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 (REIMAGINEYOUNG)

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: CagriSema (Cagrilintide B and Semaglutide I); Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Argentina
  • City of Buenos Aires, Argentina, C1056ABH
    • IMOBA
  • San Miguel de Tucumán, Argentina, T4000IHE
    • Clínica Mayo de Urgencias Médicas Cruz Blanca
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, C1056ABI
      • Centro de Investigaciones Metabólicas
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000DPX
      • Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
• Brazil
  • Ceará
    • Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil, 60416-000
      • Hospital Universitario Walter Cantidio
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-040
      • Centro de Diabetes Curitiba
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-250
      • Instituto da Criança com Diabetes - ICD
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
    • São Paulo, São Paulo, Brazil, 05403-000
      • Instituto da Criança e do Adolescente do HCFMUSP
    • São Paulo, São Paulo, Brazil, 04038-032
      • IBTED Tecnologia e Educação em Diabetes - EPP
• Colombia
  • Antioquia
    • Bogotá, Antioquia, Colombia, 50017
      • Salud SURA Industriales
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundacion Valle del Lili
• India
  • Kolhāpur, India, 416008
    • Excel Endocrine Centre
  • New Delhi, India, 110029
    • All India Institute Of Medical Sciences (AIIMS)
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
  • Gujarat
    • Surat, Gujarat, India, 395009
      • BAPS Pramukh Swami Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560011
      • Indira Gandhi Institute of child health
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110060
      • Sir Ganga Ram Hospital
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Maulana Azad Medical College
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208006
      • Regency Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Institute of Child Health
• Israel
  • Afula, Israel, 1834111
    • HaEmek MC - Pediatric Endocrinology department
  • Beersheba, Israel, 84101
    • Soroka MC - Pediatric Endocrinology
  • Haifa, Israel, 31096
    • Rambam MC - Department of Pediatrics A
  • Haifa, Israel, 3436212
    • Carmel MC - Pediatric Endocrinology Unit
  • Jerusalem, Israel, 9103102
    • Shaare Zedek MC - Pediatric Endocrinology
• Malaysia
  • Putrajaya, Malaysia, 62250
    • Hospital Putrajaya
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
• Mexico
  • Puebla City, Mexico, 72190
    • Consultorio de Endocrinología y Pediatría
  • Mexico City
    • Coyoacán, Mexico City, Mexico, 04530
      • Instituto Nacional de Pediatría
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64310
      • IECSI Centro de Investigación Clínica
    • San Nicolás de los Garza, Nuevo León, Mexico, 66465
      • Centro de Investigación y Control Metabólico S. C.
• Taiwan
  • Taipei, Taiwan, 104
    • Taipei Mackay Children's Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale School of Medicine
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Encore Medical Research Boynton Beach
    • Jacksonville, Florida, United States, 32207
      • Nemours Chld Clnc Jacksonville
    • Kissimmee, Florida, United States, 34741
      • Innovus Clinical
    • Tamarac, Florida, United States, 33321
      • D&H National Research Centers
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Research Foundation
    • Snellville, Georgia, United States, 30078
      • Eastside Bariatric and Gen Surg
  • Illinois
    • Springfield, Illinois, United States, 62702
      • SIU Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Great Lakes Research Inst.
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Pediatrics
    • New York, New York, United States, 10016
      • NYU Langone Orthopedic Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hosptl Philadelphia
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Rsrch
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • LifeDoc Health
  • Texas
    • Houston, Texas, United States, 77089
      • Amir Ali Hassan, MD, PA
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Health Systems
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: CagriSema; Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.	Drug: CagriSema (Cagrilintide B and Semaglutide I); Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo Comparator: Part 1: Placebo; Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.	Drug: 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.
Experimental: 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.	Drug: CagriSema (Cagrilintide B and Semaglutide I); Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated haemoglobin (HbA1c)	Measured as percentage (%) of HbA1c.	From baseline (week 0) to end of double-blinded treatment (week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body mass index (BMI)	Measured as percentage.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with achievement of HbA1c target values of less than (<) 7.0% (< 53 millimole per mole [mmol/mol])	Measured as count of participants.	At end of double-blinded treatment (week 26)
Number of participants with achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤48 mmol/mol)	Measured as count of participants.	At end of double-blinded treatment (week 26)
Change in time in range (TIR) 3.9-10.0 millimole per liter (mmol/L) (70-180 milligram per deciliter (mg/dL) measured using continuous glucose monitoring (CGM)	Measured as percentage of time.	From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Change in time in tight target range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) measured using CGM	Measured as percentage of time.	From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Change in time above range (TAR) greater than (>) 10.0 mmol/L (> 180 mg/dL) measured using CGM	Measured as percentage of time.	From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Change in TAR greater than (>) 13.9 mmol/L (> 250 mg/dL) measured using CGM	Measured as percentage of time.	From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)
Change in mean sensor glucose concentration measured by CGM	Measured as mmol/L.	From baseline (collected during week -3, -2 and -1) to end-of- double-blinded treatment (collected during week 22, 23, 24, and 25)
CGM: Within-day glycaemic variability (% coefficient of variation)	Measured as percentage.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with incidence of glycaemic rescue therapy	Measured as count of participants	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in fasting plasma glucose	Measured as mmol/L.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with achievement of greater than or equal to (≥) 5% BMI reduction	Measured as count of participants.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with achievement of ≥ 10% BMI reduction	Measured as count of participants.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with achievement of ≥ 15% BMI reduction	Measured as count of participants.	From baseline (week 0) to end of double-blinded treatment (week 26)
Relative change in body weight	Measured as percentage of body weight.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in BMI standard deviation score (SDS)	Measured as score on scale.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in waist circumference	Measured as centimetre (cm).	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in waist-to-height ratio	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in systolic blood pressure	Measured as millimetre of mercury (mmHg).	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in diastolic blood pressure	Measured as mmHg.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: total cholesterol	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: high density lipoprotein (HDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: low density lipoprotein (LDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: very low density lipoprotein (VLDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: triglycerides	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: Non-HDL cholesterol	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in alanine aminotransferase (ALT)	Measured as units per liter (U/L).	From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)
Apparent clearance (CL/F) of cagrilintide and semaglutide	Measured as liter per hour (L/h).	From baseline (week 0) to end of double-blinded treatment (week 26)
Average concentration (Cavg) of cagrilintide and semaglutide at steady state	Measured as nanomole per liter (nmol/L).	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in insulin dose	Measured as units (U).	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of participants with achievement of sustained insulin dose = 0 U	Measured as count of participants.	At end of double-blinded treatment (week 26)
Ratio to baseline in urine albumin-creatinine ratio (UACR)	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in biomarker related to glucose metabolism: fasting C-peptide	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in biomarker related to glucose metabolism: fasting insulin	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in biomarker related to glucose metabolism: fasting proinsulin	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in biomarker related to glucose metabolism: fasting glucagon	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)	Measured as ratio.	From baseline (week 0) to end of double- blinded treatment (week 26)
Ratio to baseline in free fatty acids	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in leptin	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in soluble leptin receptor	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in leptin to soluble leptin receptor ratio	Measured as ratio.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in aspartate aminotransferase (AST)	Measured as U/L.	From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)
Change in alkaline phosphatase (ALP)	Measured as U/L.	From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)
Change in bilirubin	Measured as U/L.	From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52)
Change in HbA1c	Measured as percentage of HbA1c.	From baseline (week 0) to end of extension phase treatment (week 52)
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL) confirmed by blood glucose [BG] meter)	Measured as count of episodes.	From baseline (week 0) to end of double-blinded treatment (week 26)
Number of severe hypoglycaemic episodes (level 3) - severe hypoglycaemia being defined as severe cognitive impairment requiring assistance by another person to administer carbohydrates, glucagon, or intravenous glucose	Measured as count of episodes.	From baseline (week 0) to end of double-blinded treatment (week 26)
Change in percentage of time below range (TBR) < 3.0 mmol/L (< 54 mg/dL) measured using CGM	Measured as percentage of time.	At end of double-blinded treatment (collected during week 22, 23, 24, and 25)
Change in TBR < 3.9 mmol/L (< 70 mg/dL) measured using CGM	Measured as percentage of time.	At end of double-blinded treatment (collected during week 22, 23, 24, and 25)
Number of treatment-emergent adverse events	Measured as count of events.	From baseline (week 0) to end of double-blinded treatment (week 26)
Height velocity	Measured as cm/year.	At end of double-blinded treatment (week 26)
Change in height SDS	Measured as score on scale.	From baseline (week 0) to end of double-blinded treatment (week 26)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): September 7, 2029
• Study Completion (Estimated): March 30, 2030

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9388-7988; U1111-1307-6786 (Other Identifier: World Health Organization (WHO)); 2024-514432-24 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No