Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus - Ages 8-17

STUDY BASICS

Are you the parent of a child that has developed type 1 diabetes (T1D) within the last 3 months. Your child may be eligible to join a research study testing a drug called Rezpegaldesleukin to see if it will preserve insulin secretion after diagnosis of type 1 diabetes (T1D). After screening, if your child is eligible and decides to enroll, participation will be for about one year.

STUDY PURPOSE

The goal of this study is to see if Rezpegaldesleukin can help delay or stop further destruction of the remaining beta cells in people who have recently been diagnosed with T1D.  If this treatment is helpful in people with newly diagnosed T1D it may be studied further in earlier stages of T1D see if it can delay or prevent the disease from developing.

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• are between the ages of 8 and 17
• has developed type 1 diabetes (T1D) within the last 3 months

WHAT PARTICIPANTS CAN EXPECT

Participants will be placed into one of these groups by chance (similar to flipping a coin or drawing straws).  There are two treatment groups:

• 2 out of 3 participants will receive the study treatment (Rezpegaldesleukin).
• 1 out of 3 will receive a placebo (which looks like the study treatment but is an inactive substance).

The study treatment is given as an injection (a shot) every 2 weeks.

In addition to receiving the study medication, study procedures include

• Questionnaires
• Physical exam
• Collection of blood and urine samples
• Mixed Meal Tolerance Test