Actively Recruiting

Phase 3
Age: 1Year - 35Years
All Genders
NCT07222137

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Led by Eli Lilly and Company · Updated on 2026-05-14

150

Participants Needed

106

Research Sites

285 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Who Can Participate

Age: 1Year - 35Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 106 locations

1

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States, 32308

Not Yet Recruiting

2

University of South Florida

Tampa, Florida, United States, 33612

Not Yet Recruiting

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

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet Recruiting

83

Oslo Universitetssykehus Ullevål

Oslo, Norway, 0450

Not Yet Recruiting

84

Oslo Universitetssykehus Aker

Oslo, Norway, 0586

Actively Recruiting

85

Stavanger Universitetssykehus

Stavanger, Norway, 4011

Actively Recruiting

86

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Poland, 04-501

Actively Recruiting

87

2Ca Braga

Braga, Portugal, 4710-243

Actively Recruiting

88

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, Portugal, 4464-513

Not Yet Recruiting

89

Centro Materno Infantil do Norte

Porto, Portugal, 4050

Not Yet Recruiting

90

ULSAM - Hospital de Santa Luzia

Viana do Castelo, Portugal, 4900-858

Actively Recruiting

91

Unidade Local De Saude De Gaia/Espinho E.P.E.

Vila Nova de Gaia, Portugal, 4434-502

Not Yet Recruiting

92

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Spain, 48903

Actively Recruiting

93

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain, 08950

Actively Recruiting

94

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

95

Skånes Universitetssjukhus Malmö

Malmö, Sweden, 21428

Actively Recruiting

96

Universitetssjukhuset Örebro

Örebro, Sweden, 701 85

Not Yet Recruiting

97

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

98

Birmingham Children's Hospital

Birmingham, United Kingdom, B4 6NH

Not Yet Recruiting

99

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 2QQ

Actively Recruiting

100

Noah's Ark Children's Hospital for Wales

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

101

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Not Yet Recruiting

102

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Not Yet Recruiting

103

Royal London Hospital

London, United Kingdom, E1 1BB

Actively Recruiting

104

St. George's Hospital

London, United Kingdom, SW17 0QT

Not Yet Recruiting

105

The John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Not Yet Recruiting

106

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

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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A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults | DecenTrialz