NCT07222332RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
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
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 preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 27 Oct 2025
- Start date
- 5 Feb 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 1 diabetes
- NCT number
- NCT07222332
- EU CT number
- 2025-522170-36-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 5 Feb 2026 to the primary completion date, Jul 2028
- 134 sites in 20 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 including gestational
- 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
Other
- Have uncontrolled high blood pressure
Who the study is looking for
- 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
Age in the registry: 1 year to 35 years · Sex: All · Does not accept healthy volunteers
Sites (134)
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 |
| Austin Health - Repatriation Hospital Coordinator of this site? Confirm its status | Heidelberg West | Australia | Recruiting |
| Ipswich Hospital Coordinator of this site? Confirm its status | Ipswich | Australia | Recruiting |
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Southern Adelaide Diabetes & Endocrine Services Coordinator of this site? Confirm its status | Oaklands Park | 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 |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | 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 de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Hospital Universitário Maria Aparecida Pedrossian Coordinator of this site? Confirm its status | Campo Grande | Brazil | Recruiting |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Quanta Diagnóstico e Terapia Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Centro De Diabetes Metabolismo E Endocrinologia 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 |
| Instituto da Crianca com Diabetes Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Universidade Federal Do Rio de Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| CPCLIN 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 |
| Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Clínica Hepatogastro JK 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 |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Recruiting |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| CIUSSS- saguenay-Lac-Saint-Jean Coordinator of this site? Confirm its status | Chicoutimi | Canada | Recruiting |
| Alberta Diabetes Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| St. Joseph's Health Care Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centricity Research Ottawa LMC Endocrinology Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| CHUL et Centre mère-enfant Soleil Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| BC Diabetes Office Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| MILAN KVAPIL s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Hannoversche Kinderheilanstalt Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel Coordinator of this site? Confirm its status | Hof | Germany | Recruiting |
| Klinikum Karlsburg Coordinator of this site? Confirm its status | Karlsburg | Germany | Recruiting |
| Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Recruiting |
| Asklepios-Klinik, Sankt Augustin GmbH Coordinator of this site? Confirm its status | Sankt Augustin | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Oulu University Hospital 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 |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Coordinator of this site? Confirm its status | Bouches-du-Rhône | France | Recruiting |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil Essonnes Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Grenoble Coordinator of this site? Confirm its status | Isère | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Pitié-Salpêtrière University Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Robert Debre University Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon – Hôpital Louis Pradel Coordinator of this site? Confirm its status | Rhône | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Aberdeen Royal Infirmary Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | 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 |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | 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 |
| Churchill 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 |
| Linn Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Rambam Health Care Campus 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 | Active, not recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Active, not 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 | Active, not recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Active, not 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 | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Università degli Studi di Messina Coordinator of this site? Confirm its status | Messina | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Active, not recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Iuhw Ichikawa General Hospital Coordinator of this site? Confirm its status | Ichikawa | Japan | Not yet recruiting |
| Saitama Medical University Hospital Coordinator of this site? Confirm its status | Iruma | Japan | Recruiting |
| Shiga General Hospital Coordinator of this site? Confirm its status | Moriyama | Japan | Not yet recruiting |
| Abeno Medical Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Sendai City Hospital - Asutonagamachi Coordinator of this site? Confirm its status | Sendai | Japan | Not yet recruiting |
| Shizuoka Children's Hospital Coordinator of this site? Confirm its status | Shizuoka | Japan | Not yet recruiting |
| Diabeter Nederland B.V. Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Helse Fonna HF Coordinator of this site? Confirm its status | Haugesund | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Umed Clinical Trials Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not 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 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 |
| ProbarE i Lund AB Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Active, not recruiting |
| Region Jaemtland Haerjedalen Coordinator of this site? Confirm its status | Ostersund | Sweden | Active, not recruiting |
| ProbarE i Stockholm AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Active, not recruiting |
| NU Hospital Group-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Uddevalla | Sweden | Active, not recruiting |
| Institute of Endocrinology and Metabolism named after Komissarenko Coordinator of this site? Confirm its status | Kiev | Ukraine | Recruiting |
| Kyiv City Endocrinological Center Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Zakarpattia Endoclinic Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Recruiting |
| Vinnytsia Regional Clinical Endocrinology Dispensary Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Barbara Davis Center for Childhood Diabetes Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| Children's Hospital of Philadelphia (CHOP) Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Tallahassee Memorial Healthcare Coordinator of this site? Confirm its status | Tallahassee | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.