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
- Diseases
- Type 1 diabetes
- 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
Sites (109)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Women's and Children's Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Centre for Children's Health Research Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Antwerpen | Belgium | Recruiting |
| Cliniques Universitaries Saint Luc Coordinator of this site? Confirm its status | Bruxelles-Capitale | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Freire Pesquisa Clinica Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Hospital Universitario Walter Cantidio Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Cendi - Endocrinologia e Diabetes Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM Coordinator of this site? Confirm its status | Marília | Brazil | Recruiting |
| Universidade Federal Do Rio de Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| IBTED - Tecnologia e Educação em Diabetes Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Alberta Diabetes Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| BC Diabetes Office Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| KJF Klinik Josefinum gGmbH Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Hannoversche Kinderheilanstalt Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| TUM Klinikum Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Pohjois-Pohjanmaan hyvinvointialue Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Varsinais-Suomen hyvinvointialue Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Hospices Civils de Lyon - Hopital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil Essonnes Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Robert Debre University Hospital Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Hopitaux Universitaires Paris Centre-Hopital Cochin Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Pitié-Salpêtrière University Hospital Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Noah's Ark Children's Hospital for Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| St. George's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Recruiting |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Beer Yaacov | Israel | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Carmel Hospital Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Institute of Diabetes, Technology and Research - Clalit Health Coordinator of this site? Confirm its status | Herzliya | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Locale N. 8 Di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Abeno Medical Clinic Coordinator of this site? Confirm its status | Abeno | Japan | Recruiting |
| Saitama Medical University Hospital Coordinator of this site? Confirm its status | Iruma | Japan | Recruiting |
| Nippon Medical School Musashi Kosugi Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Yamanashi Prefectural Central Hospital Coordinator of this site? Confirm its status | Kofu | Japan | Recruiting |
| Seino Internal Medicine Clinic Coordinator of this site? Confirm its status | Kōriyama | Japan | Recruiting |
| Jinnouchi Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Nagano Municipal Hospital Coordinator of this site? Confirm its status | Nagano | Japan | Recruiting |
| Nakakinen clinic Coordinator of this site? Confirm its status | Naka | Japan | Recruiting |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Diabeter Nederland B.V. Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Unidade Local De Saude De Matosinhos E.P.E. Coordinator of this site? Confirm its status | Senhora Da Hora | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Minho E.P.E. Coordinator of this site? Confirm its status | Viana do Castelo | Portugal | Recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Recruiting |
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Not yet recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Novak Center for Children's Health Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Children's Hospital of Philadelphia (CHOP) Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Sansum Diabetes Research Institute Coordinator of this site? Confirm its status | Santa Barbara | United States | Not yet recruiting |
| Tallahassee Memorial Healthcare Coordinator of this site? Confirm its status | Tallahassee | United States | Recruiting |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.