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

NCT07222137

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Diabetes Mellitus, Type 1

Interventions: Baricitinib, Placebo

Countries: United States, Australia, Belgium, Brazil, Canada, Finland, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 35 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (111)
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Iowa City, Iowa, United States
  • West Des Moines, Iowa, United States
  • Louisville, Kentucky, United States
  • Philadelphia, Pennsylvania, United States
  • Charlottesville, Virginia, United States
  • Adelaide, Australia
  • Box Hill, Australia
  • Brisbane, Australia
  • Brisbane, Australia
  • Melbourne, Australia
  • Parkville, Australia
  • Perth, Australia
  • Randwick, Australia
  • Westmead, Australia
  • Brussels, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Leuven, Belgium
  • Namur, Belgium
  • Belo Horizonte, Brazil
  • Curitiba, Brazil
  • Fortaleza, Brazil
  • Goiânia, Brazil
  • Marília, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • + 81 more on CT.gov