CIR-0602K Begins Dosing in Breakthrough T1D-Supported Phase 2 in Type 1 Diabetes
- Randomized placebo-controlled study
- Assessing 3 months of CIR-0602K for increasing glucose time-in-range, reducing HbA1c and total daily insulin dose, and improving cardiovascular biomarkers and vascular function
- Supported by Breakthrough T1D and ongoing at University of Virginia School of Medicine
- Topline data expected in the second half of 2027
GRAND RAPIDS, Mich., June 24, 2026 /PRNewswire/ -- Cirius Therapeutics, Inc., a developer of innovative therapies for people suffering from diseases caused by mitochondrial dysfunction and insulin resistance, today announced enrollment and dosing has begun in a Phase 2 clinical study (CTI-0602K-201A, NCT07186660) evaluating CIR-0602K in adults with type 1 diabetes (T1D) treating their T1D with automated insulin delivery (AID).
The randomized, double-blind, placebo-controlled study is actively recruiting and will enroll approximately 34 participants to receive either CIR-0602K or placebo tablets daily for three months. It is a signal-finding study powered to show improved glucose time-in-range and supported by a research award from Breakthrough T1D.
"Beginning treatment in these first participants marked an important milestone for this study and for our broader effort to address a major unmet need across diabetes," said Robert A. Beardsley, Ph.D., President and Chief Executive Officer of Cirius. "We are also developing CIR-0602K for treatment of type 2 diabetes (T2D), as well as our recently announced initiative to prevent T2D in women who experienced gestational diabetes during their pregnancies, supported with funding from the Gates Foundation. By treating insulin resistance, potentially preserving pancreatic beta cell function, and, more broadly, correcting mitochondrial dysfunction, we believe CIR-0602K can offer significant contributions to treating T1D, T2D and other cardiometabolic disease."
Automated insulin delivery systems have significantly improved glycemic control in T1D, yet many patients continue to require high insulin doses and fail to consistently achieve target glucose ranges. For this study, glucose time-in-range (70-180 mg/dL) via continuous glucose monitoring is the primary endpoint. Key secondary and exploratory endpoints include HbA1c, total daily insulin dose, insulin sensitivity (by euglycemic insulin clamp), markers of vascular function and other cardiometabolic biomarkers.
Insulin resistance in people with T1D contributes to suboptimal glycemic control and higher total daily insulin requirements. These factors, along with related mitochondrial dysfunction, are linked to systemic inflammation, vascular dysfunction and long-term cardiovascular risk.
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 glycemic 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.
"In T1D, unresolved mitochondrial dysfunction contributes to insulin resistance and cardiovascular complications," said Dr. Jerry Colca, Ph.D., Chief Scientific Officer of Cirius. "In addition, while exogenous insulin is essential for people with T1D, it is now known that requirements for higher insulin levels can interfere with the ability to control glucose in the optimal range and impact cardiovascular function. CIR-0602K offers a potential solution by correcting insulin resistance and the underlying mitochondrial dysfunction, leading to better glycemic control with less insulin and potentially improving cardiovascular outcomes."
This Phase 2 study is being conducted at the University of Virginia School of Medicine.
"Closed-loop systems have meaningfully improved glycemic management in T1D, but they do not address underlying intrinsic insulin resistance," said Dr. William B. Horton, M.D., Associate Professor of Medicine in the University of Virginia School of Medicine's Division of Endocrinology and Metabolism and Principal Investigator for the study. "Even with the latest automated insulin delivery, insulin resistance and the accompanying cardio-metabolic derangements associated with T1D lead to a risk of cardiovascular and other complications more than twice that of non-diabetics. The high level of interest in participating in this study reflects the desire of people living with T1D to address this."
Topline data is expected in the second half of 2027.
About Cirius
Cirius is a clinical-stage pharmaceutical company focusing on metabolic health via targeting mitochondrial pyruvate carrier (MPC), addressing the mitochondrial dysfunction that causes insulin resistance and the organ pathologies associated with type 2 diabetes (T2D), type 1 diabetes (T1D) and obesity/overweight. Its lead product candidate, CIR-0602K, is a potential best-in-class novel small molecule being developed as a once-daily oral therapy designed to selectively inhibit the mitochondrial target MPC, which plays a central role in selecting mitochondrial energy substrates. MPC inhibition reprograms mitochondrial metabolism, reducing insulin resistance in cells and driving metabolic benefits in organs throughout the body. This markedly improves glycemic control in diabetes, body composition in obesity, liver function and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), and outcomes in cardiometabolic disorders.
About CIR-0602K
CIR-0602K has completed 7 US clinical trials including a 52-week placebo-controlled Phase 2b study in 392 participants with MASH with and without T2D, and a 28-day placebo-controlled Phase 2a study in 129 participants with T2D. In those clinical studies it lowered HbA1c and insulin levels, and reduced liver injury and MASH – including on top of existing GLP-1 therapy. A pilot clinical study also showed CIR-0602K markedly reduces HbA1c, insulin levels and fat in muscle, and increases muscle metabolic function in people with obesity & T2D. A Phase 2a study in people with type 1 diabetes (T1D) and supported by Breakthrough T1D has begun dosing. Cirius also recently announced that the Gates Foundation is providing a grant to initiate clinical studies as a potential postpartum therapeutic for women with a history of gestational diabetes mellitus (GDM).
Preclinical studies also demonstrate increased lean muscle mass, strength and metabolic function, together with metabolically beneficial shifts in adipose tissue phenotype ("bad fat" to "good fat"), both alone and on top of GLP-1 and GLP-1/GIP agonists. In combination with GLP-1/GIP dual agonist tirzepatide, the synergistic transformation of subcutaneous adipose tissue includes dramatic reduction in adipocyte size and increase in "beiging." Selectively targeting MPC – while avoiding PPAR-γ activation – CIR-0602K harnesses the real-world proven efficacy of 1st generation insulin sensitizers, such as pioglitazone, but without their side effect concerns.
Directly correcting a major underlying pathophysiology of chronic metabolic disease, CIR-0602K has the potential to become a cornerstone of therapy. Coupling this potent pharmacology with that of the GLP-1s could particularly benefit people with T2D, T1D, obesity/overweight, MASH and other cardiometabolic diseases.
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SOURCE Cirius Therapeutics
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