A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

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 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.

Key facts

Study ID

NCT07222137

Run by

Eli Lilly and Company

People needed

150

Starts

2026-01-12

Expected to finish

2031-07-01

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 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

You may not qualify if…

• Have any other type of diabetes
• 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 infection

Where it is running

• Hospital das Clinicas FMUSP — São Paulo, Brazil (enrolling)
• Oulun yliopistollinen sairaala — Oulu, Finland (enrolling)
• Instituto de Pesquisa Clinica — São Paulo, Brazil (enrolling)
• IBTED - Tecnologia e Educação em Diabetes — São Paulo, Brazil (enrolling)
• BC Diabetes Office — Vancouver, Canada (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (enrolling)
• Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil (enrolling)
• CPCLIN — São Paulo, Brazil (enrolling)
• Centre for Children's Health Research — Brisbane, Australia (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• The Royal Melbourne Hospital — Parkville, 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)
• Women's and Children's Hospital — Adelaide, Australia (enrolling)
• Box Hill Hospital — Box Hill, Australia (enrolling)
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília, Brazil (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Royal Brisbane and Women's Hospital — Brisbane, Australia (enrolling)
• Freire Pesquisa Clínica — Belo Horizonte, Brazil (enrolling)
• Centro de Diabetes Curitiba — Curitiba, Brazil (enrolling)
• Hospital Universitario Walter Cantidio — Fortaleza, Brazil (enrolling)
• Cendi - Endocrinologia e Diabetes — Goiânia, Brazil (enrolling)
• Tampereen yliopistollinen sairaala — Tampere, Finland (enrolling)

Full record on ClinicalTrials.gov

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