Cirius Therapeutics Inc, a developer of innovative therapies for people suffering from diseases caused by mitochondrial dysfunction and insulin resistance, announced on Wednesday that enrolment and dosing has begun in a Phase 2 clinical study (CTI-0602K-201A) evaluating CIR-0602K in adults with type 1 diabetes (T1D) treating their T1D with automated insulin delivery (AID).
The randomised, double-blind, placebo-controlled study will enrol approximately 34 participants to receive either CIR-0602K or placebo tablets daily for three months. It is a signal-finding study designed to show improved glucose time-in-range and supported by a research award from Breakthrough T1D.
According to Cirius, CIR-0602K is designed to improve insulin sensitivity – and mitochondrial dysfunction – by targeting mitochondrial metabolism. In prior clinical studies in people living with T2D, CIR-0602K simultaneously improved glycaemic control and reduced insulin resistance by approximately 50%. In addition, it reduced systemic inflammation and other biomarkers of cardiometabolic disease. The study will test whether this is also true in people living with T1D, and whether it can help reduce the related cardiovascular dysfunctions. If successful, this study will help accelerate development of CIR-0602K across diabetes.
Topline data is expected in the second half of 2027.
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