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

NCT07222332 · Eli Lilly and Company
In plain English

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Official title
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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Allocation: randomized
Masking: double
Age groups: child, adult
Timeline
Starts: 2026-02-05
Estimated completion: 2028-07
Last updated: 2026-04-17
Interventions
Drug: BaricitinibDrug: Placebo
Primary outcomes
  • Change from Baseline in C-peptide Area Under the Curve (AUC) (Baseline, Week 52)
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 · 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 (132)
Barbara Davis Center for Childhood DiabetesNot Yet Recruiting
Aurora, Colorado, United States
Tallahassee Memorial HealthCareNot Yet Recruiting
Tallahassee, Florida, United States
Children's Hospital of Philadelphia (CHOP)Not Yet Recruiting
Philadelphia, Pennsylvania, United States
Driscoll Children's HospitalNot Yet Recruiting
Corpus Christi, Texas, United States
University of VirginiaNot Yet Recruiting
Charlottesville, Virginia, United States
Women's and Children's HospitalRecruiting
Adelaide, Australia
Centre for Children's Health ResearchNot Yet Recruiting
Brisbane, Australia
Austin Health - Repatriation HospitalRecruiting
Heidelberg West, Australia
Ipswich HospitalNot Yet Recruiting
Ipswich, Australia
Royal Children's HospitalNot Yet Recruiting
Melbourne, Australia
Southern Adelaide Diabetes & Endocrine ServicesRecruiting
Oaklands Park, Australia
The Royal Melbourne HospitalRecruiting
Parkville, Australia
Perth Children's HospitalNot Yet Recruiting
Perth, Australia
Sydney Children's HospitalNot Yet Recruiting
Randwick, Australia
The Children's Hospital at WestmeadNot Yet Recruiting
Westmead, Australia
Université Libre de Bruxelles - Hôpital ErasmeNot Yet Recruiting
Brussels, Belgium
UZ BrusselNot Yet Recruiting
Brussels, Belgium
Cliniques universitaires Saint-LucNot Yet Recruiting
Brussels, Belgium
Antwerp University HospitalNot Yet Recruiting
Edegem, Belgium
UZ GentNot Yet Recruiting
Ghent, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanNot Yet Recruiting
Liège, Belgium
CHU UCL Namur/Site Sainte ElisabethNot Yet Recruiting
Namur, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneNot Yet Recruiting
Yvoir, Belgium
Hospital Universitário Maria Aparecida PedrossianNot Yet Recruiting
Campo Grande, Brazil
Quanta Diagnóstico e TerapiaNot Yet Recruiting
Curitiba, Brazil
Centro de Diabetes CuritibaNot Yet Recruiting
Curitiba, Brazil
Centro De Diabetes Metabolismo E EndocrinologiaNot Yet Recruiting
Fortaleza, Brazil
Cendi - Endocrinologia e DiabetesNot Yet Recruiting
Goiânia, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIMNot Yet Recruiting
Marília, Brazil
Instituto da Crianca com DiabetesNot Yet Recruiting
Porto Alegre, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -TNot Yet Recruiting
Ribeirão Preto, Brazil
Universidade Federal do Rio de JaneiroNot Yet Recruiting
Rio de Janeiro, Brazil
Instituto de Pesquisa ClinicaNot Yet Recruiting
São Paulo, Brazil
CPCLINNot Yet Recruiting
São Paulo, Brazil
IBTED - Tecnologia e Educação em DiabetesNot Yet Recruiting
São Paulo, Brazil
Clínica Hepatogastro JKNot Yet Recruiting
São Paulo, Brazil
Hospital das Clinicas FMUSPNot Yet Recruiting
São Paulo, Brazil
CEDOESNot Yet Recruiting
Vitória, Brazil
Alberta Children's HospitalNot Yet Recruiting
Calgary, Canada
CIUSSS- saguenay-Lac-Saint-JeanNot Yet Recruiting
Chicoutimi, Canada
Alberta Diabetes InstituteNot Yet Recruiting
Edmonton, Canada
St. Joseph's Health CareNot Yet Recruiting
London, Canada
Centricity Research Ottawa LMC EndocrinologyNot Yet Recruiting
Ottawa, Canada
CHUL et Centre mère-enfant SoleilNot Yet Recruiting
Québec, Canada
BC Diabetes OfficeNot Yet Recruiting
Vancouver, Canada
Nemocnice JihlavaRecruiting
Jihlava, Czechia
Fakultni nemocnice OstravaRecruiting
Ostrava, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulanceRecruiting
Prague, Czechia
New Children's HospitalNot Yet Recruiting
Helsinki, Finland
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
Centre Hospitalier Universitaire de GrenobleNot Yet Recruiting
Grenoble, 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
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
Hannoversche KinderheilanstaltNot Yet Recruiting
Hanover, Germany
Schwerpunktpraxis für Diabetes Hormone & StoffwechselRecruiting
Hof, Germany
Klinikum KarlsburgNot Yet Recruiting
Karlsburg, Germany
Diabetologikum Ludwigshafen/Die Praxis am LudwigsplatzRecruiting
Ludwigshafen am Rhein, Germany
TUM KlinikumRecruiting
München, Germany
RED-Institut GmbHRecruiting
Oldenburg, Germany
Asklepios Klinik Sankt AugustinRecruiting
Sankt Augustin, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Yitzhak Shamir Medical CenterRecruiting
Beer Yaacov, Israel
Soroka Medical CenterNot Yet Recruiting
Beersheba, Israel
Rambam Health Care CampusNot Yet Recruiting
Haifa, Israel
Linn Medical CenterNot Yet Recruiting
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 CenterNot Yet Recruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Ospedale Pediatrico SalesiNot Yet Recruiting
Ancona, Italy
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Italy
Azienda Ospedaliera Universitaria Meyer IRCCSNot Yet Recruiting
Florence, Italy
Azienda Ospedaliera Universitaria Di Messina G. MartinoRecruiting
Messina, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, 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 Ospedale - Università PadovaNot Yet Recruiting
Padova, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoRecruiting
Verona, Italy
Diabeter - RotterdamNot Yet Recruiting
Rotterdam, Netherlands
Helse Fonna - Haugesund SjukehusNot Yet Recruiting
Haugesund, Norway
Akershus UniversitetssykehusNot Yet Recruiting
Lørenskog, Norway
Oslo Universitetssykehus AkerNot Yet Recruiting
Oslo, Norway
Oslo Universitetssykehus UllevålNot Yet Recruiting
Oslo, Norway
Stavanger UniversitetssykehusNot Yet Recruiting
Stavanger, Norway
St. Olavs HospitalNot Yet Recruiting
Trondheim, Norway
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
UMED Clinical TrialsNot Yet Recruiting
Lodz, Poland
MTZ Clinical Research Powered by PratiaRecruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuNot Yet Recruiting
Wroclaw, Poland
2Ca BragaRecruiting
Braga, 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 Clínic de BarcelonaRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Sant Joan de DéuRecruiting
Esplugues de Llobregat, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Spain
Hospital Universitario Virgen Del RocioNot Yet Recruiting
Seville, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain
Hospital Universitari i Politecnic La FeNot Yet Recruiting
Valencia, Spain
ProbarE i Lund ABNot Yet Recruiting
Lund, Sweden
Universitetssjukhuset ÖrebroNot Yet Recruiting
Örebro, Sweden
Östersunds SjukhusNot Yet Recruiting
Östersund, Sweden
ProbarE i Stockholm ABNot Yet Recruiting
Stockholm, Sweden
Uddevalla SjukhusNot Yet Recruiting
Uddevalla, Sweden
Institute of Endocrinology and Metabolism named after KomissarenkoRecruiting
Kiev, Ukraine
Kyiv City Endocrinological CenterRecruiting
Kyiv, Ukraine
Zakarpattia EndoclinicRecruiting
Uzhhorod, Ukraine
Vinnytsia Regional Clinical Endocrinology DispensaryRecruiting
Vinnytsia, Ukraine
Aberdeen Royal InfirmaryRecruiting
Aberdeen, United Kingdom
Queen Elizabeth Hospital BirminghamNot Yet Recruiting
Birmingham, United Kingdom
Birmingham Children's HospitalNot Yet Recruiting
Birmingham, United Kingdom
Southmead HospitalRecruiting
Bristol, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
University Hospital of WalesRecruiting
Cardiff, United Kingdom
Churchill HospitalNot Yet Recruiting
Oxford, United Kingdom
Southampton General HospitalRecruiting
Southampton, United Kingdom
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) · TrialPath