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

Last updated: July 3, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 1

Treatment

Baricitinib

Placebo

Clinical Study ID

NCT07222332
27405
I4V-MC-JAJK
2025-522170-36-00
  • Ages 1-35
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Have a new diagnosis of type 1 diabetes within 100 days prior to starting studyintervention

  • 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

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 diseaseor malignancy

  • Have a current or recent clinically serious medical condition or infection

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Baricitinib
Phase: 3
Study Start date:
February 05, 2026
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Women's and Children's Hospital

    Adelaide, 5006
    Australia

    Active - Recruiting

  • Centre for Children's Health Research

    Brisbane, 4101
    Australia

    Site Not Available

  • Austin Health - Repatriation Hospital

    Heidelberg West, 3081
    Australia

    Active - Recruiting

  • Ipswich Hospital

    Ipswich, 4305
    Australia

    Active - Recruiting

  • Royal Children's Hospital

    Melbourne, 3052
    Australia

    Site Not Available

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, 5046
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Parkville, 3050
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth, 6009
    Australia

    Active - Recruiting

  • Sydney Children's Hospital

    Randwick, 2031
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead, 2145
    Australia

    Active - Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels 2800866, 1070
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000
    Belgium

    Site Not Available

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

    Yvoir, 5530
    Belgium

    Site Not Available

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, 79080-190
    Brazil

    Active - Recruiting

  • Centro de Diabetes Curitiba

    Curitiba, 80810-040
    Brazil

    Active - Recruiting

  • Quanta Diagnóstico e Terapia

    Curitiba, 80045170
    Brazil

    Active - Recruiting

  • Quanta Diagnóstico e Terapia

    Curitiba 3464975, 80045170
    Brazil

    Site Not Available

  • Centro De Diabetes Metabolismo E Endocrinologia

    Fortaleza, 60175-047
    Brazil

    Active - Recruiting

  • Cendi - Endocrinologia e Diabetes

    Goiânia, 74230-035
    Brazil

    Active - Recruiting

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    Marília, 17504-072
    Brazil

    Active - Recruiting

  • Instituto da Crianca com Diabetes

    Porto Alegre, 91350-250
    Brazil

    Active - Recruiting

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

    Ribeirão Preto, 14051-140
    Brazil

    Site Not Available

  • Universidade Federal do Rio de Janeiro

    Rio de Janeiro, 21941-590
    Brazil

    Active - Recruiting

  • CPCLIN

    São Paulo, 01228-200
    Brazil

    Active - Recruiting

  • Clínica Hepatogastro JK

    São Paulo, 04077-020
    Brazil

    Active - Recruiting

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • IBTED - Tecnologia e Educação em Diabetes

    São Paulo, 04038-032
    Brazil

    Active - Recruiting

  • Instituto de Pesquisa Clinica

    São Paulo, 01223-001
    Brazil

    Active - Recruiting

  • Clínica Hepatogastro JK

    São Paulo 3448439, 04543-011
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

  • IBTED - Tecnologia e Educação em Diabetes

    São Paulo 3448439, 04038-032
    Brazil

    Site Not Available

  • Instituto de Pesquisa Clinica

    São Paulo 3448439, 01223-001
    Brazil

    Site Not Available

  • CEDOES

    Vitória, 29055450
    Brazil

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary, T3B 6A8
    Canada

    Site Not Available

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, G7H 5H6
    Canada

    Site Not Available

  • Alberta Diabetes Institute

    Edmonton, T6G 2E1
    Canada

    Site Not Available

  • St. Joseph's Health Care

    London, N6A 4V2
    Canada

    Site Not Available

  • Centricity Research Ottawa LMC Endocrinology

    Ottawa, K2J 0V2
    Canada

    Active - Recruiting

  • CHUL et Centre mère-enfant Soleil

    Québec, G1V 4G2
    Canada

    Site Not Available

  • BC Diabetes Office

    Vancouver, V5Y 3W2
    Canada

    Active - Recruiting

  • Nemocnice Jihlava

    Jihlava, 58633
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, 70852
    Czechia

    Active - Recruiting

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900
    Czechia

    Active - Recruiting

  • New Children's Hospital

    Helsinki, 00029
    Finland

    Site Not Available

  • Oulun yliopistollinen sairaala

    Oulu, 90220
    Finland

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, 33520
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, 20520
    Finland

    Active - Recruiting

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38700
    France

    Site Not Available

  • Hopital Claude Huriez - CHU de Lille

    Lille, 59037
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, 13385
    France

    Site Not Available

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

    Paris, 75019
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Pitie Salpetriere University Hospital

    Paris, 75013
    France

    Site Not Available

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

    Paris 2988507, 75019
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris 2988507, 75015
    France

    Site Not Available

  • CHU Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Hannoversche Kinderheilanstalt

    Hanover, 30173
    Germany

    Site Not Available

  • Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel

    Hof, 95030
    Germany

    Active - Recruiting

  • Klinikum Karlsburg

    Karlsburg, 17495
    Germany

    Site Not Available

  • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

    Ludwigshafen am Rhein, 67059
    Germany

    Active - Recruiting

  • TUM Klinikum

    München, 80939
    Germany

    Active - Recruiting

  • RED-Institut GmbH

    Oldenburg, 23758
    Germany

    Active - Recruiting

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89075
    Germany

    Active - Recruiting

  • Yitzhak Shamir Medical Center

    Beer Yaacov, 70300
    Israel

    Active - Recruiting

  • Soroka Medical Center

    Beersheba, 8410101
    Israel

    Active - Recruiting

  • Linn Medical Center

    Haifa, 3515209
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Linn Medical Center

    Haifa 294801, 3515209
    Israel

    Site Not Available

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, 4600201
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, 4920235
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva 293918, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Ospedale Pediatrico Salesi

    Ancona, 60123
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence 3176959, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Di Messina G. Martino

    Messina, 98125
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • University of Naples Federico II

    Naples, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Active - Recruiting

  • Azienda Ospedale - Università Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedale - Università Padova

    Padua, 35128
    Italy

    Site Not Available

  • Azienda Ospedale - Università Padova

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, 37126
    Italy

    Active - Recruiting

  • Saitama Medical University Hospital

    Iruma, 350-0495
    Japan

    Site Not Available

  • Diabeter - Rotterdam

    Rotterdam, 3011 TA
    Netherlands

    Site Not Available

  • Helse Fonna - Haugesund Sjukehus

    Haugesund, 5528
    Norway

    Active - Recruiting

  • Akershus Universitetssykehus

    Lørenskog, 1478
    Norway

    Active - Recruiting

  • Oslo Universitetssykehus Aker

    Oslo, 0316
    Norway

    Active - Recruiting

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450
    Norway

    Active - Recruiting

  • Oslo Universitetssykehus Aker

    Oslo 3143244, 0316
    Norway

    Site Not Available

  • Stavanger Universitetssykehus

    Stavanger, 4011
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Active - Recruiting

  • UMED Clinical Trials

    Lodz, 92-213
    Poland

    Active - Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-368
    Poland

    Active - Recruiting

  • 2Ca Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Centro Materno Infantil do Norte

    Porto, 4050
    Portugal

    Site Not Available

  • ULSAM - Hospital de Santa Luzia

    Viana do Castelo, 4900-858
    Portugal

    Active - Recruiting

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

    Vila Nova de Gaia, 4434-502
    Portugal

    Site Not Available

  • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • ProbarE i Lund AB

    Lund, 222 22
    Sweden

    Site Not Available

  • ProbarE i Stockholm AB

    Stockholm, 11437
    Sweden

    Active - Recruiting

  • ProbarE i Stockholm AB

    Stockholm 2673730, 113 29
    Sweden

    Site Not Available

  • Uddevalla Sjukhus

    Uddevalla, 451 53
    Sweden

    Site Not Available

  • Universitetssjukhuset Örebro

    Örebro, 701 85
    Sweden

    Active - Recruiting

  • Östersunds Sjukhus

    Östersund, 831 31
    Sweden

    Site Not Available

  • Institute of Endocrinology and Metabolism named after Komissarenko

    Kiev, 04114
    Ukraine

    Active - Recruiting

  • Kyiv City Endocrinological Center

    Kyiv, 01024
    Ukraine

    Active - Recruiting

  • Zakarpattia Endoclinic

    Uzhhorod, 88000
    Ukraine

    Active - Recruiting

  • Vinnytsia Regional Clinical Endocrinology Dispensary

    Vinnytsia, 21010
    Ukraine

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham 2655603, B4 6NH
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 2QQ
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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