← Back to searchRecruitingRecruiting
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
NCT07222137 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 150 participants
Allocation: randomized
Masking: double
Age groups: child, adult
Timeline
Starts: 2026-01-12
Estimated completion: 2031-07
Last updated: 2026-04-17
Interventions
Drug: BaricitinibDrug: Placebo
Primary outcomes
- • Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes (Baseline up to approximately 5 years)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (107)
Tallahassee Memorial HealthCareNot Yet Recruiting
Tallahassee, Florida, United States
University of South FloridaNot Yet Recruiting
Tampa, Florida, United States
University of IowaNot Yet Recruiting
Iowa City, Iowa, United States
Iowa Diabetes and Endocrinology Research CenterRecruiting
West Des Moines, Iowa, United States
Novak Center for Children's HealthNot Yet Recruiting
Louisville, Kentucky, United States
Children's Hospital of Philadelphia (CHOP)Not Yet Recruiting
Philadelphia, Pennsylvania, United States
University of VirginiaNot Yet Recruiting
Charlottesville, Virginia, United States
Women's and Children's HospitalRecruiting
Adelaide, Australia
Box Hill HospitalRecruiting
Box Hill, Australia
Royal Brisbane and Women's HospitalNot Yet Recruiting
Brisbane, Australia
Centre for Children's Health ResearchNot Yet Recruiting
Brisbane, Australia
Royal Children's HospitalNot Yet Recruiting
Melbourne, Australia
The Royal Melbourne HospitalRecruiting
Parkville, Australia
Perth Children's HospitalNot Yet Recruiting
Perth, Australia
Sydney Children's HospitalRecruiting
Randwick, Australia
The Children's Hospital at WestmeadRecruiting
Westmead, Australia
UZ BrusselNot Yet Recruiting
Brussels, Belgium
Cliniques universitaires Saint-LucNot Yet Recruiting
Brussels, Belgium
Antwerp University HospitalNot Yet Recruiting
Edegem, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
CHU UCL Namur/Site Sainte ElisabethNot Yet Recruiting
Namur, Belgium
Freire Pesquisa ClínicaRecruiting
Belo Horizonte, Brazil
Centro de Diabetes CuritibaRecruiting
Curitiba, Brazil
Hospital Universitario Walter CantidioRecruiting
Fortaleza, Brazil
Cendi - Endocrinologia e DiabetesRecruiting
Goiânia, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMRecruiting
Marília, Brazil
Universidade Federal do Rio de JaneiroRecruiting
Rio de Janeiro, Brazil
Instituto de Pesquisa ClinicaRecruiting
São Paulo, Brazil
CPCLINRecruiting
São Paulo, Brazil
IBTED - Tecnologia e Educação em DiabetesNot Yet Recruiting
São Paulo, Brazil
Hospital das Clinicas FMUSPRecruiting
São Paulo, Brazil
Alberta Diabetes InstituteNot Yet Recruiting
Edmonton, Canada
BC Diabetes OfficeNot Yet Recruiting
Vancouver, Canada
Oulun yliopistollinen sairaalaNot Yet Recruiting
Oulu, Finland
Tampereen yliopistollinen sairaalaNot Yet Recruiting
Tampere, Finland
Turku University HospitalNot Yet Recruiting
Turku, Finland
Hospices Civils de Lyon - Hopital Louis PradelNot Yet Recruiting
Bron, France
Centre Hospitalier Sud FrancilienNot Yet Recruiting
Corbeil-Essonnes, France
Hopital Claude Huriez - CHU de LilleNot Yet Recruiting
Lille, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneNot Yet Recruiting
Marseille, France
Pitie Salpetriere University HospitalNot Yet Recruiting
Paris, France
Hopitaux Universitaires Paris Centre-Hopital CochinNot Yet Recruiting
Paris, France
Hôpital Universitaire Necker Enfants MaladesNot Yet Recruiting
Paris, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -TNot Yet Recruiting
Paris, France
CHU RangueilNot Yet Recruiting
Toulouse, France
Universitaetsklinikum AugsburgNot Yet Recruiting
Augsburg, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet DresdenNot Yet Recruiting
Dresden, Germany
Hannoversche KinderheilanstaltRecruiting
Hanover, Germany
TUM KlinikumRecruiting
München, Germany
Yitzhak Shamir Medical CenterRecruiting
Beer Yaacov, Israel
Soroka Medical CenterNot Yet Recruiting
Beersheba, Israel
Rambam Health Care CampusRecruiting
Haifa, Israel
Institute of Diabetes, Technology and Research - Clalit HealthNot Yet Recruiting
Herzliya, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Schneider Children's Medical CenterNot Yet Recruiting
Petah Tikva, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Kaplan Medical CenterRecruiting
Rehovot, Israel
Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Ospedale Pediatrico SalesiRecruiting
Ancona, Italy
IRCCS - AOU di BolognaRecruiting
Bologna, Italy
Ospedale MicrocitemicoNot Yet Recruiting
Cagliari, Italy
Azienda Ospedaliera Universitaria Meyer IRCCSRecruiting
Florence, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
University of Naples Federico IIRecruiting
Naples, Italy
University of Naples Federico IIRecruiting
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della CaritàRecruiting
Novara, Italy
Azienda Ospedale - Università PadovaNot Yet Recruiting
Padova, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoRecruiting
Verona, Italy
Abeno Medical ClinicRecruiting
Abeno, Japan
Saitama Medical University HospitalNot Yet Recruiting
Iruma, Japan
Nippon Medical School Musashi Kosugi HospitalRecruiting
Kawasaki, Japan
Yamanashi Prefectural Central HospitalRecruiting
Kofu, Japan
Seino Internal Medicine ClinicRecruiting
Kōriyama, Japan
Jinnouchi HospitalRecruiting
Kumamoto, Japan
Nagano Municipal HospitalRecruiting
Nagano, Japan
Soleil Chikusa ClinicNot Yet Recruiting
Nagoya, Japan
Nakakinen clinicRecruiting
Naka, Japan
Niigata University Medical & Dental HospitalRecruiting
Niigata, Japan
Diabeter - RotterdamNot Yet Recruiting
Rotterdam, Netherlands
Haukeland UniversitetssjukehusRecruiting
Bergen, Norway
Akershus UniversitetssykehusNot Yet Recruiting
Lørenskog, Norway
Oslo Universitetssykehus UllevålNot Yet Recruiting
Oslo, Norway
Oslo Universitetssykehus AkerNot Yet Recruiting
Oslo, Norway
Stavanger UniversitetssykehusRecruiting
Stavanger, Norway
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśRecruiting
Warsaw, Poland
2Ca BragaRecruiting
Braga, Portugal
Unidade Local de Saude de MatosinhosNot Yet Recruiting
Matosinhos Municipality, Portugal
Centro Materno Infantil do NorteNot Yet Recruiting
Porto, Portugal
ULSAM - Hospital de Santa LuziaRecruiting
Viana do Castelo, Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.Not Yet Recruiting
Vila Nova de Gaia, Portugal
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario CrucesRecruiting
Barakaldo, Spain
Hospital Sant Joan de DéuRecruiting
Esplugues de Llobregat, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Skånes Universitetssjukhus MalmöRecruiting
Malmo, Sweden
Universitetssjukhuset ÖrebroNot Yet Recruiting
Örebro, Sweden
Queen Elizabeth Hospital BirminghamNot Yet Recruiting
Birmingham, United Kingdom
Birmingham Children's HospitalNot Yet Recruiting
Birmingham, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Noah's Ark Children's Hospital for WalesRecruiting
Cardiff, United Kingdom
University Hospital of WalesNot Yet Recruiting
Cardiff, United Kingdom
Queen Elizabeth University HospitalNot Yet Recruiting
Glasgow, United Kingdom
Royal London HospitalRecruiting
London, United Kingdom
St. George's HospitalNot Yet Recruiting
London, United Kingdom
The John Radcliffe HospitalNot Yet Recruiting
Oxford, United Kingdom
Southampton General HospitalRecruiting
Southampton, United Kingdom