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NCT07222137PHASE3Recruiting

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

Eli Lilly and Company

Start Date

1/12/2026

Completion Date

7/1/2031

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 Criteria

Age Range: 1 years to 35 years

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

Interventions

DRUG

Baricitinib

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Diabetes Mellitus, Type 1

Locations

Tallahassee Memorial HealthCare

Tallahassee, Florida 32308

United States

University of South Florida

Tampa, Florida 33612

United States

University of Iowa

Iowa City, Iowa 52242

United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa 50266

United States

Novak Center for Children's Health

Louisville, Kentucky 40202

United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania 19104

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Women's and Children's Hospital

Adelaide, 5006

Australia

Box Hill Hospital

Box Hill, 3128

Australia

Royal Brisbane and Women's Hospital

Brisbane, 4029

Australia

Centre for Children's Health Research

Brisbane, 4101

Australia

Royal Children's Hospital

Melbourne, 3052

Australia

The Royal Melbourne Hospital

Parkville, 3050

Australia

Perth Children's Hospital

Perth, 6009

Australia

Sydney Children's Hospital

Randwick, 2031

Australia

The Children's Hospital at Westmead

Westmead, 2145

Australia

UZ Brussel

Brussels, 1090

Belgium

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

Antwerp University Hospital

Edegem, 2650

Belgium

UZ Leuven

Leuven, 3000

Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, 5000

Belgium

Freire Pesquisa Clínica

Belo Horizonte, 30150-320

Brazil

Centro de Diabetes Curitiba

Curitiba, 80810-040

Brazil

Hospital Universitario Walter Cantidio

Fortaleza, 60430-270

Brazil

Cendi - Endocrinologia e Diabetes

Goiânia, 74230-035

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941-590

Brazil

Instituto de Pesquisa Clinica

São Paulo, 01223-001

Brazil

CPCLIN

São Paulo, 01228-200

Brazil

IBTED - Tecnologia e Educação em Diabetes

São Paulo, 04038-032

Brazil

Hospital das Clinicas FMUSP

São Paulo, 05403-000

Brazil

Alberta Diabetes Institute

Edmonton, T6G 2E1

Canada

BC Diabetes Office

Vancouver, V5Y 3W2

Canada

Oulun yliopistollinen sairaala

Oulu, 90220

Finland

Tampereen yliopistollinen sairaala

Tampere, 33520

Finland

Turku University Hospital

Turku, 20520

Finland

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, 69677

France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106

France

Hopital Claude Huriez - CHU de Lille

Lille, 59037

France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, 13385

France

Pitie Salpetriere University Hospital

Paris, 75013

France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, 75014

France

Hôpital Universitaire Necker Enfants Malades

Paris, 75015

France

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

Paris, 75019

France

CHU Rangueil

Toulouse, 31059

France

Klinik Josefinum

Augsburg, 86154

Germany

Universitaetsklinikum Augsburg

Augsburg, 86156

Germany

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, 01307

Germany

Hannoversche Kinderheilanstalt

Hanover, 30173

Germany

TUM Klinikum

München, 80939

Germany

Yitzhak Shamir Medical Center

Beer Yaacov, 70300

Israel

Soroka Medical Center

Beersheba, 8410101

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Carmel Hospital

Haifa, 3436212

Israel

Institute of Diabetes, Technology and Research - Clalit Health

Herzliya, 4600201

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Schneider Children's Medical Center

Petah Tikva, 4920235

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Kaplan Medical Center

Rehovot, 7610001

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

Ospedale Pediatrico Salesi

Ancona, 60123

Italy

IRCCS - AOU di Bologna

Bologna, 40138

Italy

Ospedale Microcitemico

Cagliari, 09121

Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, 50139

Italy

Ospedale San Raffaele

Milan, 20132

Italy

University of Naples Federico II

Naples, 80100

Italy

University of Naples Federico II

Naples, 80131

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100

Italy

Azienda Ospedale - Università Padova

Padova, 35128

Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, 37126

Italy

Abeno Medical Clinic

Abeno, 545-0052

Japan

Saitama Medical University Hospital

Iruma, 350-0495

Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, 211-8533

Japan

Yamanashi Prefectural Central Hospital

Kofu, 400-8506

Japan

Seino Internal Medicine Clinic

Kōriyama, 963-8851

Japan

Jinnouchi Hospital

Kumamoto, 862-0976

Japan

Nagano Municipal Hospital

Nagano, 381-8551

Japan

Nakakinen clinic

Naka, 311-0113

Japan

Niigata University Medical & Dental Hospital

Niigata, 951-8520

Japan

Diabeter - Rotterdam

Rotterdam, 3011 TA

Netherlands

Haukeland Universitetssjukehus

Bergen, 5021

Norway

Akershus Universitetssykehus

Lørenskog, 1478

Norway

Oslo Universitetssykehus Ullevål

Oslo, 0450

Norway

Oslo Universitetssykehus Aker

Oslo, 0586

Norway

Stavanger Universitetssykehus

Stavanger, 4011

Norway

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172

Poland

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

Warsaw, 04-501

Poland

2Ca Braga

Braga, 4710-243

Portugal

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, 4464-513

Portugal

Centro Materno Infantil do Norte

Porto, 4050

Portugal

ULSAM - Hospital de Santa Luzia

Viana do Castelo, 4900-858

Portugal

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

Vila Nova de Gaia, 4434-502

Portugal

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, 48903

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Skånes Universitetssjukhus Malmö

Malmö, 21428

Sweden

Universitetssjukhuset Örebro

Örebro, 701 85

Sweden

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH

United Kingdom

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 2QQ

United Kingdom

Noah's Ark Children's Hospital for Wales

Cardiff, CF14 4XW

United Kingdom

University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom

Queen Elizabeth University Hospital

Glasgow, G51 4TF

United Kingdom

Royal London Hospital

London, E1 1BB

United Kingdom

St. George's Hospital

London, SW17 0QT

United Kingdom

The John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom