A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
BARICADE-DELAY
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
3 other identifiers
interventional
150
18 countries
107
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2026
Longer than P75 for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2025
CompletedFirst Posted
Study publicly available on registry
October 29, 2025
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
April 17, 2026
April 1, 2026
5.5 years
October 27, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Baseline up to approximately 5 years
Secondary Outcomes (10)
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Baseline, Week 52
Change from Baseline in Glucose AUC
Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Baseline, Week 52
Change from Baseline in Height
Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile
Baseline, Week 52
- +5 more secondary outcomes
Study Arms (2)
Baricitinib
EXPERIMENTALParticipants will receive baricitinib orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (107)
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
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
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
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
Soleil Chikusa Clinic
Nagoya, 464-0858, 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
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
Malmo, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2025
First Posted
October 29, 2025
Study Start
January 12, 2026
Primary Completion (Estimated)
July 1, 2031
Study Completion (Estimated)
July 1, 2031
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.