Eli Lilly Launches Phase III Clinical Trials of Baricitinib for Type 1 Diabetes

▎Armstrong

On October 29, 2025, Eli Lilly registered two Phase III clinical trials, BARICADE-PRESERVE and BARICADE-DELAY, for the JAK inhibitor Baricitinib in the treatment of Type 1 diabetes on the Clinicaltrials.gov website.

These two Phase III clinical trials are expected to enroll 300 and 150 patients with type 1 diabetes, respectively, and are anticipated to be completed in July 2028 and July 2031, respectively.

In December 2023, the phase II clinical trial data of Baricitinib for the treatment of type 1 diabetes was published in The New England Journal of Medicine. The study enrolled 91 patients with type 1 diabetes, 60 of whom received Baricitinib treatment and 31 received placebo treatment.

At Week 48 of Treatment，The median values of average C-peptide levels in the Baricitinib group and placebo were 0.65 nmol/(L·min) and 0.43 nmol/(L·min), respectively., Two Groups CalibrationThe difference afterwards is 0.13, 95%CI=0.06~0.20，P=0.001。The average daily insulin doses in the baricitinib group and placebo group were 0.41 U/(kg·d) and 0.52 U/(kg·d), respectively.. The HbA1c levels were similar in the two groups.

Summary

PreviouslyResearch shows that Baricitinib is promisingRestoring β-cell function in newly diagnosed type 1 diabetes patients holds the potential to reverse the pathological state. Based on positive data from phase II clinical trials, Eli Lilly and Company has initiated two phase III clinical trials of Baricitinib for the treatment of type 1 diabetes two years later, with expectations for its subsequent clinical progress.