A new clinical study is testing rezpegaldesleukin to see if it can help people recently diagnosed with type 1 diabetes continue to make insulin by resetting the body's natural immune balance. Rezpegaldesleukin has already shown promising results in clinical trials for other autoimmune diseases, including atopic dermatitis and lupus. This is the first time it is being studied in people with type 1 diabetes.

The RESET T1D study is being conducted by TrialNet, a National Institutes of Health-funded clinical trial network at the forefront of type 1 diabetes research.

“Based on findings from studies focusing on other autoimmune diseases, we are eager to determine whether rezpegaldesleukin can also improve immune regulation in type 1 diabetes,” said Daniel Moore, MD, PhD, Co-chair of the RESET T1D study and TrialNet Principal Investigator at Vanderbilt University in Nashville. “This treatment specifically targets improving regulatory T cell (Treg) function, which is thought to play an important role in type 1 diabetes. The RESET T1D study will provide us with a better understanding of this therapy specifically and Tregs generally in type 1 diabetes.”

RESET T1D will enroll 66 individuals who have been recently diagnosed with type 1 diabetes (within 100 days of diagnosis). Two-thirds of the participants will receive the study drug; the remaining third will receive a placebo. Because this is the first time rezpegaldesleukin is being studied in people with type 1 diabetes, participants will be enrolled in small groups, starting with adults aged 18-45. After safety reviews, researchers plan to lower the minimum age to 12 and then to 8.

During the treatment phase, participants will receive an injection every two weeks for six months. Then they’ll be monitored for six months. All participants will receive close monitoring.

“Any intervention that can preserve insulin production is significant,” said Megan Levings, PhD, RESET T1D Study Co-chair and TrialNet Principal Investigator at British Columbia Children’s Hospital in Vancouver. “People who continue to make even a small amount of insulin find it easier to maintain their blood sugar levels, which reduces the risk of long-term complications.” Complications of type 1 diabetes can include eye, nerve, and kidney damage.

To learn more about the RESET T1D study or to find the nearest participating TrialNet Clinical Center, visit trialnet.org/reset-t1d.

About TrialNet

TrialNet (NCT00097292), the largest clinical trial network ever assembled to change the course of type 1 diabetes, is funded by the National Institutes of Health (NIH), primarily through the Special Statutory Funding Program for Type 1 Diabetes. TrialNet data collected from more than 250,000 relatives of people with type 1 diabetes over 20 years led to the development of the stages of type 1 diabetes, making it possible to identify who will develop the disease and advancing prevention research. Additionally, TrialNet conducted the clinical study that discovered teplizumab could delay type 1 diabetes for 2+ years, leading to the FDA’s approval of the first drug to delay type 1 diabetes in people at risk. TrialNet offers free risk screening to relatives of people with type 1 diabetes and innovative clinical studies testing ways to slow down and prevent disease progression. Learn more at www.trialnet.org.