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

September 3, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5006
        • Recruiting
        • Women's and Children's Hospital
        • Principal Investigator:
          • Jennifer Couper
      • Box Hill, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Principal Investigator:
          • Ming Li Yee
      • Brisbane, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Principal Investigator:
          • Donald McLeod
        • Contact:
          • Phone Number: +61736468111
      • Brisbane, Australia, 4101
        • Recruiting
        • Centre for Children's Health Research
        • Principal Investigator:
          • Tony Huynh
      • Melbourne, Australia, 3052
        • Not yet recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Fergus Cameron
      • Parkville, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Principal Investigator:
          • John Wentworth
      • Perth, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
        • Principal Investigator:
          • Elizabeth Davis
      • Randwick, Australia, 2031
        • Recruiting
        • Sydney Children's Hospital
        • Principal Investigator:
          • Kristen Neville
      • Westmead, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
        • Principal Investigator:
          • Ann Maguire
        • Contact:
          • Phone Number: 02 9845 3171
  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Phone Number: 3227647052
        • Principal Investigator:
          • Philippe Lysy
      • Brussels, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Contact:
          • Phone Number: 0475956681
        • Principal Investigator:
          • Willem Staels
      • Edegem, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Christophe De Block
        • Contact:
          • Phone Number: 0032 8214364
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Chantal Mathieu
        • Contact:
          • Phone Number: +3216346994
      • Namur, Belgium, 5000
        • Not yet recruiting
        • CHU UCL Namur/Site Sainte Elisabeth
        • Contact:
          • Phone Number: +32-81-720505
        • Principal Investigator:
          • Dominique Beckers
  • Brazil
      • Belo Horizonte, Brazil, 30150-320
        • Recruiting
        • Freire Pesquisa Clinica
        • Principal Investigator:
          • Flávia Maia
      • Curitiba, Brazil, 80810-040
        • Recruiting
        • Centro de Diabetes Curitiba
        • Contact:
          • Phone Number: 554130231252
        • Principal Investigator:
          • André Vianna
      • Fortaleza, Brazil, 60430-270
        • Recruiting
        • Hospital Universitário Walter Cantídio
        • Principal Investigator:
          • Renan Montenegro
      • Goiânia, Brazil, 74230-035
        • Recruiting
        • Cendi - Endocrinologia e Diabetes
        • Contact:
          • Phone Number: 5562992240229
        • Principal Investigator:
          • Nelson Rassi
      • Marília, Brazil, 17504-072
        • Recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Principal Investigator:
          • José Sgarbi
        • Contact:
          • Phone Number: 55 14 21051477
      • Rio de Janeiro, Brazil, 21941-590
        • Recruiting
        • Universidade Federal do Rio de Janeiro
        • Principal Investigator:
          • Melanie Rodacki
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital das Clinicas FMUSP
        • Principal Investigator:
          • Maria Elizabeth Rossi da Silva
      • São Paulo, Brazil, 01223-001
        • Recruiting
        • Instituto de Pesquisa Clinica
        • Contact:
          • Phone Number: 551127370277
        • Principal Investigator:
          • Joao Salles
      • São Paulo, Brazil, 01228-200
        • Recruiting
        • CPCLIN
        • Principal Investigator:
          • Denise Franco
        • Contact:
          • Phone Number: 551126303777
      • São Paulo, Brazil, 04038-032
        • Recruiting
        • IBTED - Tecnologia e Educação em Diabetes
        • Contact:
          • Phone Number: 551197116-9844
        • Principal Investigator:
          • Monica Gabbay
  • Canada
      • Calgary, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Carol Huang
      • Edmonton, Canada, T6G 2E1
        • Not yet recruiting
        • Alberta Diabetes Institute
        • Principal Investigator:
          • Peter Senior
      • Vancouver, Canada, V5Y 3W2
        • Recruiting
        • BC Diabetes Office
        • Principal Investigator:
          • Thomas Elliott
        • Contact:
          • Phone Number: 604-683-3734 x 1001
  • Finland
      • Oulu, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala
        • Principal Investigator:
          • Riitta Veijola
      • Tampere, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala
        • Contact:
          • Phone Number: 358503539956
        • Principal Investigator:
          • Sauli Palmu
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
        • Principal Investigator:
          • Jorma Toppari
  • France
      • Bron, France, 69677
        • Not yet recruiting
        • Hospices Civils de Lyon - Hopital Louis Pradel
        • Principal Investigator:
          • Marc Nicolino
        • Contact:
          • Phone Number: 33472129525
      • Corbeil-Essonnes, France, 91106
        • Not yet recruiting
        • Centre Hospitalier Sud Francilien
        • Principal Investigator:
          • Alfred Penfornis
        • Contact:
          • Phone Number: 33161693086
      • Lille, France, 59037
        • Not yet recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Principal Investigator:
          • Anne VAMBERGUE
      • Marseille, France, 13385
        • Not yet recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
        • Principal Investigator:
          • Rachel Reynaud
        • Contact:
          • Phone Number: 33 491388384
      • Paris, France, 75013
        • Not yet recruiting
        • Pitie Salpetriere University Hospital
        • Principal Investigator:
          • Chloé AMOUYAL
      • Paris, France, 75015
        • Not yet recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Contact:
          • Phone Number: 01 44 49 48 01
        • Principal Investigator:
          • Alix BESANCON
      • Paris, France, 75019
        • Not yet recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
        • Principal Investigator:
          • Elise Bismuth
        • Contact:
          • Phone Number: 33140032000
      • Paris, France, 75014
        • Not yet recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin
        • Principal Investigator:
          • Roberto Mallone
      • Toulouse, France, 31059
        • Not yet recruiting
        • CHU Rangueil
        • Principal Investigator:
          • Pierre Gourdy
        • Contact:
          • Phone Number: 33 5 61 32 30 18
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • Universitaetsklinikum Augsburg
        • Contact:
          • Phone Number: 00498214009201
        • Principal Investigator:
          • Desiree Dunstheimer
      • Augsburg, Germany, 86154
        • Not yet recruiting
        • Klinik Josefinum
        • Contact:
          • Phone Number: 00498212412200
        • Principal Investigator:
          • Thomas Völkl
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
        • Contact:
          • Phone Number: 03514587510
        • Principal Investigator:
          • Gita Gemulla
      • Hanover, Germany, 30173
        • Recruiting
        • Hannoversche Kinderheilanstalt
        • Principal Investigator:
          • Olga Kordonouri
        • Contact:
          • Phone Number: 004951181153331
      • München, Germany, 80939
        • Recruiting
        • TUM Klinikum
        • Contact:
          • Phone Number: 0049 89 3187 2896
        • Principal Investigator:
          • Anette Ziegler
  • Israel
      • Beer Yaacov, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • Marianna Rachmiel
        • Contact:
          • Phone Number: 97289542166
      • Beersheba, Israel, 8410101
        • Recruiting
        • Soroka Medical Center
        • Contact:
          • Phone Number: 97286244150
        • Principal Investigator:
          • Alon Haim
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • Ram Weiss
        • Contact:
          • Phone Number: 97247774411
      • Haifa, Israel, 3436212
        • Not yet recruiting
        • Carmel Hospital
        • Principal Investigator:
          • Inbal Halabi
      • Herzliya, Israel, 4600201
        • Recruiting
        • Institute of Diabetes, Technology and Research - Clalit Health
        • Principal Investigator:
          • Eytan Roitman
        • Contact:
          • Phone Number: 972-9-9613210
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Principal Investigator:
          • Genya Aharon Hananel
        • Contact:
          • Phone Number: 97226776927
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Victor Vishlitzky
        • Contact:
          • Phone Number: 972-97472559
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Moshe Phillip
        • Contact:
          • Phone Number: 97239253282
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Principal Investigator:
          • Idit Dotan
        • Contact:
          • Phone Number: +97239377183
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Amir Tirosh
        • Contact:
          • Phone Number: +972035302021
      • Ramat Gan, Israel, 5262100
        • Not yet recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Noah Gruber
        • Contact:
          • Phone Number: 035308469
      • Rehovot, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
        • Contact:
          • Phone Number: +9728-9441361
        • Principal Investigator:
          • Alena Kirzhner
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Phone Number: 97236974863
        • Principal Investigator:
          • Yael Lebenthal
  • Italy
      • Ancona, Italy, 60123
        • Recruiting
        • Ospedale Pediatrico Salesi
        • Contact:
          • Phone Number: 390715962011
        • Principal Investigator:
          • Valentino Cherubini
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS - AOU di Bologna
        • Contact:
          • Phone Number: 0512143009
        • Principal Investigator:
          • Guido Di Dalmazi
      • Cagliari, Italy, 09121
        • Not yet recruiting
        • Ospedale Microcitemico
        • Contact:
          • Phone Number: +39 070 52965605
        • Principal Investigator:
          • Carlo Ripoli
      • Florence, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Universitaria Meyer IRCCS
        • Contact:
          • Phone Number: 3384034476
        • Principal Investigator:
          • Lorenzo Lenzi
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Contact:
          • Phone Number: 0226432818
        • Principal Investigator:
          • Emanuele Bosi
      • Naples, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Principal Investigator:
          • Enza Mozzillo
      • Naples, Italy, 80100
        • Recruiting
        • University of Naples Federico II
        • Contact:
          • Phone Number: +390817462311
        • Principal Investigator:
          • Lutgarda Bozzetto
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità
        • Principal Investigator:
          • Ivana Rabbone
        • Contact:
          • Phone Number: 3903213733350
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedale - Università Padova
        • Contact:
          • Phone Number: 3357940960
        • Principal Investigator:
          • Carlo Moretti
      • Verona, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
        • Contact:
          • Phone Number: 0458127662
        • Principal Investigator:
          • Claudio Maffeis
  • Japan
      • Abeno, Japan, 545-0052
        • Recruiting
        • Abeno Medical Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoyuki Kawamura
      • Iruma, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoichi Oikawa
      • Kawasaki, Japan, 211-8533
        • Recruiting
        • Nippon Medical School Musashi Kosugi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hanako Tajima
      • Kofu, Japan, 400-8506
        • Recruiting
        • Yamanashi Prefectural Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaharu Inoue
      • Kumamoto, Japan, 862-0976
        • Recruiting
        • Jinnouchi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hideaki Jinnouchi
      • Kōriyama, Japan, 963-8851
        • Recruiting
        • Seino Internal Medicine Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Seino
      • Nagano, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • ASAMI SANO
      • Naka, Japan, 311-0113
        • Recruiting
        • Nakakinen clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takeshi Osonoi
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yohei Ogawa
  • Netherlands
      • Rotterdam, Netherlands, 3011 TA
        • Recruiting
        • Diabeter - Rotterdam
        • Contact:
          • Phone Number: +31-88-280-7277
        • Principal Investigator:
          • Hendrik Aanstoot
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • Haukeland universitetssjukehus
        • Principal Investigator:
          • Henrik Irgens
      • Lørenskog, Norway, 1478
        • Recruiting
        • Akershus universitetssykehus
        • Principal Investigator:
          • Christopher Inchley
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Universitetssykehus Ullevål
        • Contact:
          • Phone Number: +4797522277
        • Principal Investigator:
          • Lars Krogvold
      • Oslo, Norway, 0586
        • Recruiting
        • Oslo Universitetssykehus Aker
        • Principal Investigator:
          • Kari Anne Sveen
      • Stavanger, Norway, 4011
        • Recruiting
        • Stavanger Universitetssykehus
        • Principal Investigator:
          • Sondre Meling
  • Poland
      • Warsaw, Poland, 02-172
        • Not yet recruiting
        • MTZ Clinical Research Powered By Pratia
        • Principal Investigator:
          • Agnieszka Szypowska
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
        • Contact:
          • Phone Number: +48502056191
        • Principal Investigator:
          • EDYTA JABLONSKA-WYPUSTEK
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • 2Ca Braga
        • Principal Investigator:
          • Ana Sofia Martins
      • Matosinhos Municipality, Portugal, 4464-513
        • Recruiting
        • Unidade Local de Saúde de Matosinhos
        • Principal Investigator:
          • Rosa Maria Príncipe
      • Porto, Portugal, 4050
        • Recruiting
        • Centro Materno Infantil do Norte
        • Contact:
          • Phone Number: +351914125573
        • Principal Investigator:
          • Teresa Maria da Silva Borges Ferreira
      • Viana do Castelo, Portugal, 4900-858
        • Recruiting
        • ULSAM - Hospital de Santa Luzia
        • Contact:
          • Phone Number: 961790293
        • Principal Investigator:
          • Maria Cristina Roque
      • Vila Nova de Gaia, Portugal, 4434-502
        • Not yet recruiting
        • Unidade Local De Saude De Gaia/Espinho E.P.E.
        • Principal Investigator:
          • Marta Ferreira
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Not yet recruiting
        • University Medical Centre Ljubljana
        • Principal Investigator:
          • Tadej Battelino
  • Spain
      • Barakaldo, Spain, 48903
        • Recruiting
        • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
        • Contact:
          • Phone Number: 946006000
        • Principal Investigator:
          • NANCY PORTILLO NAJERA
      • Esplugues de Llobregat, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu
        • Principal Investigator:
          • Roque Cardona-Hernandez
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Phone Number: +34621360800
        • Principal Investigator:
          • Lía Nattero Chávez
  • Sweden
      • Malmö, Sweden, 21428
        • Recruiting
        • Skånes Universitetssjukhus Malmö
        • Principal Investigator:
          • Helena Elding Larsson
      • Örebro, Sweden, 701 85
        • Recruiting
        • Universitetssjukhuset Orebro
        • Principal Investigator:
          • Frida Sundberg
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Children's Hospital
        • Principal Investigator:
          • Renuka Dias
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • parth narendran
      • Cambridge, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Phone Number: +44 1223 336994
        • Principal Investigator:
          • Mark Evans
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Noah's Ark Children's Hospital for Wales
        • Principal Investigator:
          • Ambika Shetty
        • Contact:
          • Phone Number: 02920742274
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
        • Principal Investigator:
          • Maitrayee Choudhury
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth University Hospital
        • Principal Investigator:
          • Rajeeb Rashid
      • London, United Kingdom, E1 1BB
        • Recruiting
        • Royal London Hospital
        • Principal Investigator:
          • Ruben Willemsen
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St. George's Hospital
        • Contact:
          • Phone Number: 07885278793
        • Principal Investigator:
          • Mimi Chen
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • The John Radcliffe Hospital
        • Principal Investigator:
          • Rachel Besser
        • Contact:
          • Phone Number: 01865231729
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Contact:
          • Phone Number: 02381208518
        • Principal Investigator:
          • Nicola Trevelyan
  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Not yet recruiting
        • Sansum Diabetes Research Institute
        • Contact:
          • Phone Number: 805-682-7638
        • Principal Investigator:
          • Kristin Castorino
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Memorial HealthCare
        • Contact:
          • Phone Number: 850-431-5404
        • Principal Investigator:
          • Larry Deeb
      • Tampa, Florida, United States, 33612
        • Suspended
        • University of South Florida
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Phone Number: 319-356-4511
        • Principal Investigator:
          • Michael Tansey
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
          • Phone Number: 515-329-6800
        • Principal Investigator:
          • Anuj Bhargava
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Not yet recruiting
        • Novak Center for Children's Health
        • Contact:
          • Phone Number: 502-629-5820
        • Principal Investigator:
          • Kupper Wintergerst
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia (CHOP)
        • Contact:
          • Phone Number: 267-426-7037
        • Principal Investigator:
          • Steven Willi
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Aaron Misakian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Baricitinib
Participants will receive baricitinib orally
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes
Time Frame: Baseline up to approximately 5 years
Baseline up to approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Height
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Matsuda Index
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Glucose AUC
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile
Time Frame: Baseline, Week 52
Baseline, Week 52
Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive)
Time Frame: Baseline, Week 52
Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time Frame: Predose through Week 24
Predose through Week 24
PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib
Time Frame: Predose through Week 24
Predose through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27404
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521797-34-00 (Ctis)
  • I4V-MC-JAJJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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