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
NCT ID: NCT07282613
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2026-08-04
2030-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: CagriSema
Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.
CagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Part 1: Placebo
Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.
Placebo 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.
Part 2: CagriSema
Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2.
CagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Interventions
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CagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo 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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
10 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency dept. 2834
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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 Health
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
Seattle Children's Research Institute
Seattle, Washington, United States
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Investigaciones Metabólicas
Capital Federal, , Argentina
IMOBA
City of Buenos Aires, , 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
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
Indira Gandhi Institute of child health
Bangalore, Karnataka, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Regency Hospital
Kanpur, Uttar Pradesh, India
Institute of Child Health
Kolkata, West Bengal, 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
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
Consultorio de Endocrinología y Pediatría
Puebla City, , Mexico
Taipei Mackay Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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U1111-1307-6786
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514432-24
Identifier Type: OTHER
Identifier Source: secondary_id
NN9388-7988
Identifier Type: -
Identifier Source: org_study_id
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