RecruitingPhase 3NCT07222332

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

Sponsor

Eli Lilly and Company

Enrollment

300 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

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

Min Age: 1 YearMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study (BARICADE-PRESERVE) is testing whether baricitinib — a drug that calms the immune system — can help protect the remaining insulin-producing cells in people who have just been diagnosed with type 1 diabetes. The earlier treatment begins, the more beta cells may be preserved. **You may be eligible if...** - You were diagnosed with type 1 diabetes within the last 100 days - You still have at least one diabetes-related antibody - You still have some insulin-producing (beta) cell function remaining (confirmed by a C-peptide test) - You weigh at least 8 kg (18 pounds) **You may NOT be eligible if...** - You have any other type of diabetes (including gestational diabetes) - You have uncontrolled high blood pressure - You have had a heart attack, stroke, heart disease, or heart failure - You have a history of blood clots, lymphoma, or other cancers - You have a current or recent serious infection or other medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

Administered orally

DRUGPlacebo

Administered orally

Locations(132)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Women's and Children's Hospital

Adelaide, Australia

Centre for Children's Health Research

Brisbane, Australia

Austin Health - Repatriation Hospital

Heidelberg West, Australia

Ipswich Hospital

Ipswich, Australia

Royal Children's Hospital

Melbourne, Australia

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, Australia

The Royal Melbourne Hospital

Parkville, Australia

Perth Children's Hospital

Perth, Australia

Sydney Children's Hospital

Randwick, Australia

The Children's Hospital at Westmead

Westmead, Australia

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

Yvoir, Belgium

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Brazil

Quanta Diagnóstico e Terapia

Curitiba, Brazil

Centro de Diabetes Curitiba

Curitiba, Brazil

Centro De Diabetes Metabolismo E Endocrinologia

Fortaleza, Brazil

Cendi - Endocrinologia e Diabetes

Goiânia, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

Instituto da Crianca com Diabetes

Porto Alegre, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T

Ribeirão Preto, Brazil

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

Instituto de Pesquisa Clinica

São Paulo, Brazil

CPCLIN

São Paulo, Brazil

IBTED - Tecnologia e Educação em Diabetes

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

Hospital das Clinicas FMUSP

São Paulo, Brazil

CEDOES

Vitória, Brazil

Alberta Children's Hospital

Calgary, Canada

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Canada

Alberta Diabetes Institute

Edmonton, Canada

St. Joseph's Health Care

London, Canada

Centricity Research Ottawa LMC Endocrinology

Ottawa, Canada

CHUL et Centre mère-enfant Soleil

Québec, Canada

BC Diabetes Office

Vancouver, Canada

Nemocnice Jihlava

Jihlava, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, Czechia

New Children's Hospital

Helsinki, Finland

Oulun yliopistollinen sairaala

Oulu, Finland

Tampereen yliopistollinen sairaala

Tampere, Finland

Turku University Hospital

Turku, Finland

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Hopital Claude Huriez - CHU de Lille

Lille, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, France

Pitie Salpetriere University Hospital

Paris, France

Hôpital Universitaire Necker Enfants Malades

Paris, France

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T

Paris, France

CHU Rangueil

Toulouse, France

Hannoversche Kinderheilanstalt

Hanover, Germany

Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel

Hof, Germany

Klinikum Karlsburg

Karlsburg, Germany

Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

Ludwigshafen am Rhein, Germany

TUM Klinikum

München, Germany

RED-Institut GmbH

Oldenburg, Germany

Asklepios Klinik Sankt Augustin

Sankt Augustin, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Yitzhak Shamir Medical Center

Beer Yaacov, Israel

Soroka Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Linn Medical Center

Haifa, Israel

Institute of Diabetes, Technology and Research - Clalit Health

Herzliya, Israel

Hadassah Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Sourasky Medical Center

Tel Aviv, Israel

Ospedale Pediatrico Salesi

Ancona, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Italy

Azienda Ospedaliera Universitaria Di Messina G. Martino

Messina, Italy

Ospedale San Raffaele

Milan, Italy

University of Naples Federico II

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Azienda Ospedale - Università Padova

Padova, Italy

Azienda Ospedale - Università Padova

Padova, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy

Diabeter - Rotterdam

Rotterdam, Netherlands

Helse Fonna - Haugesund Sjukehus

Haugesund, Norway

Akershus Universitetssykehus

Lørenskog, Norway

Oslo Universitetssykehus Aker

Oslo, Norway

Oslo Universitetssykehus Ullevål

Oslo, Norway

Stavanger Universitetssykehus

Stavanger, Norway

St. Olavs Hospital

Trondheim, Norway

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

UMED Clinical Trials

Lodz, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland

2Ca Braga

Braga, Portugal

Centro Materno Infantil do Norte

Porto, Portugal

ULSAM - Hospital de Santa Luzia

Viana do Castelo, Portugal

Unidade Local De Saude De Gaia/Espinho E.P.E.

Vila Nova de Gaia, Portugal

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

ProbarE i Lund AB

Lund, Sweden

Universitetssjukhuset Örebro

Örebro, Sweden

Östersunds Sjukhus

Östersund, Sweden

ProbarE i Stockholm AB

Stockholm, Sweden

Uddevalla Sjukhus

Uddevalla, Sweden

Institute of Endocrinology and Metabolism named after Komissarenko

Kiev, Ukraine

Kyiv City Endocrinological Center

Kyiv, Ukraine

Zakarpattia Endoclinic

Uzhhorod, Ukraine

Vinnytsia Regional Clinical Endocrinology Dispensary

Vinnytsia, Ukraine

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Birmingham Children's Hospital

Birmingham, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07222332

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