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

May 20, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • 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

  • 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
        • Not yet recruiting
        • Royal Brisbane and Women's Hospital
        • Principal Investigator:
          • Donald McLeod
        • Contact:
          • Phone Number: +61736468111
      • Brisbane, Australia, 4101
        • Not yet 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
        • Not yet recruiting
        • UZ Brussel
        • Contact:
          • Phone Number: 0475956681
        • Principal Investigator:
          • Willem Staels
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Christophe De Block
        • Contact:
          • Phone Number: 0032 8214364
      • Leuven, Belgium, 3000
        • Not yet 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 Clínica
        • 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 Universitario Walter Cantidio
        • 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
      • 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
        • Not yet recruiting
        • Oulun yliopistollinen sairaala
        • Principal Investigator:
          • Riitta Veijola
      • Tampere, Finland, 33520
        • Not yet recruiting
        • Tampereen yliopistollinen sairaala
        • Contact:
          • Phone Number: 358503539956
        • Principal Investigator:
          • Sauli Palmu
      • Turku, Finland, 20520
        • Not yet 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 32 18
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • Universitaetsklinikum Augsburg
        • Contact:
          • Phone Number: 00498214009201
        • Principal Investigator:
          • Desiree Dunstheimer
      • 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
      • 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
      • 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
        • Not yet 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
        • Not yet 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
        • Not yet recruiting
        • Unidade Local de Saude de Matosinhos
        • Principal Investigator:
          • Rosa Maria Príncipe
      • Porto, Portugal, 4050
        • Not yet 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
  • 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 Ramon 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
        • Not yet recruiting
        • Universitetssjukhuset Örebro
        • Principal Investigator:
          • Frida Sundberg
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Not yet 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
        • Not yet 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
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Not yet 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
        • Not yet 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
        • Not yet 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

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
Intervention / Treatment
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

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

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

Eli Lilly and Company

Investigators

  • 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)

January 12, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Actual)

October 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27404
  • 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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