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New combo shot CagriSema takes on childhood diabetes

NCT ID NCT07282613

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests a once-weekly injection called CagriSema (a mix of cagrilintide and semaglutide) in 80 children and adolescents with type 2 diabetes. The goal is to see if it lowers blood sugar and body weight better than a placebo. The trial lasts about 15 months, with everyone getting CagriSema in the second part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CagriSema (cagrilintide and semaglutide)
What this could lead to
If it works, this could offer a new treatment option to help children and teens with type 2 diabetes better control their blood sugar and weight.
What could go wrong
This is a Phase 3 trial, but it's small (80 participants) and results may not apply to all children. Side effects from the drugs are possible, and the placebo-controlled phase means some kids won't get the active treatment initially.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • All India Institute of Medical Sciences (AIIMS)

    NOT_YET_RECRUITING

    New Delhi, 110029, India

  • Amir Ali Hassan, MD, PA

    RECRUITING

    Houston, Texas, 77089, United States

  • BAPS Pramukh Swami Hospital

    NOT_YET_RECRUITING

    Surat, Gujarat, 395009, India

  • CIPADI

    NOT_YET_RECRUITING

    Godoy Cruz, M5501ARP, Argentina

  • Carmel MC - Pediatric Endocrinology Unit

    RECRUITING

    Haifa, 3436212, Israel

  • Centro de Diabetes Curitiba

    RECRUITING

    Curitiba, Paraná, 80810-040, Brazil

  • Centro de Investigaciones Metabólicas

    RECRUITING

    Capital Federal, Buenos Aires, C1056ABI, Argentina

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

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000DPX, Argentina

  • Centro de Investigación y Control Metabólico S. C.

    NOT_YET_RECRUITING

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

  • Children's Hosptl Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Research Trials of Florida

    RECRUITING

    Tampa, Florida, 33607, United States

  • Clínica Mayo de Urgencias Médicas Cruz Blanca

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • Columbus Research Foundation

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Consano Clinical Research, LLC

    RECRUITING

    Shavano Park, Texas, 78231, United States

  • Consultorio de Endocrinología y Pediatría

    NOT_YET_RECRUITING

    Puebla City, 72190, Mexico

  • D&H National Research Centers

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Eastside Bariatric and Gen Surg

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Encore Medical Research Boynton Beach

    RECRUITING

    Boynton Beach, Florida, 33436, United States

  • Endolife Specialty Hospitals

    NOT_YET_RECRUITING

    Guntur, Andhra Pradesh, 522001, India

  • Excel Endocrine Centre

    NOT_YET_RECRUITING

    Kolhāpur, 416008, India

  • Fundacion Valle del Lili

    NOT_YET_RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Great Lakes Research Inst.

    RECRUITING

    Southfield, Michigan, 48075, United States

  • HaEmek MC - Pediatric Endocrinology department

    RECRUITING

    Afula, 1834111, Israel

  • Hospital Putrajaya

    RECRUITING

    Putrajaya, 62250, Malaysia

  • Hospital Universitário Walter Cantídio

    NOT_YET_RECRUITING

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

  • IBTED Tecnologia e Educação em Diabetes - EPP

    RECRUITING

    São Paulo, São Paulo, 04038-032, Brazil

  • IECSI Centro de Investigación Clínica

    NOT_YET_RECRUITING

    Monterrey, Nuevo León, 64310, Mexico

  • IMOBA

    RECRUITING

    City of Buenos Aires, C1056ABH, Argentina

  • Indira Gandhi Institute of child health

    NOT_YET_RECRUITING

    Bangalore, Karnataka, 560011, India

  • Innovus Clinical

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Institute of Child Health

    NOT_YET_RECRUITING

    Kolkata, West Bengal, 700017, India

  • Instituto Nacional de Pediatría

    NOT_YET_RECRUITING

    Coyoacán, Mexico City, 04530, Mexico

  • Instituto da Criança com Diabetes - ICD

    NOT_YET_RECRUITING

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

  • Instituto da Criança e do Adolescente do HCFMUSP

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • King Chulalongkorn Memorial Hospital

    RECRUITING

    Bangkok, 10330, Thailand

  • LifeDoc Health

    RECRUITING

    Memphis, Tennessee, 38115, United States

  • Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Maulana Azad Medical College

    NOT_YET_RECRUITING

    Delhi, New Delhi, 110002, India

  • Monument Health Clinical Rsrch

    NOT_YET_RECRUITING

    Rapid City, South Dakota, 57701, United States

  • NYU Langone Orthopedic Center

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Nemours Chld Clnc Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Rambam MC - Department of Pediatrics A

    RECRUITING

    Haifa, 31096, Israel

  • Regency Hospital

    NOT_YET_RECRUITING

    Kanpur, Uttar Pradesh, 208006, India

  • Riley Hospital For Children

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • SIU Medicine

    NOT_YET_RECRUITING

    Springfield, Illinois, 62702, United States

  • Salud SURA Industriales

    NOT_YET_RECRUITING

    Bogotá, Antioquia, 50017, Colombia

  • Seattle Children's Research Institute

    RECRUITING

    Seattle, Washington, 98105, United States

  • Shaare Zedek MC - Pediatric Endocrinology

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sir Ganga Ram Hospital

    NOT_YET_RECRUITING

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

  • Soroka MC - Pediatric Endocrinology

    RECRUITING

    Beersheba, 84101, Israel

  • Taipei Mackay Children's Hospital

    NOT_YET_RECRUITING

    Taipei, 104, Taiwan

  • UBMD Pediatrics

    NOT_YET_RECRUITING

    Buffalo, New York, 14203, United States

  • UMAE CMN Siglo XXI Dept Endocrinología Pediátrica

    NOT_YET_RECRUITING

    Cuauhtémoc, 06720, Mexico

  • UVA Health Systems

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    NOT_YET_RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • University Malaya Medical Centre

    RECRUITING

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Yale School of Medicine

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06511, United States

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