RecruitingPhase 3NCT07282613

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

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

Sponsor

Novo Nordisk A/S

Enrollment

80 participants

Start Date

Aug 4, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CagriSema (Cagrilintide B and Semaglutide I) and a drug called Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) for people with diabetes mellitus, type 2. The study is currently recruiting participants at 58 locations. People eligible for this study include aged 10 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCagriSema (Cagrilintide B and Semaglutide I)

Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

DRUGPlacebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Locations(58)

Yale School of Medicine

New Haven, Connecticut, United States

Encore Medical Research Boynton Beach

Boynton Beach, Florida, United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Innovus Clinical

Kissimmee, Florida, United States

D&H National Research Centers

Tamarac, Florida, United States

Clinical Research Trials of Florida

Tampa, Florida, United States

Columbus Research Foundation

Columbus, Georgia, United States

Eastside Bariatric and Gen Surg

Snellville, Georgia, United States

SIU Medicine

Springfield, Illinois, United States

Riley Hospital For Children

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Great Lakes Research Inst.

Southfield, Michigan, United States

UBMD Pediatrics

Buffalo, New York, United States

NYU Langone Orthopedic Center

New York, New York, United States

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, United States

Monument Health Clinical Rsrch

Rapid City, South Dakota, United States

LifeDoc Health

Memphis, Tennessee, United States

Amir Ali Hassan, MD, PA

Houston, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

UVA Health Systems

Charlottesville, Virginia, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Centro de Investigaciones Metabólicas

Capital Federal, Buenos Aires, Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

IMOBA

City of Buenos Aires, Argentina

CIPADI

Godoy Cruz, Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca

San Miguel de Tucumán, Argentina

Hospital Universitário Walter Cantídio

Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil

Centro de Diabetes Curitiba

Curitiba, Paraná, Brazil

Instituto da Criança com Diabetes - ICD

Porto Alegre, Rio Grande do Sul, 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, Brazil

IBTED Tecnologia e Educação em Diabetes - EPP

São Paulo, São Paulo, Brazil

Instituto da Criança e do Adolescente do HCFMUSP

São Paulo, São Paulo, Brazil

Salud SURA Industriales

Bogotá, Antioquia, Colombia

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, India

BAPS Pramukh Swami Hospital

Surat, Gujarat, India

Indira Gandhi Institute of child health

Bangalore, Karnataka, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Maulana Azad Medical College

Delhi, New Delhi, India

Regency Hospital

Kanpur, Uttar Pradesh, India

Institute of Child Health

Kolkata, West Bengal, India

Excel Endocrine Centre

Kolhāpur, India

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

HaEmek MC - Pediatric Endocrinology department

Afula, Israel

Soroka MC - Pediatric Endocrinology

Beersheba, Israel

Rambam MC - Department of Pediatrics A

Haifa, Israel

Carmel MC - Pediatric Endocrinology Unit

Haifa, Israel

Shaare Zedek MC - Pediatric Endocrinology

Jerusalem, Israel

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

Hospital Putrajaya

Putrajaya, Malaysia

Instituto Nacional de Pediatría

Coyoacán, Mexico City, Mexico

IECSI Centro de Investigación Clínica

Monterrey, Nuevo León, Mexico

Centro de Investigación y Control Metabólico S. C.

San Nicolás de los Garza, Nuevo León, Mexico

UMAE CMN Siglo XXI Dept Endocrinología Pediátrica

Cuauhtémoc, Mexico

Consultorio de Endocrinología y Pediatría

Puebla City, Mexico

Taipei Mackay Children's Hospital

Taipei, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

Chiang Mai, Thailand

View Full Details on ClinicalTrials.gov

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NCT07282613

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