A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
NCT ID: NCT07222332
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2026-03-31
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baricitinib
Participants will receive baricitinib orally
Baricitinib
Administered orally
Placebo
Participants will receive placebo orally
Placebo
Administered orally
Interventions
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Baricitinib
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, or
* random C-peptide result \>0.3 nmol/L (0.9 ng/mL) during the screening period
* Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion Criteria
* 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
1 Year
35 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Women's and Children's Hospital
Adelaide, , Australia
Centre for Children's Health Research
Brisbane, , Australia
Austin Health - Repatriation Hospital
Heidelberg West, , Australia
Ipswich Hospital
Ipswich, , Australia
Royal Children's Hospital
Melbourne, , Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, , 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
Université Libre de Bruxelles - Hôpital Erasme
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, , Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, , Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, , Belgium
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, , Brazil
Quanta Diagnóstico e Terapia
Curitiba, , Brazil
Centro de Diabetes Curitiba
Curitiba, , Brazil
Centro De Diabetes Metabolismo E Endocrinologia
Fortaleza, , Brazil
Cendi - Endocrinologia e Diabetes
Goiânia, , Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, , Brazil
Instituto da Crianca com Diabetes
Porto Alegre, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
Ribeirão Preto, , 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
Clínica Hepatogastro JK
São Paulo, , Brazil
Hospital das Clinicas FMUSP
São Paulo, , Brazil
CEDOES
Vitória, , Brazil
Alberta Children's Hospital
Calgary, , Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, , Canada
Alberta Diabetes Institute
Edmonton, , Canada
St. Joseph's Health Care
London, , Canada
CHUL et Centre mère-enfant Soleil
Québec, , Canada
BC Diabetes Office
Vancouver, , Canada
Nemocnice Jihlava
Jihlava, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, , Czechia
New Children's Hospital
Helsinki, , Finland
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
Centre Hospitalier Universitaire de Grenoble
Grenoble, , 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
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
Hannoversche Kinderheilanstalt
Hanover, , Germany
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
Hof, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, , Germany
TUM Klinikum
München, , Germany
RED-Institut GmbH
Oldenburg, , Germany
Christliches Krankenhaus Quakenbrück
Quakenbrück, , Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Yitzhak Shamir Medical Center
Beer Yaacov, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Linn Medical Center
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
Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, , Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, , Italy
Ospedale San Raffaele
Milan, , Italy
University of Naples Federico II
Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, , Italy
Azienda Ospedale - Università Padova
Padua, , Italy
Azienda Ospedale - Università Padova
Padua, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, , Italy
Diabeter - Rotterdam
Rotterdam, , Netherlands
Helse Fonna - Haugesund Sjukehus
Haugesund, , Norway
Akershus Universitetssykehus
Lørenskog, , Norway
Oslo Universitetssykehus Aker
Oslo, , Norway
Oslo Universitetssykehus Ullevål
Oslo, , Norway
Stavanger Universitetssykehus
Stavanger, , Norway
St. Olavs Hospital
Trondheim, , Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
UMED Clinical Trials
Lodz, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, , Poland
2Ca Braga
Braga, , 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 Clínic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
ProbarE i Lund AB
Lund, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Östersunds Sjukhus
Östersund, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
CTC MTC
Uppsala, , Sweden
Institute of Endocrinology and Metabolism named after Komissarenko
Kiev, , Ukraine
Kyiv City Endocrinological Center
Kyiv, , Ukraine
Zakarpattia Endoclinic
Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Endocrinology Dispensary
Vinnytsia, , Ukraine
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Facility Contacts
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Related Links
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A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Other Identifiers
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2025-522170-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
I4V-MC-JAJK
Identifier Type: OTHER
Identifier Source: secondary_id
27405
Identifier Type: -
Identifier Source: org_study_id
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