Diabetes Mellitus, Type 1Phase 3BARICADE-DELAYNCT07222137
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
A Phase 3 study testing Baricitinib in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 112 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 35 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 112 sitesin 19 countries
- Study dates
- 12 Jan 2026to Jul 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
112 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
112 sites in 19 countries
Israel13 sites, 13 recruiting
- Recruiting
Yitzhak Shamir Medical Center
Beer Yaacov, 70300
97289542166
Marianna Rachmiel
- Recruiting
Soroka Medical Center
Beersheba, 8410101
97286244150
Alon Haim
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
97247774411
Ram Weiss
- Recruiting
Carmel Hospital
Haifa, 3436212
Inbal Halabi
- Recruiting
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, 4600201
972-9-9613210
Eytan Roitman
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
+972-507874590
Gil Leibowitz
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
972-97472559
Victor Vishlitzky
- Recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
97239253282
Moshe Phillip
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
+97239377183
Idit Dotan
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
+972035302021
Amir Tirosh
- Not yet recruiting
Sheba Medical Center
Ramat Gan, 5262100
035308469
Noah Gruber
- Recruiting
Kaplan Medical Center
Rehovot, 7610001
+9728-9441361
Alena Kirzhner
- Recruiting
Sourasky Medical Center
Tel Aviv, 6423906
97236974863
Yael Lebenthal
Brazil10 sites, 10 recruiting
- Recruiting
Freire Pesquisa Clínica
Belo Horizonte, 30150-320
Flávia Maia
- Recruiting
Centro de Diabetes Curitiba
Curitiba, 80810-040
554130231252
André Vianna
- Recruiting
Hospital Universitario Walter Cantidio
Fortaleza, 60430-270
Renan Montenegro
- Recruiting
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035
5562992240229
Nelson Rassi
- Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
55 14 21051477
José Sgarbi
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941-590
Melanie Rodacki
- Recruiting
Instituto de Pesquisa Clinica
São Paulo, 01223-001
551127370277
Joao Salles
- Recruiting
CPCLIN
São Paulo, 01228-200
551126303777
Denise Franco
- Recruiting
IBTED - Tecnologia e Educação em Diabetes
São Paulo, 04038-032
551197116-9844
Monica Gabbay
- Recruiting
Hospital das Clinicas FMUSP
São Paulo, 05403-000
Maria Elizabeth Rossi da Silva
Italy10 sites, 10 recruiting
- Recruiting
Ospedale Pediatrico Salesi
Ancona, 60123
390715962011
Valentino Cherubini
- Recruiting
IRCCS - AOU di Bologna
Bologna, 40138
0512143009
Guido Di Dalmazi
- Not yet recruiting
Ospedale Microcitemico
Cagliari, 09121
+39 070 52965605
Carlo Ripoli
- Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
3384034476
Lorenzo Lenzi
- Not yet recruiting
Ospedale San Raffaele
Milan, 20132
0226432818
Emanuele Bosi
- Recruiting
University of Naples Federico II
Naples, 80100
+390817462311
Lutgarda Bozzetto
- Recruiting
University of Naples Federico II
Naples, 80131
Enza Mozzillo
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
3903213733350
Ivana Rabbone
- Recruiting
Azienda Ospedale - Università Padova
Padova, 35128
3357940960
Carlo Moretti
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
0458127662
Claudio Maffeis
United Kingdom10 sites, 10 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
parth narendran
- Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
Renuka Dias
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 2QQ
+44 1223 336994
Mark Evans
- Recruiting
Noah's Ark Children's Hospital for Wales
Cardiff, CF14 4XW
02920742274
Ambika Shetty
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
Maitrayee Choudhury
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Rajeeb Rashid
- Recruiting
Royal London Hospital
London, E1 1BB
Ruben Willemsen
- Recruiting
St. George's Hospital
London, SW17 0QT
07885278793
Mimi Chen
- Recruiting
The John Radcliffe Hospital
Oxford, OX3 9DU
01865231729
Rachel Besser
- Recruiting
Southampton General Hospital
Southampton, SO16 6YD
02381208518
Nicola Trevelyan
Australia9 sites, 9 recruiting
- Recruiting
Women's and Children's Hospital
Adelaide, 5006
Jennifer Couper
- Recruiting
Box Hill Hospital
Box Hill, 3128
Ming Li Yee
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, 4029
+61736468111
Donald McLeod
- Recruiting
Centre for Children's Health Research
Brisbane, 4101
Tony Huynh
- Recruiting
Royal Children's Hospital
Melbourne, 3052
Fergus Cameron
- Recruiting
The Royal Melbourne Hospital
Parkville, 3050
John Wentworth
- Recruiting
Perth Children's Hospital
Perth, 6009
Elizabeth Davis
- Recruiting
Sydney Children's Hospital
Randwick, 2031
Kristen Neville
- Recruiting
The Children's Hospital at Westmead
Westmead, 2145
02 9845 3171
Ann Maguire
France9 sites, 9 recruiting
- Not yet recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677
33472129525
Marc Nicolino
- Not yet recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
33161693086
Alfred Penfornis
- Not yet recruiting
Hopital Claude Huriez - CHU de Lille
Lille, 59037
Anne VAMBERGUE
- Not yet recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385
33 491388384
Rachel Reynaud
- Not yet recruiting
Pitie Salpetriere University Hospital
Paris, 75013
Chloé AMOUYAL
- Not yet recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
Roberto Mallone
- Not yet recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
01 44 49 48 01
Alix BESANCON
- Not yet recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, 75019
33140032000
Elise Bismuth
- Not yet recruiting
CHU Rangueil
Toulouse, 31059
33 5 61 32 30 18
Pierre Gourdy
Japan9 sites, 9 recruiting
- Recruiting
Abeno Medical Clinic
Abeno, 545-0052
81120023812
Tomoyuki Kawamura
- Recruiting
Saitama Medical University Hospital
Iruma, 350-0495
81120023812
Yoichi Oikawa
- Recruiting
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, 211-8533
81120023812
Hanako Tajima
- Recruiting
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
81120023812
Masaharu Inoue
- Recruiting
Seino Internal Medicine Clinic
Kōriyama, 963-8851
81120023812
Hiroaki Seino
- Recruiting
Jinnouchi Hospital
Kumamoto, 862-0976
81120023812
Hideaki Jinnouchi
- Recruiting
Nagano Municipal Hospital
Nagano, 381-8551
81120023812
ASAMI SANO
- Recruiting
Nakakinen clinic
Naka, 311-0113
81120023812
Takeshi Osonoi
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
81120023812
Yohei Ogawa
United States7 sites, 7 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Aaron Misakian
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
319-356-4511
Michael Tansey
- Not yet recruiting
Novak Center for Children's Health
Louisville, Kentucky, 40202
502-629-5820
Kupper Wintergerst
- Not yet recruiting
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
267-426-7037
Steven Willi
- Not yet recruiting
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
805-682-7638
Kristin Castorino
- Recruiting
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
850-431-5404
Larry Deeb
- Recruiting
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
515-329-6800
Anuj Bhargava
Belgium5 sites, 5 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
0475956681
Willem Staels
- Not yet recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
3227647052
Philippe Lysy
- Recruiting
Antwerp University Hospital
Edegem, 2650
0032 8214364
Christophe De Block
- Recruiting
UZ Leuven
Leuven, 3000
+3216346994
Chantal Mathieu
- Recruiting
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000
+32-81-720505
Dominique Beckers
Germany5 sites, 5 recruiting
- Not yet recruiting
Klinik Josefinum
Augsburg, 86154
00498212412200
Thomas Völkl
- Recruiting
Universitaetsklinikum Augsburg
Augsburg, 86156
00498214009201
Desiree Dunstheimer
- Not yet recruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, 01307
03514587510
Gita Gemulla
- Recruiting
Hannoversche Kinderheilanstalt
Hanover, 30173
004951181153331
Olga Kordonouri
- Recruiting
TUM Klinikum
München, 80939
0049 89 3187 2896
Anette Ziegler
Norway5 sites, 5 recruiting
- Recruiting
Haukeland Universitetssjukehus
Bergen, 5021
Henrik Irgens
- Recruiting
Akershus Universitetssykehus
Lørenskog, 1478
Christopher Inchley
- Recruiting
Oslo Universitetssykehus Ullevål
Oslo, 0450
+4797522277
Lars Krogvold
- Recruiting
Oslo Universitetssykehus Aker
Oslo, 0586
Kari Anne Sveen
- Recruiting
Stavanger Universitetssykehus
Stavanger, 4011
Sondre Meling
Portugal5 sites, 5 recruiting
- Recruiting
2Ca Braga
Braga, 4710-243
Ana Sofia Martins
- Recruiting
Unidade Local de Saude de Matosinhos
Matosinhos Municipality, 4464-513
Rosa Maria Príncipe
- Recruiting
Centro Materno Infantil do Norte
Porto, 4050
+351914125573
Teresa Maria da Silva Borges Ferreira
- Recruiting
ULSAM - Hospital de Santa Luzia
Viana do Castelo, 4900-858
961790293
Maria Cristina Roque
- Not yet recruiting
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, 4434-502
Marta Ferreira
Canada3 sites, 3 recruiting
- Not yet recruiting
Alberta Children's Hospital
Calgary, T3B 6A8
Carol Huang
- Not yet recruiting
Alberta Diabetes Institute
Edmonton, T6G 2E1
Peter Senior
- Recruiting
BC Diabetes Office
Vancouver, V5Y 3W2
604-683-3734 x 1001
Thomas Elliott
Finland3 sites, 3 recruiting
- Recruiting
Oulun yliopistollinen sairaala
Oulu, 90220
Riitta Veijola
- Recruiting
Tampereen yliopistollinen sairaala
Tampere, 33520
358503539956
Sauli Palmu
- Recruiting
Turku University Hospital
Turku, 20520
Jorma Toppari
Spain3 sites, 3 recruiting
- Recruiting
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903
946006000
NANCY PORTILLO NAJERA
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
Roque Cardona-Hernandez
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
+34621360800
Lía Nattero Chávez
Poland2 sites, 2 recruiting
- Not yet recruiting
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Agnieszka Szypowska
- Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501
+48502056191
EDYTA JABLONSKA-WYPUSTEK
Sweden2 sites, 2 recruiting
- Recruiting
Skånes Universitetssjukhus Malmö
Malmö, 21428
Helena Elding Larsson
- Recruiting
Universitetssjukhuset Örebro
Örebro, 701 85
Frida Sundberg
Netherlands1 site, 1 recruiting
- Recruiting
Diabeter - Rotterdam
Rotterdam, 3011 TA
+31-88-280-7277
Hendrik Aanstoot
Slovenia1 site, 1 recruiting
- Not yet recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Tadej Battelino
About this study
Official title: 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
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Participants will receive baricitinib orally Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Measured: Baseline up to approximately 5 years
Secondary outcomes (10)
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Measured: Baseline, Week 52
Change from Baseline in Glucose AUC
Measured: Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Measured: Baseline, Week 52
Change from Baseline in Height
Measured: Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile
Measured: Baseline, Week 52
Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive)
Measured: Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Measured: Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Measured: Predose through Week 24
PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Measured: Predose through Week 24
Change from Baseline in Matsuda Index
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start12 Jan 2026
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222137
- Sponsor's protocol ID
- 27404
- Other IDs
- 2025-521797-34-00, I4V-MC-JAJJ, 2025
- Acronym
- BARICADE-DELAY
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.