The FDA has cleared Zucara Therapeutics’ IND application for a Phase 2a study of ZT-01 for the prevention of nocturnal hypoglycemia in patients with Type 1 Diabetes (T1D), with first patient dosing set in the third quarter of 2023.
The ZONE study is a multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, crossover study designed to evaluate the effect of ZT-01 on the frequency of nocturnal hypoglycemia in patients with T1D.
Patients will self-administer one of three doses of ZT-01, or placebo, every evening before bed each for a four-week period. Patients will be monitored for hypoglycemia events using a continuous glucose monitor.
The study’s primary endpoint is the rate of nocturnal hypoglycemic events, compared with placebo. Secondary endpoints include the number of patients experiencing adverse events and time spent in hypoglycemia, compared with placebo.
“Having demonstrated proof-of-concept and ZT-01’s ability to significantly increase glucagon release in patients with T1D, we are looking forward to showing we can prevent potentially dangerous low blood glucose levels overnight,” Susan Peers Ph.D., director of clinical and regulatory affairs with closely-held Zucara, said in a statement.
