Diabetes Mellitus, Type 2Phase 3REIMAGINEYOUNGNCT07282613
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
A Phase 3 study testing CagriSema (Cagrilintide B and Semaglutide I) in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 58 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CagriSema (Cagrilintide B and Semaglutide I)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 58 sitesin 10 countries
- Study dates
- 4 Aug 2026to 30 Mar 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
58 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
58 sites in 10 countries
United States21 sites, 21 recruiting
- Recruiting
Encore Medical Research Boynton Beach
Boynton Beach, Florida, 33436
- Not yet recruiting
UBMD Pediatrics
Buffalo, New York, 14203
- Recruiting
UVA Health Systems
Charlottesville, Virginia, 22903
- Recruiting
Columbus Research Foundation
Columbus, Georgia, 31904
- Recruiting
Amir Ali Hassan, MD, PA
Houston, Texas, 77089
- Not yet recruiting
Riley Hospital For Children
Indianapolis, Indiana, 46202
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, 32207
- Recruiting
Innovus Clinical
Kissimmee, Florida, 34741
- Recruiting
LifeDoc Health
Memphis, Tennessee, 38115
- Not yet recruiting
Yale School of Medicine
New Haven, Connecticut, 06511
- Not yet recruiting
NYU Langone Orthopedic Center
New York, New York, 10016
- Not yet recruiting
Children's Hosptl Philadelphia
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98105
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
- Recruiting
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078
- Recruiting
Great Lakes Research Inst.
Southfield, Michigan, 48075
- Not yet recruiting
SIU Medicine
Springfield, Illinois, 62702
- Recruiting
D&H National Research Centers
Tamarac, Florida, 33321
- Recruiting
Clinical Research Trials of Florida
Tampa, Florida, 33607
India9 sites, 9 recruiting
- Not yet recruiting
Indira Gandhi Institute of child health
Bangalore, Karnataka, 560011
- Not yet recruiting
Maulana Azad Medical College
Delhi, New Delhi, 110002
- Not yet recruiting
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
- Not yet recruiting
Regency Hospital
Kanpur, Uttar Pradesh, 208006
- Not yet recruiting
Excel Endocrine Centre
Kolhāpur, 416008
- Not yet recruiting
Institute of Child Health
Kolkata, West Bengal, 700017
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Not yet recruiting
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029
- Not yet recruiting
BAPS Pramukh Swami Hospital
Surat, Gujarat, 395009
Brazil6 sites, 6 recruiting
- Recruiting
Hospital Universitário Walter Cantídio
Bairro Rodolfo Teófilo, Fortaleza, Ceará, 60416-000
- Recruiting
Centro de Diabetes Curitiba
Curitiba, Paraná, 80810-040
- Not yet recruiting
Instituto da Criança com Diabetes - ICD
Porto Alegre, Rio Grande do Sul, 91350-250
- 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, 14051-140
- Recruiting
IBTED Tecnologia e Educação em Diabetes - EPP
São Paulo, São Paulo, 04038-032
- Recruiting
Instituto da Criança e do Adolescente do HCFMUSP
São Paulo, São Paulo, 05403-000
Argentina5 sites, 5 recruiting
- Recruiting
Centro de Investigaciones Metabólicas
Capital Federal, Buenos Aires, C1056ABI
- Recruiting
IMOBA
City of Buenos Aires, C1056ABH
- Not yet recruiting
CIPADI
Godoy Cruz, M5501ARP
- Recruiting
Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
San Miguel de Tucumán, Tucumán Province, T4000DPX
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca
San Miguel de Tucumán, T4000IHE
Israel5 sites, 5 recruiting
- Recruiting
HaEmek MC - Pediatric Endocrinology department
Afula, 1834111
- Recruiting
Soroka MC - Pediatric Endocrinology
Beersheba, 84101
- Recruiting
Rambam MC - Department of Pediatrics A
Haifa, 31096
- Recruiting
Carmel MC - Pediatric Endocrinology Unit
Haifa, 3436212
- Recruiting
Shaare Zedek MC - Pediatric Endocrinology
Jerusalem, 9103102
Mexico5 sites, 5 recruiting
- Not yet recruiting
Instituto Nacional de Pediatría
Coyoacán, Mexico City, 04530
- Not yet recruiting
UMAE CMN Siglo XXI Dept Endocrinología Pediátrica
Cuauhtémoc, 06720
- Not yet recruiting
IECSI Centro de Investigación Clínica
Monterrey, Nuevo León, 64310
- Not yet recruiting
Consultorio de Endocrinología y Pediatría
Puebla City, 72190
- Not yet recruiting
Centro de Investigación y Control Metabólico S. C.
San Nicolás de los Garza, Nuevo León, 66465
Colombia2 sites, 2 recruiting
- Not yet recruiting
Salud SURA Industriales
Bogotá, Antioquia, 50017
- Not yet recruiting
Fundacion Valle del Lili
Cali, Valle del Cauca Department, 760032
Malaysia2 sites, 2 recruiting
- Recruiting
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
- Recruiting
Hospital Putrajaya
Putrajaya, 62250
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
- Recruiting
Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology
Chiang Mai, 50200
Taiwan1 site, 1 recruiting
- Not yet recruiting
Taipei Mackay Children's Hospital
Taipei, 104
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CagriSema (Cagrilintide B and Semaglutide I), Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagriSema (Cagrilintide B and Semaglutide I)Drug
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)Drug
Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: CagriSema | Experimental | Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. Receives: Drug: CagriSema (Cagrilintide B and Semaglutide I) |
| Part 1: Placebo | Placebo comparator | Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. Receives: Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) |
| Part 2: CagriSema | Experimental | Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2. Receives: Drug: CagriSema (Cagrilintide B and Semaglutide I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) of HbA1c.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Secondary outcomes (52)
Relative change in body mass index (BMI)
Measured as percentage.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in fasting plasma glucose
Measured as mmol/L.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Relative change in body weight
Measured as percentage of body weight.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in BMI standard deviation score (SDS)
Measured as score on scale.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in waist circumference
Measured as centimetre (cm).
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in waist-to-height ratio
Measured as ratio.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in systolic blood pressure
Measured as millimetre of mercury (mmHg).
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in diastolic blood pressure
Measured as mmHg.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: total cholesterol
Measured as ratio.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: triglycerides
Measured as ratio.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in lipid: Non-HDL cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in alanine aminotransferase (ALT)
Measured as units per liter (U/L).
Measured: 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).
Measured: 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).
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in insulin dose
Measured as units (U).
Measured: 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.
Measured: At end of double-blinded treatment (week 26)
Ratio to baseline in urine albumin-creatinine ratio (UACR)
Measured as ratio.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to end of double- blinded treatment (week 26)
Ratio to baseline in free fatty acids
Measured as ratio.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in leptin
Measured as ratio.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Ratio to baseline in soluble leptin receptor
Measured as ratio.
Measured: 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.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Change in aspartate aminotransferase (AST)
Measured as U/L.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Height velocity
Measured as cm/year.
Measured: At end of double-blinded treatment (week 26)
Change in height SDS
Measured as score on scale.
Measured: From baseline (week 0) to end of double-blinded treatment (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start4 Aug 2026
- Primary completion7 Sep 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282613
- Sponsor's protocol ID
- NN9388-7988
- Other IDs
- U1111-1307-6786, 2024-514432-24
- Acronym
- REIMAGINEYOUNG
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com