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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07222137

Acronym

BARICADE-DELAY

Enrollment

150

Registered

2025-10-29

Start date

2026-01-12

Completion date

2031-07-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

DRUGBaricitinib

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes	Baseline up to approximately 5 years

Secondary

Measure	Time frame
Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC)	Baseline, Week 52
Change from Baseline in Glucose AUC	Baseline, Week 52
Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000)	Baseline, Week 52
Change from Baseline in Height	Baseline, Week 52
Change from Baseline in Body Mass Index (BMI) Percentile	Baseline, Week 52
Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive)	Baseline, Week 52
Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)	Baseline, Week 52
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib	Predose through Week 24
PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib	Predose through Week 24
Change from Baseline in Matsuda Index	Baseline, Week 52

Countries

Australia, Belgium, Brazil, Canada, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, United Kingdom, United States

Contacts

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

LillyTrials@Lilly.com1-317-615-4559

CONTACTPhysicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026