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NCT07222332PHASE3Recruiting

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

Eli Lilly and Company

Start Date

2/5/2026

Completion Date

7/1/2028

Summary

The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.

Eligibility Criteria

Age Range: 1 years to 35 years

Inclusion Criteria: * Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention * Have at least one diabetes-related autoantibody found at screening * Show signs of remaining beta-cell function * stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening * Weigh at least 8 kilograms (kg) (18 pounds) at screening Exclusion Criteria: * Have any other type of diabetes including gestational * 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 medical condition or 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

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado 80045

United States

Tallahassee Memorial HealthCare

Tallahassee, Florida 32308

United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania 19104

United States

Driscoll Children's Hospital

Corpus Christi, Texas 78411

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Women's and Children's Hospital

Adelaide, 5006

Australia

Centre for Children's Health Research

Brisbane, 4101

Australia

Austin Health - Repatriation Hospital

Heidelberg West, 3081

Australia

Ipswich Hospital

Ipswich, 4305

Australia

Royal Children's Hospital

Melbourne, 3052

Australia

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, 5046

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

Université Libre de Bruxelles - Hôpital Erasme

Brussels, 1070

Belgium

UZ Brussel

Brussels, 1090

Belgium

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

Antwerp University Hospital

Edegem, 2650

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, 5000

Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

Yvoir, 5530

Belgium

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, 79080-190

Brazil

Quanta Diagnóstico e Terapia

Curitiba, 80045170

Brazil

Centro de Diabetes Curitiba

Curitiba, 80810-040

Brazil

Centro De Diabetes Metabolismo E Endocrinologia

Fortaleza, 60175-047

Brazil

Cendi - Endocrinologia e Diabetes

Goiânia, 74230-035

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Instituto da Crianca com Diabetes

Porto Alegre, 91350-250

Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T

Ribeirão Preto, 14051-140

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

Clínica Hepatogastro JK

São Paulo, 04077-020

Brazil

Hospital das Clinicas FMUSP

São Paulo, 05403-000

Brazil

CEDOES

Vitória, 29055450

Brazil

Alberta Children's Hospital

Calgary, T3B 6A8

Canada

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, G7H 5H6

Canada

Alberta Diabetes Institute

Edmonton, T6G 2E1

Canada

St. Joseph's Health Care

London, N6A 4V2

Canada

Centricity Research Ottawa LMC Endocrinology

Ottawa, K2J 0V2

Canada

CHUL et Centre mère-enfant Soleil

Québec, G1V 4G2

Canada

BC Diabetes Office

Vancouver, V5Y 3W2

Canada

Nemocnice Jihlava

Jihlava, 58633

Czechia

Fakultni nemocnice Ostrava

Ostrava, 70852

Czechia

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, 14900

Czechia

New Children's Hospital

Helsinki, 00029

Finland

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

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38700

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

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

Hannoversche Kinderheilanstalt

Hanover, 30173

Germany

Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel

Hof, 95030

Germany

Klinikum Karlsburg

Karlsburg, 17495

Germany

Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

Ludwigshafen am Rhein, 67059

Germany

TUM Klinikum

München, 80939

Germany

RED-Institut GmbH

Oldenburg, 23758

Germany

Asklepios Klinik Sankt Augustin

Sankt Augustin, 53757

Germany

Universitaetsklinikum Ulm

Ulm, 89075

Germany

Yitzhak Shamir Medical Center

Beer Yaacov, 70300

Israel

Soroka Medical Center

Beersheba, 8410101

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Linn Medical Center

Haifa, 3515209

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

Sourasky Medical Center

Tel Aviv, 6423906

Israel

Ospedale Pediatrico Salesi

Ancona, 60123

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, 50139

Italy

Azienda Ospedaliera Universitaria Di Messina G. Martino

Messina, 98125

Italy

Ospedale San Raffaele

Milan, 20132

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 Ospedale - Università Padova

Padova, 35128

Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, 37126

Italy

Saitama Medical University Hospital

Iruma, 350-0495

Japan

Shiga General Hospital

Moriyama, 524-8524

Japan

Abeno Medical Clinic

Osaka, 545-0052

Japan

Shizuoka Children's Hospital

Shizuoka, 420-8660

Japan

Diabeter - Rotterdam

Rotterdam, 3011 TA

Netherlands

Helse Fonna - Haugesund Sjukehus

Haugesund, 5528

Norway

Akershus Universitetssykehus

Lørenskog, 1478

Norway

Oslo Universitetssykehus Aker

Oslo, 0316

Norway

Oslo Universitetssykehus Ullevål

Oslo, 0450

Norway

Stavanger Universitetssykehus

Stavanger, 4011

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952

Poland

UMED Clinical Trials

Lodz, 92-213

Poland

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, 50-368

Poland

2Ca Braga

Braga, 4710-243

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 Clínic de Barcelona

Barcelona, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

ProbarE i Lund AB

Lund, 222 22

Sweden

Universitetssjukhuset Örebro

Örebro, 701 85

Sweden

Östersunds Sjukhus

Östersund, 831 31

Sweden

ProbarE i Stockholm AB

Stockholm, 11437

Sweden

Uddevalla Sjukhus

Uddevalla, 451 53

Sweden

Institute of Endocrinology and Metabolism named after Komissarenko

Kiev, 04114

Ukraine

Kyiv City Endocrinological Center

Kyiv, 01024

Ukraine

Zakarpattia Endoclinic

Uzhhorod, 88000

Ukraine

Vinnytsia Regional Clinical Endocrinology Dispensary

Vinnytsia, 21010

Ukraine

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN

United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH

United Kingdom

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Southmead Hospital

Bristol, BS10 5NB

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 2QQ

United Kingdom

University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom

Churchill Hospital

Oxford, OX3 7LE

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom