Clinical Trials in Brazil / NCT07282613
Recruiting Phase 3

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

NCT07282613 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 3
Started
2026-08-04
Last updated
2026-09-09

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

CagriSema (Cagrilintide B and Semaglutide I) →Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

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.

Study 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

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Yale School of Medicine New Haven Connecticut Not Yet Recruiting
Encore Medical Research Boynton Beach Boynton Beach Florida Recruiting
Nemours Chld Clnc Jacksonville Jacksonville Florida Recruiting
Innovus Clinical Kissimmee Florida Recruiting
D&H National Research Centers Tamarac Florida Recruiting
Clinical Research Trials of Florida Tampa Florida Recruiting
Columbus Research Foundation Columbus Georgia Recruiting
Eastside Bariatric and Gen Surg Snellville Georgia Recruiting
SIU Medicine Springfield Illinois Not Yet Recruiting
Riley Hospital For Children Indianapolis Indiana Not Yet Recruiting
University of Iowa Iowa City Iowa Recruiting
Great Lakes Research Inst. Southfield Michigan Recruiting
UBMD Pediatrics Buffalo New York Not Yet Recruiting
NYU Langone Orthopedic Center New York New York Not Yet Recruiting
Children's Hosptl Philadelphia Philadelphia Pennsylvania Not Yet Recruiting
Monument Health Clinical Rsrch Rapid City South Dakota Not Yet Recruiting
LifeDoc Health Memphis Tennessee Recruiting
Amir Ali Hassan, MD, PA Houston Texas Recruiting
Consano Clinical Research, LLC Shavano Park Texas Recruiting
UVA Health Systems Charlottesville Virginia Recruiting
Seattle Children's Research Institute Seattle Washington Recruiting
Centro de Investigaciones Metabólicas Capital Federal Buenos Aires Recruiting
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio San Miguel de Tucumán Tucumán Province Recruiting
IMOBA City of Buenos Aires Argentina Recruiting
CIPADI Godoy Cruz Argentina Not Yet Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca San Miguel de Tucumán Argentina Recruiting
Hospital Universitário Walter Cantídio Bairro Rodolfo Teófilo, Fortaleza Ceará Not Yet Recruiting
Centro de Diabetes Curitiba Curitiba Paraná Recruiting
Instituto da Criança com Diabetes - ICD Porto Alegre Rio Grande do Sul Not Yet Recruiting
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Ribeirão Preto São Paulo Not Yet Recruiting
IBTED Tecnologia e Educação em Diabetes - EPP São Paulo São Paulo Recruiting
Instituto da Criança e do Adolescente do HCFMUSP São Paulo São Paulo Recruiting
Salud SURA Industriales Bogotá Antioquia Not Yet Recruiting
Fundacion Valle del Lili Cali Valle del Cauca Department Not Yet Recruiting
Endolife Specialty Hospitals Guntur Andhra Pradesh Not Yet Recruiting
BAPS Pramukh Swami Hospital Surat Gujarat Not Yet Recruiting
Indira Gandhi Institute of child health Bangalore Karnataka Not Yet Recruiting
Sir Ganga Ram Hospital New Delhi National Capital Territory of Delhi Not Yet Recruiting
Maulana Azad Medical College Delhi New Delhi Not Yet Recruiting
Regency Hospital Kanpur Uttar Pradesh Not Yet Recruiting

+ 18 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07282613 on ClinicalTrials.gov ↗ ← All trials in Brazil