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Taking people in CanadaPhase 3

Tests baricitinib to delay type 1 diabetes in people at high risk

Tests baricitinib against placebo in people at high risk of type 1 diabetes.

Key facts

Who runs it
Eli Lilly and Company
Where
Calgary, Edmonton, and Vancouver, CanadaSee the 3 sitesAlso in 18 other countries, 106 sites
Trial code
Registry title
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
12 Jan 2026
Expected to end
Jul 2031
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Baricitinib
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and adults aged 1 to 35 years who are at high risk of type 1 diabetes. It tests whether baricitinib can delay the start of clinical type 1 diabetes.

Age
1 year to 35 years
Sex
All sexes can join.
Disease stage
Stage 1b or Stage 2 type 1 diabetes, with at least two diabetes-related autoantibodies.
Biomarker or test result
At least two diabetes-related autoantibodies, documented before and also at screening or prescreening.

Main reasons for not taking part

  • Any other type of diabetes
  • Uncontrolled high blood pressure
  • Heart attack, heart disease, stroke or heart failure
  • History or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
  • Current or recent clinically serious infection

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have any other type of diabetes
  • 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
  • Have uncontrolled high blood pressure

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 35 years old?

Where in Canada

Also in 18 other countries, 106 sites

  • Alberta Children's HospitalCalgary, CanadaContact: Carol Huang (principal investigator)Not yet recruiting
  • Alberta Diabetes InstituteEdmonton, CanadaContact: Peter Senior (principal investigator)Taking people
  • BC Diabetes OfficeVancouver, CanadaContact: Thomas Elliott (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • BaricitinibTreatment being tested

    Participants will receive baricitinib orally

  • PlaceboPlacebo, for comparison

    Participants will receive placebo orally

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests baricitinib to delay type 1 diabetes in people at high riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07222137, who can take part
Record updated
4 November 2026