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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT07222332

Run by

Eli Lilly and Company

People needed

300

Starts

2026-02-05

Expected to finish

2028-07-01

Last updated by the study team

2026-08-06

Who can join

Age: 1 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil (enrolling)
• IBTED - Tecnologia e Educação em Diabetes — São Paulo, Brazil (enrolling)
• Cendi - Endocrinologia e Diabetes — Goiânia, Brazil (enrolling)
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T — Ribeirão Preto, Brazil (enrolling)
• Instituto de Pesquisa Clinica — São Paulo, Brazil (enrolling)
• CPCLIN — São Paulo, Brazil (enrolling)
• Quanta Diagnóstico e Terapia — Curitiba, Brazil (enrolling)
• Centro De Diabetes Metabolismo E Endocrinologia — Fortaleza, Brazil (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Instituto da Crianca com Diabetes — Porto Alegre, Brazil (enrolling)
• Women's and Children's Hospital — Adelaide, Australia (enrolling)
• Perth Children's Hospital — Perth, Australia (enrolling)
• Sydney Children's Hospital — Randwick, Australia (enrolling)
• The Children's Hospital at Westmead — Westmead, Australia (enrolling)
• Austin Health - Repatriation Hospital — Heidelberg West, Australia (enrolling)
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States (enrolling)
• Ipswich Hospital — Ipswich, Australia (enrolling)
• Centro de Diabetes Curitiba — Curitiba, Brazil (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Southern Adelaide Diabetes & Endocrine Services — Oaklands Park, Australia (enrolling)
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília, Brazil (enrolling)
• The Royal Melbourne Hospital — Parkville, Australia (enrolling)
• Hospital Universitário Maria Aparecida Pedrossian — Campo Grande, Brazil (enrolling)
• Clínica Hepatogastro JK — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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