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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Baricitinib; Drug: Placebo

• Registration Number: NCT07222137
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-29
• Last Update Posted: 2025-10-29
• Study Start: 2026-01-01
• Primary Completion: 2031-07
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib	Participants will receive baricitinib orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes	Baseline up to approximately 5 years

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Matsuda Index	Baseline, Week 52
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

Trial Locations

Locations (105)

Tallahassee Memorial HealthCare; 🇺🇸 Tallahassee, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

Novak Center for Children's Health; 🇺🇸 Louisville, Kentucky, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia (CHOP); 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Women's and Children's Hospital; 🇦🇺 Adelaide, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Australia

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