Upcoming Clinical Trials

Tolerion is developing new treatments for Type 1 Diabetes (T1D) and other diseases and conditions caused by unwanted immune responses. Our lead product, TOL-3021, aims to control the autoimmune condition that leads to T1D. A 12-week study of 80 patients with T1D showed preliminary evidence suggesting that TOL-3021 improves insulin secretion by reducing the immune attack on insulin-producing beta cells. Tolerion is progressing TOL-3021 to advanced clinical development to definitively evaluate the safety and efficacy of TOL-3021 in patients with T1D.

The SUNRISE Trial
SUNRISE is a multi-center, randomized, double-blind, placebo-controlled trial to further evaluate the safety and efficacy of TOL-3021 in both recently diagnosed and established patients with T1D. The impact of TOL-3021 on endogenous secretion of insulin and other disease-relevant measures will be assessed over 52 weeks.

The DAWN Trial
DAWN (Diabetes Autoimmunity Withdrawn in New-onset patients) is a multi-center, randomized, double-blind, placebo-controlled pivotal trial to further evaluate the safety and efficacy of TOL-3021 in patients recently diagnosed with T1D. The impact of TOL-3021 on endogenous secretion of insulin and other disease-relevant measures will be assessed over 52 weeks.

The DAY Trial
DAY (Diabetes AutoimmunitY withdrawn in established patients) is a multi-center, randomized, double-blind, placebo-controlled pivotal trial to further evaluate the safety and efficacy of TOL-3021 in patients with established T1D. The impact of TOL-3021 on endogenous secretion of insulin and various other disease-relevant measures will be assessed over 52 weeks.