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)
Change in glycated haemoglobin (HbA1c) — From baseline (week 0) to end of double-blinded treatment (week 26) Measured as percentage (%) of HbA1c.
Trial sites (58)
Facility
City
Region
Status
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.
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.
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