RecruitingPhase 3NCT07222137

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

Sponsor

Eli Lilly and Company

Enrollment

150 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

Eligibility

Min Age: 1 YearMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether baricitinib — a drug already approved for rheumatoid arthritis and other conditions — can delay or prevent the progression from early-stage type 1 diabetes (before full insulin dependence) to full-blown type 1 diabetes. It targets the immune system's attack on insulin-producing cells. **You may be eligible if...** - You have at least two type 1 diabetes-related antibodies in your blood (detected on at least two separate occasions) - You have been classified as having Stage 1b or Stage 2 type 1 diabetes (meaning your immune system is attacking your pancreas, but you don't yet have full diabetes) - You weigh at least 8 kg (18 pounds) **You may NOT be eligible if...** - You have any other type of diabetes - You have uncontrolled high blood pressure - You have had a heart attack, stroke, heart disease, or heart failure - You have a history of blood clots, lymphoma, or other cancers - You have a current or recent serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

Administered orally

DRUGPlacebo

Administered orally

Locations(107)

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States

University of South Florida

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Novak Center for Children's Health

Louisville, Kentucky, United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

Women's and Children's Hospital

Adelaide, Australia

Box Hill Hospital

Box Hill, Australia

Royal Brisbane and Women's Hospital

Brisbane, Australia

Centre for Children's Health Research

Brisbane, Australia

Royal Children's Hospital

Melbourne, Australia

The Royal Melbourne Hospital

Parkville, Australia

Perth Children's Hospital

Perth, Australia

Sydney Children's Hospital

Randwick, Australia

The Children's Hospital at Westmead

Westmead, Australia

UZ Brussel

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Leuven

Leuven, Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

Freire Pesquisa Clínica

Belo Horizonte, Brazil

Centro de Diabetes Curitiba

Curitiba, Brazil

Hospital Universitario Walter Cantidio

Fortaleza, Brazil

Cendi - Endocrinologia e Diabetes

Goiânia, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

Instituto de Pesquisa Clinica

São Paulo, Brazil

CPCLIN

São Paulo, Brazil

IBTED - Tecnologia e Educação em Diabetes

São Paulo, Brazil

Hospital das Clinicas FMUSP

São Paulo, Brazil

Alberta Diabetes Institute

Edmonton, Canada

BC Diabetes Office

Vancouver, Canada

Oulun yliopistollinen sairaala

Oulu, Finland

Tampereen yliopistollinen sairaala

Tampere, Finland

Turku University Hospital

Turku, Finland

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Hopital Claude Huriez - CHU de Lille

Lille, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, France

Pitie Salpetriere University Hospital

Paris, France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, France

Hôpital Universitaire Necker Enfants Malades

Paris, France

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

Paris, France

CHU Rangueil

Toulouse, France

Universitaetsklinikum Augsburg

Augsburg, Germany

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Germany

Hannoversche Kinderheilanstalt

Hanover, Germany

TUM Klinikum

München, Germany

Yitzhak Shamir Medical Center

Beer Yaacov, Israel

Soroka Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Institute of Diabetes, Technology and Research - Clalit Health

Herzliya, Israel

Hadassah Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center

Rehovot, Israel

Sourasky Medical Center

Tel Aviv, Israel

Ospedale Pediatrico Salesi

Ancona, Italy

IRCCS - AOU di Bologna

Bologna, Italy

Ospedale Microcitemico

Cagliari, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Italy

Ospedale San Raffaele

Milan, Italy

University of Naples Federico II

Naples, Italy

University of Naples Federico II

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Azienda Ospedale - Università Padova

Padova, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy

Abeno Medical Clinic

Abeno, Japan

Saitama Medical University Hospital

Iruma, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Japan

Yamanashi Prefectural Central Hospital

Kofu, Japan

Seino Internal Medicine Clinic

Kōriyama, Japan

Jinnouchi Hospital

Kumamoto, Japan

Nagano Municipal Hospital

Nagano, Japan

Soleil Chikusa Clinic

Nagoya, Japan

Nakakinen clinic

Naka, Japan

Niigata University Medical & Dental Hospital

Niigata, Japan

Diabeter - Rotterdam

Rotterdam, Netherlands

Haukeland Universitetssjukehus

Bergen, Norway

Akershus Universitetssykehus

Lørenskog, Norway

Oslo Universitetssykehus Ullevål

Oslo, Norway

Oslo Universitetssykehus Aker

Oslo, Norway

Stavanger Universitetssykehus

Stavanger, Norway

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

Warsaw, Poland

2Ca Braga

Braga, Portugal

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, Portugal

Centro Materno Infantil do Norte

Porto, Portugal

ULSAM - Hospital de Santa Luzia

Viana do Castelo, Portugal

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

Vila Nova de Gaia, Portugal

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Skånes Universitetssjukhus Malmö

Malmö, Sweden

Universitetssjukhuset Örebro

Örebro, Sweden

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Birmingham Children's Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Noah's Ark Children's Hospital for Wales

Cardiff, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Royal London Hospital

London, United Kingdom

St. George's Hospital

London, United Kingdom

The John Radcliffe Hospital

Oxford, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

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NCT07222137

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