RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT07282613

Registry updated: 2026-10-19

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Description

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.

Interventions

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

Eligibility criteria

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.

Conditions

Diabetes Mellitus, Type 2

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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