Clinical Study: Type 1 Diabetes (T1D)

Status: Enrolling

Email: Diabetes@BenaroyaResearch.org

Phone: 800.888.4187

Study Summary

TrialNet is studying rezpegaldesleukin to see if it can help the body continue making insulin in people newly diagnosed with type 1 diabetes (TID) by stimulating regulatory T cells to restore immune balance.

Rezpegaldesleukin is already being studied in people with other autoimmune diseases like psoriasis and eczema. This is the first time it is being studied in people with TID.

Like all clinical research, there are benefits and risks to participating in this study. Before you join the study, a TrialNet team member will explain all potential benefits and risks and answer your questions.

Study Enrollment Timeline

Because this is the first time rezpegaldesleukin is being studied in people with T1D, the study plans to enroll participants in steps, starting with adults and moving to younger age groups. While all participants will be closely monitored throughout this study, additional safety reviews will occur. Randomization and dosing will be the same for each group.

It is estimated that it will take 3 years to enroll all groups.

Eligibility Criteria

You may be eligible to participate if you are:

• Newly diagnosed with T1D (in the past 3 months)
• Ages 18 to 45
• Your screening tests show:
  • 1 or more diabetes-related autoantibody
  • Detectable C-peptide during a mixed meal tolerance test (MMTT)

A research team member will go over the full list of eligibility criteria with you before your screening visit.

What will study participants be asked to do?

Participation in the study lasts for 1 year beginning with the treatment phase and ending after the follow-up phase.

Treatment 

Every two weeks participants will receive an injection at a study visit. In the treatment phase, there are 15 study visits in 6 months.

Follow-Up

In the follow-up phase, participants will have 3 study visits spread over the remaining 6 months.