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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NN9388-7988U1111-1307-67862024-514432-24
• Study Type: interventional
• Target: 80
• Locations: 10 countries
• Sites: 55

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured as percentage (%) of HbA1c.

  From baseline (week 0) to end of double-blinded treatment (week 26)

Secondary Outcomes (52)

• Relative change in body mass index (BMI)

  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])

  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)

  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)

  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

  From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)

Study Arms (3)

Part 1: CagriSema

EXPERIMENTAL

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

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.

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.

Drug: CagriSema (Cagrilintide B and Semaglutide I)

Interventions

CagriSema (Cagrilintide B and Semaglutide I) DRUG

Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Part 1: CagriSema; Part 2: CagriSema

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.

Part 1: Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (55)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Encore Medical Research Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, 32207, United States

Location

Innovus Clinical

Kissimmee, Florida, 34741, United States

Location

D&H National Research Centers

Tamarac, Florida, 33321, United States

Location

Clinical Research Trials of Florida

Tampa, Florida, 33607, United States

Location

Columbus Research Foundation

Columbus, Georgia, 31904, United States

Location

Eastside Bariatric and Gen Surg

Snellville, Georgia, 30078, United States

Location

SIU Medicine

Springfield, Illinois, 62702, United States

Location

Riley Hospital For Children

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Great Lakes Research Inst.

Southfield, Michigan, 48075, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Monument Health Clinical Rsrch

Rapid City, South Dakota, 57701, United States

Location

LifeDoc Health

Memphis, Tennessee, 38115, United States

Location

Amir Ali Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

UVA Health Systems

Charlottesville, Virginia, 22903, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98105, United States

Location

Centro de Investigaciones Metabólicas

Capital Federal, Buenos Aires, C1056ABI, Argentina

Location

Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio

San Miguel de Tucumán, Tucumán Province, T4000DPX, Argentina

Location

IMOBA

City of Buenos Aires, C1056ABH, Argentina

Location

Clínica Mayo de Urgencias Médicas Cruz Blanca

San Miguel de Tucumán, T4000IHE, Argentina

Location

Hospital Universitário Walter Cantídio

Bairro Rodolfo Teófilo, Fortaleza, Ceará, 60416-000, Brazil

Location

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810-040, Brazil

Location

Instituto da Criança com Diabetes - ICD

Porto Alegre, Rio Grande do Sul, 91350-250, Brazil

Location

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, Brazil

Location

Instituto da Criança e do Adolescente do HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Salud SURA Industriales

Bogotá, Antioquia, 50017, Colombia

Location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

Location

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

Location

BAPS Pramukh Swami Hospital

Surat, Gujarat, 395009, India

Location

Indira Gandhi Institute of child health

Bangalore, Karnataka, 560011, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Maulana Azad Medical College

Delhi, New Delhi, 110002, India

Location

Regency Hospital

Kanpur, Uttar Pradesh, 208006, India

Location

Institute of Child Health

Kolkata, West Bengal, 700017, India

Location

Excel Endocrine Centre

Kolhāpur, 416008, India

Location

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India

Location

HaEmek MC - Pediatric Endocrinology department

Afula, 1834111, Israel

Location

Soroka MC - Pediatric Endocrinology

Beersheba, 84101, Israel

Location

Rambam MC - Department of Pediatrics A

Haifa, 31096, Israel

Location

Carmel MC - Pediatric Endocrinology Unit

Haifa, 3436212, Israel

Location

Shaare Zedek MC - Pediatric Endocrinology

Jerusalem, 9103102, Israel

Location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Instituto Nacional de Pediatría

Coyoacán, Mexico City, 04530, Mexico

Location

IECSI Centro de Investigación Clínica

Monterrey, Nuevo León, 64310, Mexico

Location

Centro de Investigación y Control Metabólico S. C.

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

Consultorio de Endocrinología y Pediatría

Puebla City, 72190, Mexico

Location

Taipei Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is 2-part study, first part is double-blinded and second part is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): September 7, 2029
• Study Completion (Estimated): March 30, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

MY (2); CO (2); TW (1); TH (2); IL (5); BR (5); AR (4); US (21); ME (4); IN (9)