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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT07222137

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Baricitinib (drug), Placebo (drug)
How long the study runs
Study runs about 66 months (dates as stated)
About the drug or intervention
Baricitinib — drug: Administered orally · Placebo — drug: Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
1 Year to 35 Years
Who
All
Number of participants
150
Started
2026-01-12
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes mellitus, type 1
  • • Phase3 - 150 participants
  • • 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

Who can take part?

  • • Ages 1 Year to 35 Years
  • • Diagnosed with diabetes mellitus, type 1

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Birmingham - Birmingham Children's Hospital
  • • Cambridge - Addenbrooke's Hospital
  • • Cardiff - Noah's Ark Children's Hospital for Wales
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Diabetes Mellitus, Type 1

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Year - 35 Years
  • Who can join: All genders

What the study is looking for

  • ✓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 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 cancer
  • ✗Have a current or recent clinically serious infection
See the full 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

Where Is This Study? (10 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
parth narendranPrincipal Investigator

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Renuka DiasPrincipal Investigator

Addenbrooke's Hospital

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Mark EvansPrincipal Investigator

Noah's Ark Children's Hospital for Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Ambika ShettyPrincipal Investigator

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Maitrayee ChoudhuryPrincipal Investigator

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Rajeeb RashidPrincipal Investigator

Royal London Hospital

London E1 1BB, United Kingdom

Recruiting
Site contact (verified)
Ruben WillemsenPrincipal Investigator

St. George's Hospital

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)
Mimi ChenPrincipal Investigator

The John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Rachel BesserPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Nicola TrevelyanPrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10