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Could a pill delay diabetes in kids? new trial hopes so

NCT ID NCT07222137

Prevention Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 10 times

Summary

This study tests whether the drug baricitinib can delay the onset of type 1 diabetes in children aged 1 to 36 months who are at high risk. Participants take baricitinib or a placebo daily for up to 5 years. The goal is to see if the drug can push back or prevent the need for insulin treatment.

What this could mean

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

Active substance
baricitinib
What this could lead to
If successful, this could provide a way to delay or prevent type 1 diabetes in children at high risk, potentially avoiding lifelong insulin dependence.
What could go wrong
This is an early phase 3 trial with only 150 participants, so results may not apply to everyone. Baricitinib is an immunosuppressant and may have side effects like increased infection risk.

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 150 people

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

Started

Jan 2026

Expected to finish

Jul 2031

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

1 year to 35 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.

Inclusion Criteria: * Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening * Have Stage 1b or Stage 2 type 1 diabetes * Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening Exclusion Criteria: * Have any other type of diabetes * Have uncontrolled high blood pressure * Have had a heart attack, heart disease, stroke, or heart failure * Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy * Have a current or recent clinically serious infection

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus, type 1

How to take part

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

  1. The places running it

    113 sites in 19 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • 2Ca Braga

    RECRUITING

    Braga, 4710-243, Portugal

  • Abeno Medical Clinic

    RECRUITING

    Abeno, 545-0052, Japan

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 2QQ, United Kingdom

  • Akershus Universitetssykehus

    RECRUITING

    Lørenskog, 1478, Norway

  • Alberta Children's Hospital

    NOT_YET_RECRUITING

    Calgary, T3B 6A8, Canada

  • Alberta Diabetes Institute

    NOT_YET_RECRUITING

    Edmonton, T6G 2E1, Canada

  • Antwerp University Hospital

    RECRUITING

    Edegem, 2650, Belgium

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T

    NOT_YET_RECRUITING

    Paris, 75019, France

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    NOT_YET_RECRUITING

    Marseille, 13385, France

  • Azienda Ospedale - Università Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    RECRUITING

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    RECRUITING

    Florence, 50139, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    RECRUITING

    Novara, 28100, Italy

  • BC Diabetes Office

    RECRUITING

    Vancouver, V5Y 3W2, Canada

  • Birmingham Children's Hospital

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Box Hill Hospital

    RECRUITING

    Box Hill, 3128, Australia

  • CHU Rangueil

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • CHU UCL Namur/Site Sainte Elisabeth

    NOT_YET_RECRUITING

    Namur, 5000, Belgium

  • CPCLIN

    RECRUITING

    São Paulo, 01228-200, Brazil

  • Carmel Hospital

    NOT_YET_RECRUITING

    Haifa, 3436212, Israel

  • Cendi - Endocrinologia e Diabetes

    RECRUITING

    Goiânia, 74230-035, Brazil

  • Centre Hospitalier Sud Francilien

    NOT_YET_RECRUITING

    Corbeil-Essonnes, 91106, France

  • Centre for Children's Health Research

    RECRUITING

    Brisbane, 4101, Australia

  • Centro Materno Infantil do Norte

    RECRUITING

    Porto, 4050, Portugal

  • Centro de Diabetes Curitiba

    RECRUITING

    Curitiba, 80810-040, Brazil

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    RECRUITING

    Marília, 17504-072, Brazil

  • Children's Hospital of Philadelphia (CHOP)

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cliniques universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, 1200, Belgium

  • Diabeter - Rotterdam

    RECRUITING

    Rotterdam, 3011 TA, Netherlands

  • Freire Pesquisa Clínica

    RECRUITING

    Belo Horizonte, 30150-320, Brazil

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hannoversche Kinderheilanstalt

    RECRUITING

    Hanover, 30173, Germany

  • Haukeland Universitetssjukehus

    RECRUITING

    Bergen, 5021, Norway

  • Hopital Claude Huriez - CHU de Lille

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Hospices Civils de Lyon - Hopital Louis Pradel

    NOT_YET_RECRUITING

    Bron, 69677, France

  • Hospital Sant Joan de Déu

    RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Walter Cantidio

    RECRUITING

    Fortaleza, 60430-270, Brazil

  • Hospital das Clinicas FMUSP

    RECRUITING

    São Paulo, 05403-000, Brazil

  • Hôpital Universitaire Necker Enfants Malades

    NOT_YET_RECRUITING

    Paris, 75015, France

  • IBTED - Tecnologia e Educação em Diabetes

    RECRUITING

    São Paulo, 04038-032, Brazil

  • IRCCS - AOU di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Institute of Diabetes, Technology and Research - Clalit Health

    RECRUITING

    Herzliya, 4600201, Israel

  • Instituto de Pesquisa Clinica

    RECRUITING

    São Paulo, 01223-001, Brazil

  • Iowa Diabetes and Endocrinology Research Center

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • Jinnouchi Hospital

    RECRUITING

    Kumamoto, 862-0976, Japan

  • Kaplan Medical Center

    RECRUITING

    Rehovot, 7610001, Israel

  • Klinik Josefinum

    NOT_YET_RECRUITING

    Augsburg, 86154, Germany

  • MTZ Clinical Research Powered by Pratia

    NOT_YET_RECRUITING

    Warsaw, 02-172, Poland

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    RECRUITING

    Warsaw, 04-501, Poland

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Nagano Municipal Hospital

    RECRUITING

    Nagano, 381-8551, Japan

  • Nakakinen clinic

    RECRUITING

    Naka, 311-0113, Japan

  • Niigata University Medical & Dental Hospital

    RECRUITING

    Niigata, 951-8520, Japan

  • Nippon Medical School Musashi Kosugi Hospital

    RECRUITING

    Kawasaki, 211-8533, Japan

  • Noah's Ark Children's Hospital for Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Novak Center for Children's Health

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Oslo Universitetssykehus Aker

    RECRUITING

    Oslo, 0586, Norway

  • Oslo Universitetssykehus Ullevål

    RECRUITING

    Oslo, 0450, Norway

  • Ospedale Microcitemico

    NOT_YET_RECRUITING

    Cagliari, 09121, Italy

  • Ospedale Pediatrico Salesi

    RECRUITING

    Ancona, 60123, Italy

  • Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Oulun yliopistollinen sairaala

    RECRUITING

    Oulu, 90220, Finland

  • Perth Children's Hospital

    RECRUITING

    Perth, 6009, Australia

  • Pitie Salpetriere University Hospital

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Queen Elizabeth University Hospital

    NOT_YET_RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Brisbane, 4029, Australia

  • Royal Children's Hospital

    NOT_YET_RECRUITING

    Melbourne, 3052, Australia

  • Royal London Hospital

    RECRUITING

    London, E1 1BB, United Kingdom

  • Saitama Medical University Hospital

    RECRUITING

    Iruma, 350-0495, Japan

  • Sansum Diabetes Research Institute

    NOT_YET_RECRUITING

    Santa Barbara, California, 93105, United States

  • Schneider Children's Medical Center

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Seino Internal Medicine Clinic

    RECRUITING

    Kōriyama, 963-8851, Japan

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Sheba Medical Center

    NOT_YET_RECRUITING

    Ramat Gan, 5262100, Israel

  • Skånes Universitetssjukhus Malmö

    RECRUITING

    Malmö, 21428, Sweden

  • Soroka Medical Center

    RECRUITING

    Beersheba, 8410101, Israel

  • Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Southampton General Hospital

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • St. George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • Stavanger Universitetssykehus

    RECRUITING

    Stavanger, 4011, Norway

  • Sydney Children's Hospital

    RECRUITING

    Randwick, 2031, Australia

  • TUM Klinikum

    RECRUITING

    München, 80939, Germany

  • Tallahassee Memorial HealthCare

    RECRUITING

    Tallahassee, Florida, 32308, United States

  • Tampereen yliopistollinen sairaala

    RECRUITING

    Tampere, 33520, Finland

  • The Children's Hospital at Westmead

    RECRUITING

    Westmead, 2145, Australia

  • The John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • The Royal Melbourne Hospital

    RECRUITING

    Parkville, 3050, Australia

  • Turku University Hospital

    RECRUITING

    Turku, 20520, Finland

  • ULSAM - Hospital de Santa Luzia

    RECRUITING

    Viana do Castelo, 4900-858, Portugal

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Unidade Local De Saude De Gaia/Espinho E.P.E.

    NOT_YET_RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

  • Unidade Local de Saude de Matosinhos

    RECRUITING

    Matosinhos Municipality, 4464-513, Portugal

  • Universidade Federal do Rio de Janeiro

    RECRUITING

    Rio de Janeiro, 21941-590, Brazil

  • Universitaetsklinikum Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Universitetssjukhuset Örebro

    RECRUITING

    Örebro, 701 85, Sweden

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University Medical Centre Ljubljana

    NOT_YET_RECRUITING

    Ljubljana, 1000, Slovenia

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Naples Federico II

    RECRUITING

    Naples, 80100, Italy

  • University of Naples Federico II

    RECRUITING

    Naples, 80131, Italy

  • University of South Florida

    SUSPENDED

    Tampa, Florida, 33612, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Women's and Children's Hospital

    RECRUITING

    Adelaide, 5006, Australia

  • Yamanashi Prefectural Central Hospital

    RECRUITING

    Kofu, 400-8506, Japan

  • Yitzhak Shamir Medical Center

    RECRUITING

    Beer Yaacov, 70300, Israel

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