Cirius Therapeutics to Highlight Cardiometabolic Benefits of CIR-0602K at Global Cardiovascular Clinical Trialists (CVCT) Forum 2025

Data from Phase 2 Trials Underscore Cardioprotective Potential

GRAND RAPIDS, Mich., Dec. 9, 2025 /PRNewswire/ -- Cirius Therapeutics, Inc., a developer of innovative therapies for people suffering from diseases driven by insulin resistance and metabolic dysfunction, announced today that Robert Beardsley, PhD, Chief Executive Officer, will present a collection of data showcasing the potential of clinical candidate CIR-0602K to improve cardiometabolic risk factors at CVCT 2025.

The presentation on Wednesday, December 8, as part of Incretin-Based Weight Management Medicines - Weight Loss and Muscle Health: Hype or Hope, will feature results from previous Phase 2 trials of CIR-0602K which highlight CIR-0602K's unique ability to address key drivers of cardiovascular health:

• Metabolic and Glycemic Control
  
  
• Improvements in HbA1c (-0.5% to -1.3% in persons not at goal), and reductions in both fasting and postprandial glucose; Elevated HbA1c has been linked to microvascular / macrovascular disease and cardiovascular events^1,2
  
  
• Reductions in insulin resistance and fasting insulin (by up to 50%); Elevated insulin levels have been linked to vascular / ischemic heart disease and MACE (major adverse cardiovascular events)^2,3,4,5
  
  
• These improvements were also observed in trial participants when added on top of stable GLP-1 therapy

• Inflammation
  
  
• Reduced high-sensitivity C-reactive protein (hsCRP) in participants with hsCRP above 3 mg/L at baseline by approximately 40%; person with hsCRP >3 mg/L are at high risk for future cardiovascular events.

• Lipid Profile and other vascular health markers
  
  
• Increased HDL cholesterol
  
  
• Shift in lipoprotein particle subclasses (HDL3 to 2; LDL small to large)
  
  
• Reduced blood pressure and endotropin (ProC6)

• Body Composition
  
  
• Increased lean mass, strength and muscle metabolic activity, including mitigating reductions in these with weight loss therapy. Maintaining healthy muscle is critical to lowering cardiovascular risk, especially in aging, and as reported earlier this year, in diet-induced obese (DIO) mice CIR-0602K offsets GLP-1 associated loss of muscle, strength and mitochondria,⁶
  
  
• Beneficial remodeling of white adipose tissue (WAT), including reducing adipocyte size, shifting from pro-inflammatory to anti-inflammatory, and "beiging" to increase WAT metabolic activity. While the relationship of WAT phenotype to cardiovascular disease is only beginning to be explored, in DIO mice both CIR-0602K and tirzepatide drove this remodeling, including a dramatic synergy when combined.⁷
  
  
• Reduced visceral-to-subcutaneous-fat ratio (V/S ratio) and the amount of ectopic fat. Higher V/S ratio is associated with increased incidence of cardiovascular events, while ectopic fat in organs, including the heart, drives inflammation & poor outcomes. ⁸

The presentation also will discuss cardiovascular endpoints in the recently announced Type 1 Diabetes Phase 2 that may help further illustrate these benefits. 

"Collectively, these data tell a compelling story about the potential impact of CIR-0602K on cardiovascular outcomes," said Dr. Beardsley. "Cardiometabolic health starts at the mitochondria of every cell. As we've already shown with diabetes and MASH, by reprogramming mitochondria to address mitochondrial dysfunction, CIR-0602K also represents a promising approach for patients with or at risk of cardiovascular disease."

In addition to the presentation, Dr. Beardsley will also be participating in a panel discussion "Industry Perspectives on Muscle Sparing/Building Agents During Weight Loss: A "NEED" or a "WANT."

The conference is being held December 8-10 at the Mayflower Hotel in Washington, DC. 

¹ Giugliano, et al., Diab Obes Metab, 2020; ² Harrison, et al., J Hepat, 2020;
³ Despres, et al., NEJM, 1996; ⁴ Kumar, et al., Diab Vasc Dis Res, 2019; ⁵ Harrison, et al., Hepat, 2024; ⁶ Abufarha, et al., ADA Scientific Sessions, 2025; ⁷Abufarha, et al., Obesity Week, 2025; ⁸Fukuda, et al., J Diab Investig, 2018; 

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 1^st 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.

www.CiriusTx.com

Contact:
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SOURCE Cirius Therapeutics