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RecruitingPhase 3

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation in the study will last up to approximately 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether baricitinib can delay stage 3 type 1 diabetes in children and adults at high risk. Stage 3 is when type 1 diabetes causes symptoms. Taking part may last up to about 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have at least two diabetes-related autoantibodies on a past test and on a test before or during study screening. These are proteins made by the immune system that attack the body's own cells.
  • Have stage 1b or stage 2 type 1 diabetes, which are early stages of the disease.
  • Weigh at least 8 kilograms (18 pounds) at screening.

Who can't join

  • Have any other type of diabetes.
  • Have high blood pressure that is not controlled.
  • Have had a heart attack, heart disease, stroke, or heart failure.
  • Have a history of, or high risk for, blood clots in veins, diseases in which certain immune cells grow too much, or cancer.
  • Have a serious infection now or have had one recently.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

CA

FL

IA

KY

PA

VA