MSDC-0602K

Breakthrough T1D awarded funding to University of Virginia for placebo-controlled clinical trial in people on automated insulin delivery Evaluating CIR-0602K to tighten glycemic control, reduce insulin usage and improve cardiovascular function Builds on ongoing late-stage development programs in T2D, MASH, and obesity/overweight NEW YORK and GRAND RAPIDS, Mich., Sept. 17, 2025 /PRNewswire/ -- Cirius Therapeutics, Inc., a developer of innovative therapies for people suffering from diseases caused by insulin resistance, and Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes (T1D) research and advocacy organization, today announced that Breakthrough T1D has awarded funding to the University of Virginia School of Medicine for a Phase 2 trial of Cirius' lead candidate, CIR-0602K, a next-generation insulin sensitizer that targets the mitochondrial pyruvate carrier (MPC), in adults living with T1D on a closed loop insulin delivery system. "People living with type 1 diabetes need insulin to live, but insulin alone does not address significant health challenges that can accompany life with type 1 diabetes. New and complementary metabolic therapies that can help individuals manage and improve their glycemic control and address metabolic challenges, like insulin resistance, are needed," said Courtney Ackeifi, PhD, senior scientist at Breakthrough T1D. "Breakthrough T1D is focused on advancing treatments that can improve the lives of those living with type 1 diabetes, and we're excited to support this study of CIR-0602K that represents a promising approach to address the insulin resistance inherent in many people with the disease." Study Overview: This Phase 2a randomized, placebo-controlled, double-blind trial will evaluate three months of 250 mg daily CIR-0602K, an oral next-generation insulin sensitizer that targets the mitochondrial pyruvate carrier (MPC), in adults with T1D who are using closed loop ("automated") insulin delivery. It will explore CIR-0602K's ability to increase the amount of time that glucose can be maintained in a healthy range (time-in-range), the primary endpoint, while reducing the amount of insulin needed. Secondary and exploratory endpoints also include hemoglobin A1c (HbA1c) and various biomarkers of cardiovascular health. Approximately 34 patients are expected to be enrolled at UVA Health. "Even with the latest closed loop 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," said Dr. William B. Horton, MD, Assoc. Professor of Medicine in the University of Virginia School of Medicine's Division of Endocrinology and Metabolism and Principal Investigator for the study. Dr. Horton added, "CIR-0602K has demonstrated an ability to improve insulin sensitivity in other populations, and we believe it could make a meaningful difference for people with T1D. If it can improve their glycemic control while also reducing insulin requirements and addressing associated metabolic dysfunction at the mitochondrial level, CIR-0602K could help achieve better outcomes with fewer complications." Over 300 participants have already received CIR-0602K for up to one year, across seven completed clinical studies. In patients with type 2 diabetes (T2D), MASH and/or obesity, CIR-0602K has shown the ability to significantly improve glycemic control, while also markedly reducing fasting insulin levels. In those studies, it has been well-tolerated and not shown the edema associated with first-generation insulin sensitizers. "CIR-0602K has already shown significant clinical promise in patients with type 2 diabetes and other insulin-resistant conditions, and unique synergies with leading GLP-1 receptor agonists," said Dr. Robert A. Beardsley, PhD, Cirius' President & Chief Executive Officer. "We're thrilled to be partnering with Breakthrough T1D and the University of Virginia School of Medicine to explore whether the impact of this novel mechanism extends to patients living with T1D. The ability to look at its benefits on vascular health in T1D—where, unfortunately, the cardiovascular impacts of mitochondrial dysfunction, and excess glucose and insulin are magnified—may also help illuminate potential CV benefits in T2D, obesity/overweight, and broader metabolic disease." The Phase 2a study is expected to begin enrollment in Q4 2025. About Breakthrough T1D (formerly JDRF) As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About type 1 diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. About Cirius Cirius is a clinical-stage pharmaceutical company focusing on mitochondrial pyruvate carrier (MPC), addressing the metabolic dysfunction that causes insulin resistance and the organ pathologies associated with type 2 diabetes (T2D) 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 markedly 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 in part by Breakthrough T1D is expected to open 4Q25. 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 patients with T2D, obesity/overweight, MASH and other cardiometabolic diseases. 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