A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
NCT ID: NCT07222137
Last Updated: 2025-12-24
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
150 participants
INTERVENTIONAL
2026-01-31
2031-07-31
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 Stage 1b or Stage 2 type 1 diabetes
* Have a body weight of ≥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 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Napoli, , Italy
University of Naples Federico II
Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, , Italy
Azienda Ospedale - Università Padova
Padua, , 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
Malmo, , 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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Related Links
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A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults (BARICADE-DELAY)
Other Identifiers
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2025-521797-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
I4V-MC-JAJJ
Identifier Type: OTHER
Identifier Source: secondary_id
27404
Identifier Type: -
Identifier Source: org_study_id