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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 · Novo Nordisk A/S
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Official title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes
About this study
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 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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult
Timeline
Starts: 2026-08-04
Estimated completion: 2030-03-30
Last updated: 2026-09-09
Interventions
Drug: CagriSema (Cagrilintide B and Semaglutide I)Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Primary outcomes
  • Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of double-blinded treatment (week 26))
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency dept. 2834 · study_director, Novo Nordisk A/S
All locations (58)
Yale School of MedicineNot Yet Recruiting
New Haven, Connecticut, United States
Encore Medical Research Boynton BeachRecruiting
Boynton Beach, Florida, United States
Nemours Chld Clnc JacksonvilleRecruiting
Jacksonville, Florida, United States
Innovus ClinicalRecruiting
Kissimmee, Florida, United States
D&H National Research CentersRecruiting
Tamarac, Florida, United States
Clinical Research Trials of FloridaRecruiting
Tampa, Florida, United States
Columbus Research FoundationRecruiting
Columbus, Georgia, United States
Eastside Bariatric and Gen SurgRecruiting
Snellville, Georgia, United States
SIU MedicineNot Yet Recruiting
Springfield, Illinois, United States
Riley Hospital For ChildrenNot Yet Recruiting
Indianapolis, Indiana, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Great Lakes Research Inst.Recruiting
Southfield, Michigan, United States
UBMD PediatricsNot Yet Recruiting
Buffalo, New York, United States
NYU Langone Orthopedic CenterNot Yet Recruiting
New York, New York, United States
Children's Hosptl PhiladelphiaNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Monument Health Clinical RsrchNot Yet Recruiting
Rapid City, South Dakota, United States
LifeDoc HealthRecruiting
Memphis, Tennessee, United States
Amir Ali Hassan, MD, PARecruiting
Houston, Texas, United States
Consano Clinical Research, LLCRecruiting
Shavano Park, Texas, United States
UVA Health SystemsRecruiting
Charlottesville, Virginia, United States
Seattle Children's Research InstituteRecruiting
Seattle, Washington, United States
Centro de Investigaciones MetabólicasRecruiting
Capital Federal, Buenos Aires, Argentina
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de JulioRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
IMOBARecruiting
City of Buenos Aires, Argentina
CIPADINot Yet Recruiting
Godoy Cruz, Argentina
Clínica Mayo de Urgencias Médicas Cruz BlancaRecruiting
San Miguel de Tucumán, Argentina
Hospital Universitário Walter CantídioNot Yet Recruiting
Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil
Centro de Diabetes CuritibaRecruiting
Curitiba, Paraná, Brazil
Instituto da Criança com Diabetes - ICDNot Yet Recruiting
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 PauloNot Yet Recruiting
Ribeirão Preto, São Paulo, Brazil
IBTED Tecnologia e Educação em Diabetes - EPPRecruiting
São Paulo, São Paulo, Brazil
Instituto da Criança e do Adolescente do HCFMUSPRecruiting
São Paulo, São Paulo, Brazil
Salud SURA IndustrialesNot Yet Recruiting
Bogotá, Antioquia, Colombia
Fundacion Valle del LiliNot Yet Recruiting
Cali, Valle del Cauca Department, Colombia
Endolife Specialty HospitalsNot Yet Recruiting
Guntur, Andhra Pradesh, India
BAPS Pramukh Swami HospitalNot Yet Recruiting
Surat, Gujarat, India
Indira Gandhi Institute of child healthNot Yet Recruiting
Bangalore, Karnataka, India
Sir Ganga Ram HospitalNot Yet Recruiting
New Delhi, National Capital Territory of Delhi, India
Maulana Azad Medical CollegeNot Yet Recruiting
Delhi, New Delhi, India
Regency HospitalNot Yet Recruiting
Kanpur, Uttar Pradesh, India
Institute of Child HealthNot Yet Recruiting
Kolkata, West Bengal, India
Excel Endocrine CentreNot Yet Recruiting
Kolhāpur, India
All India Institute of Medical Sciences (AIIMS)Not Yet Recruiting
New Delhi, India
HaEmek MC - Pediatric Endocrinology departmentRecruiting
Afula, Israel
Soroka MC - Pediatric EndocrinologyRecruiting
Beersheba, Israel
Rambam MC - Department of Pediatrics ARecruiting
Haifa, Israel
Carmel MC - Pediatric Endocrinology UnitRecruiting
Haifa, Israel
Shaare Zedek MC - Pediatric EndocrinologyRecruiting
Jerusalem, Israel
University Malaya Medical CentreRecruiting
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital PutrajayaRecruiting
Putrajaya, Malaysia
Instituto Nacional de PediatríaNot Yet Recruiting
Coyoacán, Mexico City, Mexico
IECSI Centro de Investigación ClínicaNot Yet Recruiting
Monterrey, Nuevo León, Mexico
Centro de Investigación y Control Metabólico S. C.Not Yet Recruiting
San Nicolás de los Garza, Nuevo León, Mexico
UMAE CMN Siglo XXI Dept Endocrinología PediátricaNot Yet Recruiting
Cuauhtémoc, Mexico
Consultorio de Endocrinología y PediatríaNot Yet Recruiting
Puebla City, Mexico
Taipei Mackay Children's HospitalNot Yet Recruiting
Taipei, Taiwan
King Chulalongkorn Memorial HospitalRecruiting
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital_Pediatric EndocrinologyRecruiting
Chiang Mai, Thailand