Study Details Currently Enrolling

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.

Who Can Participate

  • 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.

Randomization

This study will enroll 66 participants newly diagnosed with T1D.

  • 2 out of every 3 participants (44 people) will receive the study drug.
  • 1 out of every 3 participants (22 people) will receive a placebo (looks like the study drug but has no active ingredients); this is the control group.

A computer randomly selects who receives the study drug. The participants and the study team will not know who received the study drug and who received the placebo until the study ends.

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.

The study is currently enrolling:

Ages 18 - 45

About 18 participants are expected in this group. There will be an added safety review to help decide if children age 12 and up should be allowed to join the next group.

 

Participant Experience

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

1 Year in the RESET T1D Study

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.
 

How to Sign Up

You can let us know that you’re interested in the RESET T1D Study by filling out this form. A member of the TrialNet research team will contact you to discuss your eligibility. If this study isn’t right for you, we’ll let you know about other current or upcoming new onset studies.

For more information about this study or TrialNet, please email us: info@trialnet.org.

 

Benefits of Being in this Study

While in this study, participants will receive intensive diabetes management. Studies have shown that keeping blood glucose levels within a healthy range reduces the risk of long-term complications. It may also help any remaining beta cells continue to make some insulin.

 

Key Terms

Most study visits include routine tests (such as physical, blood tests, urine collection). Some visits will include a Mixed Meal Tolerance Test (MMTT) and an electrocardiogram (ECG). After some visits, a participant will wear a continuous glucose monitor (CGM) for 7 days. If a participant does not have a CGM, we will provide one.

A MMTT measures how much insulin the body is making. It starts with drinking a liquid meal that has proteins, fats and carbohydrates, then a blood draw. An intravenous catheter is used, so there’s only one poke while small amounts of blood are collected over a 2-hour period.

An ECG is a quick test that records the electrical activity of the heart. Sticky patches called electrodes are placed on the chest, arms and legs and capture electrical signals from the heart for 10 seconds. The test does not hurt.

A CGM checks blood glucose every 5 minutes. To wear a CGM sensor, a small needle that has a catheter is placed just under the skin, typically in the participant's hip or stomach. Once the sensor has been inserted, the needle is removed and a very tiny catheter stays under the skin. Then a transmitter is attached to the CGM.