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NCT07222137RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
150 (estimated)
First submitted
27 Oct 2025
Start date
12 Jan 2026
Primary completion date
Jul 2031
Lead sponsor
Eli Lilly and Company
NCT number
NCT07222137
EU CT number
2025-521797-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 150
  • From 12 Jan 2026 to the primary completion date, Jul 2031
  • 109 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have any other type of diabetes
  • 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

Other

  • Have uncontrolled high blood pressure

Who the study is looking for

  • 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

Age in the registry: 1 year to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (109)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Women's and Children's Hospital
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AdelaideAustraliaRecruiting
Box Hill Hospital
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Box HillAustraliaRecruiting
Royal Brisbane and Women's Hospital
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BrisbaneAustraliaRecruiting
Centre for Children's Health Research
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BrisbaneAustraliaRecruiting
Royal Children's Hospital
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MelbourneAustraliaRecruiting
The Royal Melbourne Hospital
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ParkvilleAustraliaRecruiting
Perth Children's Hospital
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PerthAustraliaRecruiting
Sydney Children's Hospital
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RandwickAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
Antwerp University Hospital
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AntwerpenBelgiumRecruiting
Cliniques Universitaries Saint Luc
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Bruxelles-CapitaleBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumRecruiting
Freire Pesquisa Clinica
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Belo HorizonteBrazilRecruiting
Centro de Diabetes Curitiba
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CuritibaBrazilRecruiting
Hospital Universitario Walter Cantidio
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FortalezaBrazilRecruiting
Cendi - Endocrinologia e Diabetes
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GoiâniaBrazilRecruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
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MaríliaBrazilRecruiting
Universidade Federal Do Rio de Janeiro
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Rio de JaneiroBrazilRecruiting
Instituto de Pesquisa Clinica
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São PauloBrazilRecruiting
Hospital das Clinicas FMUSP
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São PauloBrazilRecruiting
CPCLIN
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São PauloBrazilRecruiting
IBTED - Tecnologia e Educação em Diabetes
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São PauloBrazilRecruiting
Alberta Children's Hospital
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CalgaryCanadaNot yet recruiting
Alberta Diabetes Institute
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EdmontonCanadaRecruiting
BC Diabetes Office
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VancouverCanadaRecruiting
KJF Klinik Josefinum gGmbH
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AugsburgGermanyRecruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
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DresdenGermanyRecruiting
Hannoversche Kinderheilanstalt
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HanoverGermanyRecruiting
TUM Klinikum
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MünchenGermanyRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Pohjois-Pohjanmaan hyvinvointialue
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OuluFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Varsinais-Suomen hyvinvointialue
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TurkuFinlandRecruiting
Hospices Civils de Lyon - Hopital Louis Pradel
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BronFranceNot yet recruiting
Centre Hospitalier Sud Francilien
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Corbeil Essonnes CedexFranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
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MarseilleFranceNot yet recruiting
Robert Debre University Hospital
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ParisFranceNot yet recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
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ParisFranceNot yet recruiting
Hopital Necker Enfants Malades
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ParisFranceNot yet recruiting
Pitié-Salpêtrière University Hospital
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ParisFranceNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceNot yet recruiting
Birmingham Children's Hospital
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BirminghamUnited KingdomRecruiting
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
University Hospital of Wales
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CardiffUnited KingdomRecruiting
Noah's Ark Children's Hospital for Wales
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CardiffUnited KingdomRecruiting
Queen Elizabeth University Hospital
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GlasgowUnited KingdomRecruiting
St. George's Hospital
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LondonUnited KingdomRecruiting
Royal London Hospital
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LondonUnited KingdomRecruiting
The John Radcliffe Hospital
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OxfordUnited KingdomRecruiting
Southampton General Hospital
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SouthamptonUnited KingdomRecruiting
Soroka Medical Center
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BeershebaIsraelRecruiting
Yitzhak Shamir Medical Center
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Beer YaacovIsraelRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Carmel Hospital
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HaifaIsraelRecruiting
Institute of Diabetes, Technology and Research - Clalit Health
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HerzliyaIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
Schneider Children's Medical Center
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Petah TikvaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Kaplan Medical Center
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RehovotIsraelRecruiting
Sourasky Medical Center
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Tel AvivIsraelRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
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AnconaItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
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CagliariItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Abeno Medical Clinic
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AbenoJapanRecruiting
Saitama Medical University Hospital
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IrumaJapanRecruiting
Nippon Medical School Musashi Kosugi Hospital
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KawasakiJapanRecruiting
Yamanashi Prefectural Central Hospital
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KofuJapanRecruiting
Seino Internal Medicine Clinic
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KōriyamaJapanRecruiting
Jinnouchi Hospital
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KumamotoJapanRecruiting
Nagano Municipal Hospital
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NaganoJapanRecruiting
Nakakinen clinic
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NakaJapanRecruiting
Niigata University Medical & Dental Hospital
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NiigataJapanRecruiting
Diabeter Nederland B.V.
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RotterdamNetherlandsRecruiting
Helse Bergen HF
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BergenNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Helse Stavanger HF
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StavangerNorwayRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalRecruiting
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalRecruiting
Unidade Local De Saude Do Alto Minho E.P.E.
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Viana do CasteloPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Skåne University Hospital
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MalmöSwedenRecruiting
Region Oerebro Laen
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OrebroSwedenRecruiting
University Medical Centre Ljubljana
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LjubljanaSloveniaNot yet recruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
University of Iowa
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Iowa CityUnited StatesRecruiting
Novak Center for Children's Health
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LouisvilleUnited StatesRecruiting
Children's Hospital of Philadelphia (CHOP)
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PhiladelphiaUnited StatesNot yet recruiting
Sansum Diabetes Research Institute
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Santa BarbaraUnited StatesNot yet recruiting
Tallahassee Memorial Healthcare
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TallahasseeUnited StatesRecruiting
Iowa Diabetes and Endocrinology Research Center
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West Des MoinesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.