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
Recruiting · NCT07282613 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
CagriSema (Cagrilintide B and Semaglutide I)Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
What this trial is about
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.
Who can take part
Age range
10 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
58 locations listed across 14 US states.
- 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
- HaEmek MC - Pediatric Endocrinology department - Afula, Israel
- King Chulalongkorn Memorial Hospital - Bangkok, Thailand
- Soroka MC - Pediatric Endocrinology - Beersheba, Israel
- Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology - Chiang Mai, Thailand
- IMOBA - City of Buenos Aires, Argentina
- UMAE CMN Siglo XXI Dept Endocrinología Pediátrica - Cuauhtémoc, Mexico
- CIPADI - Godoy Cruz, Argentina
- Rambam MC - Department of Pediatrics A - Haifa, Israel
- Carmel MC - Pediatric Endocrinology Unit - Haifa, Israel
- Shaare Zedek MC - Pediatric Endocrinology - Jerusalem, Israel
- Excel Endocrine Centre - Kolhāpur, India
- All India Institute of Medical Sciences (AIIMS) - New Delhi, India
- Consultorio de Endocrinología y Pediatría - Puebla City, Mexico
- Hospital Putrajaya - Putrajaya, Malaysia
- Clínica Mayo de Urgencias Médicas Cruz Blanca - San Miguel de Tucumán, Argentina
- Taipei Mackay Children's Hospital - Taipei, Taiwan
- Endolife Specialty Hospitals - Guntur, Andhra Pradesh, India
- Salud SURA Industriales - Bogotá, Antioquia, Colombia
- Centro de Investigaciones Metabólicas - Capital Federal, Buenos Aires, Argentina
- Hospital Universitário Walter Cantídio - Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil
- BAPS Pramukh Swami Hospital - Surat, Gujarat, India
- Indira Gandhi Institute of child health - Bangalore, Karnataka, India
- University Malaya Medical Centre - Lembah Pantai, Kuala Lumpur, Malaysia
- Instituto Nacional de Pediatría - Coyoacán, Mexico City, Mexico
- Sir Ganga Ram Hospital - New Delhi, National Capital Territory of Delhi, India
- Maulana Azad Medical College - Delhi, New Delhi, India
- 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
- 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
- Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio - San Miguel de Tucumán, Tucumán Province, Argentina
- Regency Hospital - Kanpur, Uttar Pradesh, India
- Fundacion Valle del Lili - Cali, Valle del Cauca Department, Colombia
- Institute of Child Health - Kolkata, West Bengal, India