Recruiting soon

Baricitinib for Beta Cell Preservation in Newly Diagnosed Type 1 Diabetes

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Baricitinib

+ Placebo

Drug
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 1 to 35 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study aims to determine if a medication called baricitinib can help maintain the function of beta cells in people who have recently been diagnosed with type 1 diabetes. Beta cells are responsible for producing insulin, which is crucial for managing blood sugar levels. The study focuses on individuals aged 1 to 35 years who have just been diagnosed with type 1 diabetes. By potentially preserving beta cell function, the study hopes to improve long-term health outcomes and manage diabetes more effectively for these patients. Participants in the study will receive either baricitinib or a placebo over a period of about 60 weeks. The treatment is given in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual medication and who is getting the placebo. This approach helps ensure the results are unbiased. The main focus is to observe changes in beta cell function, which may influence how well the body can regulate blood sugar levels. As with any medical study, there may be risks and benefits associated with the treatment, which will be closely monitored by the research team.

Official TitleA Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
NCT07222332
Principal SponsorEli Lilly and Company
Study ContactThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Have at least one diabetes-related autoantibody found at screening

Weigh at least 8 kilograms (kg) (18 pounds) at screening

Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention

Show signs of remaining beta-cell function (stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening, or random C-peptide result >0.3 nmol/L (0.9 ng/mL) during the screening period)

5 exclusion criteria prevent from participating
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 uncontrolled high blood pressure

Have a current or recent clinically serious medical condition or infection

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive baricitinib orally

Group II

Placebo
Participants will receive placebo orally

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 128 locations

Suspended

Barbara Davis Center for Childhood Diabetes

Aurora, United StatesOpen Barbara Davis Center for Childhood Diabetes in Google Maps
Suspended

Children's Hospital of Philadelphia (CHOP)

Philadelphia, United States
Suspended

Driscoll Children's Hospital

Corpus Christi, United States
Suspended

University of Virginia

Charlottesville, United States
Recruiting soon128 Study Centers