A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

May 20, 2026 updated by: Eli Lilly and Company

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Australia
      • Adelaide, Australia, 5006
        • Recruiting
        • Women's and Children's Hospital
        • Principal Investigator:
          • Jennifer Couper
      • Brisbane, Australia, 4101
        • Not yet recruiting
        • Centre for Children's Health Research
        • Principal Investigator:
          • Tony Huynh
      • Heidelberg West, Australia, 3081
        • Recruiting
        • Austin Health - Repatriation Hospital
        • Contact:
          • Phone Number: 0394962160
        • Principal Investigator:
          • Elif Ekinci
      • Ipswich, Australia, 4305
        • Recruiting
        • Ipswich Hospital
        • Principal Investigator:
          • Thomas Dover
        • Contact:
          • Phone Number: 0402112100
      • Melbourne, Australia, 3052
        • Not yet recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Fergus Cameron
      • Oaklands Park, Australia, 5046
        • Recruiting
        • Southern Adelaide Diabetes & Endocrine Services
        • Principal Investigator:
          • Natalie Giles
      • 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
        • Not yet 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
      • Brussels, Belgium, 1070
        • Not yet recruiting
        • Université Libre de Bruxelles - Hôpital Erasme
        • Principal Investigator:
          • Miriam Cnop
        • Contact:
          • Phone Number: 3225556305
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Christophe De Block
        • Contact:
          • Phone Number: 0032 8214364
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • UZ Gent
        • Principal Investigator:
          • Imke Matthys
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Chantal Mathieu
        • Contact:
          • Phone Number: +3216346994
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
        • Contact:
          • Phone Number: 00 32 4 323 34 13
        • Principal Investigator:
          • jean-christophe philips
      • Namur, Belgium, 5000
        • Not yet recruiting
        • CHU UCL Namur/Site Sainte Elisabeth
        • Contact:
          • Phone Number: +32-81-720505
        • Principal Investigator:
          • Dominique Beckers
      • Yvoir, Belgium, 5530
        • Not yet recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
        • Contact:
          • Phone Number: +32-81-720505
        • Principal Investigator:
          • Dominique Beckers
  • Brazil
      • Campo Grande, Brazil, 79080-190
        • Not yet recruiting
        • Hospital Universitario Maria Aparecida Pedrossian
        • Principal Investigator:
          • Delcio da Silva Junior
      • Curitiba, Brazil, 80045170
        • Not yet recruiting
        • Quanta Diagnóstico e Terapia
        • Contact:
          • Phone Number: 5541999736442
        • Principal Investigator:
          • Rosangela Rea
      • Curitiba, Brazil, 80810-040
        • Not yet recruiting
        • Centro de Diabetes Curitiba
        • Contact:
          • Phone Number: 554130231252
        • Principal Investigator:
          • André Vianna
      • Fortaleza, Brazil, 60175-047
        • Not yet recruiting
        • Centro De Diabetes Metabolismo E Endocrinologia
        • Contact:
          • Phone Number: 5585996190895
        • Principal Investigator:
          • ADRIANA FORTI
      • Goiânia, Brazil, 74230-035
        • Not yet recruiting
        • Cendi - Endocrinologia e Diabetes
        • Contact:
          • Phone Number: 5562992240229
        • Principal Investigator:
          • Nelson Rassi
      • Marília, Brazil, 17504-072
        • Not yet recruiting
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Principal Investigator:
          • José Sgarbi
        • Contact:
          • Phone Number: 55 14 21051477
      • Porto Alegre, Brazil, 91350-250
        • Not yet recruiting
        • Instituto da Crianca com Diabetes
        • Contact:
          • Phone Number: 55133372215
        • Principal Investigator:
          • Balduino Tschiedel
      • Ribeirão Preto, Brazil, 14051-140
        • Not yet recruiting
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
        • Principal Investigator:
          • Raphael Liberatore
      • Rio de Janeiro, Brazil, 21941-590
        • Not yet 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, 04038-032
        • Not yet recruiting
        • IBTED - Tecnologia e Educação em Diabetes
        • Contact:
          • Phone Number: 551197116-9844
        • Principal Investigator:
          • Monica Gabbay
      • São Paulo, Brazil, 01228-200
        • Not yet recruiting
        • CPCLIN
        • Principal Investigator:
          • Denise Franco
        • Contact:
          • Phone Number: 551126303777
      • São Paulo, Brazil, 01223-001
        • Not yet recruiting
        • Instituto de Pesquisa Clinica
        • Contact:
          • Phone Number: 551127370277
        • Principal Investigator:
          • Joao Salles
      • São Paulo, Brazil, 04077-020
        • Not yet recruiting
        • Clínica Hepatogastro JK
        • Contact:
          • Phone Number: 5511963934548
        • Principal Investigator:
          • DEBORA NAZATO
      • Vitória, Brazil, 29055450
        • Not yet recruiting
        • CEDOES
        • Contact:
          • Phone Number: 55 27 99933-3330
        • Principal Investigator:
          • Queulla Santos
  • Canada
      • Calgary, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Carol Huang
      • Chicoutimi, Canada, G7H 5H6
        • Not yet recruiting
        • CIUSSS- saguenay-Lac-Saint-Jean
        • Principal Investigator:
          • Raphaëlle Chrétien
      • Edmonton, Canada, T6G 2E1
        • Not yet recruiting
        • Alberta Diabetes Institute
        • Principal Investigator:
          • Peter Senior
      • London, Canada, N6A 4V2
        • Not yet recruiting
        • St. Joseph's Health Care
        • Principal Investigator:
          • Tamara Spaic
        • Contact:
          • Phone Number: 519-646-6370
      • Ottawa, Canada, K2J 0V2
        • Not yet recruiting
        • Centricity Research Ottawa LMC Endocrinology
        • Contact:
          • Phone Number: 613-505-9704
        • Principal Investigator:
          • Nadia Malakieh
      • Québec, Canada, G1V 4G2
        • Not yet recruiting
        • CHUL et Centre mère-enfant Soleil
        • Principal Investigator:
          • Martin D'Amours
      • Vancouver, Canada, V5Y 3W2
        • Recruiting
        • BC Diabetes Office
        • Principal Investigator:
          • Thomas Elliott
        • Contact:
          • Phone Number: 604-683-3734 x 1001
  • Czechia
      • Jihlava, Czechia, 58633
        • Recruiting
        • Nemocnice Jihlava
        • Contact:
          • Phone Number: 420567157736
        • Principal Investigator:
          • Pavel Vlachy
      • Ostrava, Czechia, 70852
        • Recruiting
        • Fakultni Nemocnice Ostrava
        • Contact:
          • Phone Number: 420 597 373 522
        • Principal Investigator:
          • Jiri Strnadel
      • Prague, Czechia, 14900
        • Recruiting
        • Milan Kvapil s.r.o., Diabetologicka ambulance
        • Contact:
          • Phone Number: 420272917011
        • Principal Investigator:
          • Frantisek Loos
  • Finland
      • Helsinki, Finland, 00029
        • Not yet recruiting
        • New Children's Hospital
        • Contact:
          • Phone Number: 0445573392
        • Principal Investigator:
          • Tero Varimo
      • 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
        • Recruiting
        • Turku University Hospital
        • Principal Investigator:
          • Jorma Toppari
  • France
      • Bron, France, 69677
        • Not yet recruiting
        • Hospices Civils de Lyon - Hôpital 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
      • Grenoble, France, 38700
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Grenoble
        • Principal Investigator:
          • Sandrine LABLANCHE
      • 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
      • Toulouse, France, 31059
        • Not yet recruiting
        • CHU Rangueil
        • Principal Investigator:
          • Pierre Gourdy
        • Contact:
          • Phone Number: 33 5 61 32 32 18
  • Germany
      • Hanover, Germany, 30173
        • Not yet recruiting
        • Hannoversche Kinderheilanstalt
        • Contact:
          • Phone Number: 4951181153331
        • Principal Investigator:
          • Felix Reschke
      • Hof, Germany, 95030
        • Recruiting
        • Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
        • Principal Investigator:
          • Mesut Durmaz
        • Contact:
          • Phone Number: 0049928114037037
      • Karlsburg, Germany, 17495
        • Not yet recruiting
        • Klinikum Karlsburg
        • Contact:
          • Phone Number: 004938355701397
        • Principal Investigator:
          • Petra Augstein
      • Ludwigshafen am Rhein, Germany, 67059
        • Recruiting
        • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
        • Principal Investigator:
          • Hans-Peter Kempe
        • Contact:
          • Phone Number: 0049621 62900552
      • München, Germany, 80939
        • Recruiting
        • TUM Klinikum
        • Contact:
          • Phone Number: 0049 89 3187 2896
        • Principal Investigator:
          • Anette Ziegler
      • Oldenburg, Germany, 23758
        • Recruiting
        • RED-Institut GmbH
        • Principal Investigator:
          • Thomas Schaum
        • Contact:
          • Phone Number: 0049436150630128
      • Sankt Augustin, Germany, 53757
        • Recruiting
        • Asklepios Klinik Sankt Augustin
        • Principal Investigator:
          • Gerd Horneff
        • Contact:
          • Phone Number: 00492241249201
      • Ulm, Germany, 89075
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Phone Number: 004973150057401
        • Principal Investigator:
          • Christian Denzer
  • Israel
      • Beer Yaacov, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • Marianna Rachmiel
        • Contact:
          • Phone Number: 97289542166
      • Beersheba, Israel, 8410101
        • Not yet 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, 3515209
        • Recruiting
        • Linn Medical Center
        • Contact:
          • Phone Number: 97248568685
        • Principal Investigator:
          • Baruch Itzhak
      • Herzliya, Israel, 4600201
        • Not yet 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
        • Not yet 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
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Phone Number: 97236974863
        • Principal Investigator:
          • Yael Lebenthal
  • Italy
      • Ancona, Italy, 60123
        • Not yet recruiting
        • Ospedale Pediatrico Salesi
        • Contact:
          • Phone Number: 390715962011
        • Principal Investigator:
          • Valentino Cherubini
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • Ilaria Dicembrini
      • Florence, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Universitaria Meyer IRCCS
        • Principal Investigator:
          • barbara piccini
      • Messina, Italy, 98125
        • Recruiting
        • Azienda Ospedaliera Universitaria Di Messina G. Martino
        • Contact:
          • Phone Number: +390902213023
        • Principal Investigator:
          • Fortunato Lombardo
      • 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
      • 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
  • Netherlands
      • Rotterdam, Netherlands, 3011 TA
        • Not yet recruiting
        • Diabeter - Rotterdam
        • Contact:
          • Phone Number: +31-88-280-7277
        • Principal Investigator:
          • Hendrik Aanstoot
  • Norway
      • Haugesund, Norway, 5528
        • Recruiting
        • Helse Fonna - Haugesund Sjukehus
        • Contact:
          • Phone Number: +47-92051592
        • Principal Investigator:
          • Heiko Bratke
      • Lørenskog, Norway, 1478
        • Recruiting
        • Akershus Universitetssykehus
        • Principal Investigator:
          • Christopher Inchley
      • Oslo, Norway, 0450
        • Not yet recruiting
        • Oslo Universitetssykehus Ullevål
        • Contact:
          • Phone Number: +4797522277
        • Principal Investigator:
          • Lars Krogvold
      • Oslo, Norway, 0316
        • Recruiting
        • Oslo Universitetssykehus Aker
        • Principal Investigator:
          • Kari Anne Sveen
      • Stavanger, Norway, 4011
        • Recruiting
        • Stavanger Universitetssykehus
        • Principal Investigator:
          • Sondre Meling
      • Trondheim, Norway, 7030
        • Recruiting
        • St. Olavs Hospital
        • Principal Investigator:
          • Torstein Rø
  • Poland
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Principal Investigator:
          • Anna Woloszyn-Durkiewicz
      • Lodz, Poland, 92-213
        • Not yet recruiting
        • UMED Clinical Trials
        • Principal Investigator:
          • Agnieszka Szadkowska
        • Contact:
          • Phone Number: 48 607145644
      • Warsaw, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by Pratia
        • Principal Investigator:
          • Agnieszka Szypowska
      • Wroclaw, Poland, 50-368
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
        • Principal Investigator:
          • Agnieszka Zubkiewicz-Kucharska
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • 2Ca Braga
        • Principal Investigator:
          • Ana Sofia Martins
      • 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
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Phone Number: +34932279846
        • Principal Investigator:
          • Antonio-Jesus Blanco-Carrasco
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
          • Phone Number: +34935565661
        • Principal Investigator:
          • Didac Mauricio
      • Esplugues de Llobregat, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Principal Investigator:
          • Roque Cardona-Hernandez
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Phone Number: +34621360800
        • Principal Investigator:
          • Lía Nattero Chávez
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Phone Number: 34639659866
        • Principal Investigator:
          • Luis Vazquez Salvi
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Phone Number: +34 955013767
        • Principal Investigator:
          • Ana Gómez Gila
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Virginia Bellido
        • Contact:
          • Phone Number: 955012000
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
        • Principal Investigator:
          • María Francisca Moreno Macián
        • Contact:
          • Phone Number: 696685777
  • Sweden
      • Lund, Sweden, 222 22
        • Not yet recruiting
        • ProbarE i Lund AB
        • Principal Investigator:
          • Anders Luts
        • Contact:
          • Phone Number: 46732300450
      • Stockholm, Sweden, 11437
        • Not yet recruiting
        • ProbarE i Stockholm AB
        • Principal Investigator:
          • Peter Bosson
        • Contact:
          • Phone Number: 0732300450
      • Uddevalla, Sweden, 451 53
        • Not yet recruiting
        • Uddevalla Sjukhus
        • Principal Investigator:
          • Marcus Lind
      • Örebro, Sweden, 701 85
        • Not yet recruiting
        • Universitetssjukhuset Örebro
        • Principal Investigator:
          • Frida Sundberg
      • Östersund, Sweden, 831 31
        • Not yet recruiting
        • Östersunds Sjukhus
        • Principal Investigator:
          • David Nöjdh
  • Ukraine
      • Kiev, Ukraine, 04114
        • Recruiting
        • Institute of Endocrinology and Metabolism named after Komissarenko
        • Principal Investigator:
          • Olesia Zinych
      • Kyiv, Ukraine, 01024
        • Recruiting
        • Kyiv City Endocrinological Center
        • Principal Investigator:
          • Yuliia Komisarenko
      • Uzhhorod, Ukraine, 88000
        • Recruiting
        • Zakarpattia Endoclinic
        • Contact:
          • Phone Number: +38 050 5958603
        • Principal Investigator:
          • Oksana Khyzhnyak
      • Vinnytsia, Ukraine, 21010
        • Recruiting
        • Vinnytsia Regional Clinical Endocrinology Dispensary
        • Contact:
          • Phone Number: +380432531735
        • Principal Investigator:
          • Maryna Vlasenko
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Principal Investigator:
          • Sam Philip
      • Birmingham, United Kingdom, B4 6NH
        • Not yet recruiting
        • Birmingham Children's Hospital
        • Principal Investigator:
          • Renuka Dias
      • Birmingham, United Kingdom, B15 2TH
        • Not yet recruiting
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • parth narendran
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital
        • Principal Investigator:
          • Georgina Russell
        • Contact:
          • Phone Number: 0117 4148125
      • Cambridge, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Principal Investigator:
          • Loredana Marcovecchio
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
        • Principal Investigator:
          • Maitrayee Choudhury
      • Oxford, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Churchill Hospital
        • Contact:
          • Phone Number: 01865857226
        • Principal Investigator:
          • Katharine Owen
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Contact:
          • Phone Number: 02381208518
        • Principal Investigator:
          • Nicola Trevelyan
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Barbara Davis Center for Childhood Diabetes
        • Contact:
          • Phone Number: 303-724-3861
        • Principal Investigator:
          • Andrea Steck
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Not yet recruiting
        • Tallahassee Memorial HealthCare
        • Contact:
          • Phone Number: 850-431-5404
        • Principal Investigator:
          • Larry Deeb
    • 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
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Not yet recruiting
        • Driscoll Children's Hospital
        • Principal Investigator:
          • Ana Paez
        • Contact:
          • Phone Number: 361-739-7250
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • University of Virginia
        • Contact:
          • Phone Number: 434-924-5956
        • Principal Investigator:
          • Christine Burt Solorzano

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 new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
  • Have at least one diabetes-related autoantibody found at screening

  • Show signs of remaining beta-cell function

    • stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
  • Weigh at least 8 kilograms (kg) (18 pounds) at screening

Exclusion Criteria:

  • Have any other type of diabetes including gestational
  • 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 medical condition or 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
Change from Baseline in C-peptide Area Under the Curve (AUC)
Time Frame: Baseline, Week 52
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Number of Manual Insulin Boluses
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Fasting C-Peptide
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Height
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Mean Total Daily Insulin Dose
Time Frame: Baseline, Week 52
Measured during the two weeks prior to the assessment
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
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Time Frame: Predose through Week 16
Predose through Week 16
Rate of Clinically Significant Hypoglycemic Events
Time Frame: Baseline through Week 52
Baseline through Week 52

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)

February 5, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27405
  • 2025-522170-36-00 (Ctis)
  • I4V-MC-JAJK (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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