Foundation

Columbus, Georgia 31904

United States

Eastside Bariatric and Gen Surg

Snellville, Georgia 30078

United States

SIU Medicine

Springfield, Illinois 62702

United States

Riley Hospital For Children

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52242

United States

Great Lakes Research Inst.

Southfield, Michigan 48075

United States

UBMD Pediatrics

Buffalo, New York 14203

United States

NYU Langone Orthopedic Center

New York, New York 10016

United States

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania 19104

United States

Monument Health Clinical Rsrch

Rapid City, South Dakota 57701

United States

LifeDoc Health

Memphis, Tennessee 38115

United States

Amir Ali Hassan, MD, PA

Houston, Texas 77089

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

UVA Health Systems

Charlottesville, Virginia 22903

United States

Seattle Children's Research Institute

Seattle, Washington 98105

United States

Centro de Investigaciones Metabólicas

Capital Federal, Buenos Aires C1056ABI

Argentina

Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio

San Miguel de Tucumán, Tucumán Province T4000DPX

Argentina

IMOBA

City of Buenos Aires, C1056ABH

Argentina

CIPADI

Godoy Cruz, M5501ARP

Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca

San Miguel de Tucumán, T4000IHE

Argentina

Hospital Universitário Walter Cantídio

Bairro Rodolfo Teófilo, Fortaleza, Ceará 60416-000

Brazil

Centro de Diabetes Curitiba

Curitiba, Paraná 80810-040

Brazil

Instituto da Criança com Diabetes - ICD

Porto Alegre, Rio Grande do Sul 91350-250

Brazil

Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo 14051-140

Brazil

IBTED Tecnologia e Educação em Diabetes - EPP

São Paulo, São Paulo 04038-032

Brazil

Instituto da Criança e do Adolescente do HCFMUSP

São Paulo, São Paulo 05403-000

Brazil

Salud SURA Industriales

Bogotá, Antioquia 50017

Colombia

Fundacion Valle del Lili

Cali, Valle del Cauca Department 760032

Colombia

Endolife Specialty Hospitals

Guntur, Andhra Pradesh 522001

India

BAPS Pramukh Swami Hospital

Surat, Gujarat 395009

India

Indira Gandhi Institute of child health

Bangalore, Karnataka 560011

India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi 110060

India

Maulana Azad Medical College

Delhi, New Delhi 110002

India

Regency Hospital

Kanpur, Uttar Pradesh 208006

India

Institute of Child Health

Kolkata, West Bengal 700017

India

Excel Endocrine Centre

Kolhāpur, 416008

India

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029

India

HaEmek MC - Pediatric Endocrinology department

Afula, 1834111

Israel

Soroka MC - Pediatric Endocrinology

Beersheba, 84101

Israel

Rambam MC - Department of Pediatrics A

Haifa, 31096

Israel

Carmel MC - Pediatric Endocrinology Unit

Haifa, 3436212

Israel

Shaare Zedek MC - Pediatric Endocrinology

Jerusalem, 9103102

Israel

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur 59100

Malaysia

Hospital Putrajaya

Putrajaya, 62250

Malaysia

Instituto Nacional de Pediatría

Coyoacán, Mexico City 04530

Mexico

IECSI Centro de Investigación Clínica

Monterrey, Nuevo León 64310

Mexico

Centro de Investigación y Control Metabólico S. C.

San Nicolás de los Garza, Nuevo León 66465

Mexico

UMAE CMN Siglo XXI Dept Endocrinología Pediátrica

Cuauhtémoc, 06720

Mexico

Consultorio de Endocrinología y Pediatría

Puebla City, 72190

Mexico

Taipei Mackay Children's Hospital

Taipei, 104

Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, 10330

Thailand

Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

Chiang Mai, 50200

Thailand