Actively Recruiting
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 Under 36 Years
Led by Eli Lilly and Company · Updated on 2026-06-04
150
Participants Needed
107
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether baricitinib can delay the onset of clinical type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study focuses on participants aged 1 to under 36 years who have early-stage T1D or related autoantibody markers. The goal is to understand if baricitinib can postpone the progression to stage 3 T1D over a study period lasting up to approximately five years. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study includes a double-blind design, meaning neither participants nor researchers know who is receiving the active drug or placebo. The research team will monitor participants for up to about five years to assess the time it takes to develop stage 3 T1D and other health measures. Throughout the study, participants will undergo various assessments including measurements of glucose-stimulated C-peptide, glucose levels, body measurements such as height and BMI percentile, and health surveys. Blood samples will be collected to analyze baricitinib levels and its effects on glucose metabolism. The primary outcome is the time from baseline until diagnosis of stage 3 T1D. Safety and health status will be closely observed during the study period.
CONDITIONS
Brief Title
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 68 kilograms (18 pounds) at screening
- Be aged between 1 and 35 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 5 years
Participants will receive baricitinib or placebo orally as part of the study treatment.
Trial Site Locations
Total: 107 locations
1
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States, 32308
Not Yet Recruiting
2
University of South Florida
Tampa, Florida, United States, 33612
Suspended
3
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
4
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
5
Novak Center for Children's Health
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
6
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
University of Virginia
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
8
Women's and Children's Hospital
Adelaide, Australia, 5006
Actively Recruiting
9
Box Hill Hospital
Box Hill, Australia, 3128
Actively Recruiting
10
Royal Brisbane and Women's Hospital
Brisbane, Australia, 4029
Not Yet Recruiting
11
Centre for Children's Health Research
Brisbane, Australia, 4101
Not Yet Recruiting
12
Royal Children's Hospital
Melbourne, Australia, 3052
Not Yet Recruiting
13
The Royal Melbourne Hospital
Parkville, Australia, 3050
Actively Recruiting
14
Perth Children's Hospital
Perth, Australia, 6009
Actively Recruiting
15
Sydney Children's Hospital
Randwick, Australia, 2031
Actively Recruiting
16
The Children's Hospital at Westmead
Westmead, Australia, 2145
Actively Recruiting
17
UZ Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
18
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
19
Antwerp University Hospital
Edegem, Belgium, 2650
Not Yet Recruiting
20
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
21
CHU UCL Namur/Site Sainte Elisabeth
Namur, Belgium, 5000
Not Yet Recruiting
22
Freire Pesquisa Clínica
Belo Horizonte, Brazil, 30150-320
Actively Recruiting
23
Centro de Diabetes Curitiba
Curitiba, Brazil, 80810-040
Actively Recruiting
24
Hospital Universitario Walter Cantidio
Fortaleza, Brazil, 60430-270
Actively Recruiting
25
Cendi - Endocrinologia e Diabetes
Goiânia, Brazil, 74230-035
Actively Recruiting
26
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Actively Recruiting
27
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-590
Actively Recruiting
28
Instituto de Pesquisa Clinica
São Paulo, Brazil, 01223-001
Actively Recruiting
29
CPCLIN
São Paulo, Brazil, 01228-200
Actively Recruiting
30
IBTED - Tecnologia e Educação em Diabetes
São Paulo, Brazil, 04038-032
Actively Recruiting
31
Hospital das Clinicas FMUSP
São Paulo, Brazil, 05403-000
Actively Recruiting
32
Alberta Diabetes Institute
Edmonton, Canada, T6G 2E1
Not Yet Recruiting
33
BC Diabetes Office
Vancouver, Canada, V5Y 3W2
Actively Recruiting
34
Oulun yliopistollinen sairaala
Oulu, Finland, 90220
Not Yet Recruiting
35
Tampereen yliopistollinen sairaala
Tampere, Finland, 33520
Not Yet Recruiting
36
Turku University Hospital
Turku, Finland, 20520
Actively Recruiting
37
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, France, 69677
Not Yet Recruiting
38
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
Not Yet Recruiting
39
Hopital Claude Huriez - CHU de Lille
Lille, France, 59037
Not Yet Recruiting
40
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, France, 13385
Not Yet Recruiting
41
Pitie Salpetriere University Hospital
Paris, France, 75013
Not Yet Recruiting
42
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
43
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
Not Yet Recruiting
44
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, France, 75019
Not Yet Recruiting
45
CHU Rangueil
Toulouse, France, 31059
Not Yet Recruiting
46
Universitaetsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
47
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Germany, 01307
Not Yet Recruiting
48
Hannoversche Kinderheilanstalt
Hanover, Germany, 30173
Actively Recruiting
49
TUM Klinikum
München, Germany, 80939
Actively Recruiting
50
Yitzhak Shamir Medical Center
Beer Yaacov, Israel, 70300
Actively Recruiting
51
Soroka Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
52
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
53
Institute of Diabetes, Technology and Research - Clalit Health
Herzliya, Israel, 4600201
Actively Recruiting
54
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
55
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
56
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Actively Recruiting
57
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
58
Sheba Medical Center
Ramat Gan, Israel, 5262100
Actively Recruiting
59
Kaplan Medical Center
Rehovot, Israel, 7610001
Actively Recruiting
60
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
61
Ospedale Pediatrico Salesi
Ancona, Italy, 60123
Actively Recruiting
62
IRCCS - AOU di Bologna
Bologna, Italy, 40138
Actively Recruiting
63
Ospedale Microcitemico
Cagliari, Italy, 09121
Not Yet Recruiting
64
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Italy, 50139
Actively Recruiting
65
Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
66
University of Naples Federico II
Naples, Italy, 80100
Actively Recruiting
67
University of Naples Federico II
Naples, Italy, 80131
Actively Recruiting
68
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy, 28100
Actively Recruiting
69
Azienda Ospedale - Università Padova
Padova, Italy, 35128
Not Yet Recruiting
70
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Italy, 37126
Actively Recruiting
71
Abeno Medical Clinic
Abeno, Japan, 545-0052
Actively Recruiting
72
Saitama Medical University Hospital
Iruma, Japan, 350-0495
Actively Recruiting
73
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, Japan, 211-8533
Actively Recruiting
74
Yamanashi Prefectural Central Hospital
Kofu, Japan, 400-8506
Actively Recruiting
75
Seino Internal Medicine Clinic
Kōriyama, Japan, 963-8851
Actively Recruiting
76
Jinnouchi Hospital
Kumamoto, Japan, 862-0976
Actively Recruiting
77
Nagano Municipal Hospital
Nagano, Japan, 381-8551
Actively Recruiting
78
Nakakinen clinic
Naka, Japan, 311-0113
Actively Recruiting
79
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Actively Recruiting
80
Diabeter - Rotterdam
Rotterdam, Netherlands, 3011 TA
Not Yet Recruiting
81
Haukeland Universitetssjukehus
Bergen, Norway, 5021
Actively Recruiting
82
Akershus Universitetssykehus
Lørenskog, Norway, 1478
Actively Recruiting
83
Oslo Universitetssykehus Ullevål
Oslo, Norway, 0450
Actively Recruiting
84
Oslo Universitetssykehus Aker
Oslo, Norway, 0586
Actively Recruiting
85
Stavanger Universitetssykehus
Stavanger, Norway, 4011
Actively Recruiting
86
MTZ Clinical Research Powered by Pratia
Warsaw, Poland, 02-172
Not Yet Recruiting
87
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Actively Recruiting
88
2Ca Braga
Braga, Portugal, 4710-243
Actively Recruiting
89
Unidade Local de Saude de Matosinhos
Matosinhos Municipality, Portugal, 4464-513
Not Yet Recruiting
90
Centro Materno Infantil do Norte
Porto, Portugal, 4050
Not Yet Recruiting
91
ULSAM - Hospital de Santa Luzia
Viana do Castelo, Portugal, 4900-858
Actively Recruiting
92
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, Portugal, 4434-502
Not Yet Recruiting
93
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, Spain, 48903
Actively Recruiting
94
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
95
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
96
Skånes Universitetssjukhus Malmö
Malmö, Sweden, 21428
Actively Recruiting
97
Universitetssjukhuset Örebro
Örebro, Sweden, 701 85
Not Yet Recruiting
98
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
99
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Not Yet Recruiting
100
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
Actively Recruiting
101
Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
102
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
103
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
104
Royal London Hospital
London, United Kingdom, E1 1BB
Actively Recruiting
105
St. George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
106
The John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Not Yet Recruiting
107
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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