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 Under 36 Years

What this Trial Is About

Researchers are evaluating whether baricitinib can delay the onset of clinical type 1 diabetes T1D in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study focuses on participants aged 1 to under 36 years who have early-stage T1D or related autoantibody markers. The goal is to understand if baricitinib can postpone the progression to stage 3 T1D over a study period lasting up to approximately five years. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study includes a double-blind design, meaning neither participants nor researchers know who is receiving the active drug or placebo. The research team will monitor participants for up to about five years to assess the time it takes to develop stage 3 T1D and other health measures. Throughout the study, participants will undergo various assessments including measurements of glucose-stimulated C-peptide, glucose levels, body measurements such as height and BMI percentile, and health surveys. Blood samples will be collected to analyze baricitinib levels and its effects on glucose metabolism. The primary outcome is the time from baseline until diagnosis of stage 3 T1D. Safety and health status will be closely observed during the study period.

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