Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Efficacy and Safety of Frexalimab to Treat Newly Diagnosed Type 1 Diabetes

In this study we want to learn more about the safety and effectiveness of a drug called frexalimab to treat people with newly diagnosed type 1 diabetes.


Why this Research Matters

In Type 1 diabetes (T1D), the immune system attacks and kills the cells that make insulin. At first, some insulin is still made, but over time these cells stop working, and insulin treatment is needed. We want to know if a drug called frexalimab will help protect your insulin making cells and help the body continue to make. To do this, we are comparing the impact of frexalimab vs. a placebo drug. A placebo is an inactive substance that looks the same and is given the same way as frexalimab. You/your child will be randomly assigned to receive frexalimab or placebo, like flipping a coin. If you/your child join this study, you will come to 14 study visits at the Barbara Davis Center for Diabetes over the course of 2.5 years. At these study visits we will do a brief physical exam and ask you questions about your health. We will use a needle in your arm to take a blood sample. We will administer the study drug or placebo through an IV for the first treatment visit, and a shot for all other visits. You will be paid for your time if you decide to take part in the study.


Who can Participate

All Ages

You may be able to join this study if you are between 12 and 35 years old and were recently diagnosed with type 1 diabetes. You must come to your first study visit within the first 90 days of starting insulin. You must be willing to use birth control to avoid pregnancy the entire time you are part of the study.


Study ID

Protocol Number: 23-1391


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Peter Gottlieb, MD

Principal Investigator