Sparrow Pharmaceuticals Starts Phase 2b CAPTAIN-T2D Trial Of Clofutriben In Difficult-To-Control Type 2 Diabetes Patients With Elevated Cortisol

Sparrow Pharmaceuticals, a company focused on developing targeted therapies for cardiometabolic diseases, announced today that the first patient has been enrolled in its Phase 2b clinical trial, CAPTAIN-T2D (NCT07296484), which is evaluating clofutriben for improving glycemic control and metabolic health in patients with difficult-to-control type 2 diabetes (T2D) and elevated cortisol (EC). This patient population represents a prevalent group with significant unmet medical needs.

The CAPTAIN-T2D study is a two-part trial. In the first part, patients with poorly controlled T2D despite multiple antidiabetic medications will be screened for elevated cortisol using a simple overnight dexamethasone suppression test. Eligible participants with elevated cortisol will then enter the second part of the trial, a dose-ranging, interventional study in which they will be randomized to receive different doses of clofutriben or placebo. The primary endpoint of the trial is the change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints will examine changes in additional cardiometabolic measures that can be affected by elevated cortisol, including body weight, blood pressure, cholesterol, and markers of bone formation.

“Cardiovascular disease, often driven by metabolic dysfunction, remains the leading cause of death in both the United States and Europe,” said Robert Jacks, President and Chief Executive Officer of Sparrow Pharmaceuticals. “For the millions of patients who continue to struggle with cardiometabolic disease despite the availability of modern therapies, clofutriben represents a fundamentally different approach. It specifically targets a common but largely overlooked driver of disease progression and treatment resistance.”

Excess cortisol is a well-recognized but underappreciated contributor to metabolic dysfunction across multiple organ systems. High cortisol can cause hyperglycemia, hypertension, weight gain, muscle weakness, dyslipidemia, bone loss, and mood, memory, and sleep disturbances. Clofutriben works by inhibiting HSD-1, reducing cortisol production within key metabolic tissues such as the liver, fat, pancreas, muscle, bone, and brain. This mechanism is complementary to currently approved therapies for cardiometabolic diseases.

Previous Phase 2 studies have shown that clofutriben improves glycemic control in patients with T2D, including those with elevated cortisol due to ACTH-dependent Cushing’s syndrome, while maintaining a favorable safety and tolerability profile. The drug does not require dose titration and has shown no evidence of adrenal insufficiency. Beyond blood sugar improvements, clofutriben has demonstrated benefits in body weight and composition, lipid profiles, blood pressure, bone metabolism markers, sleep, and overall quality of life in individual patients.

Approximately half of patients with T2D do not achieve adequate glycemic control, and up to half of those with difficult-to-control T2D have elevated cortisol levels that increase cardiometabolic risk. Recent studies have shown that these patients can be easily identified through a simple, inexpensive, and widely available test, and that targeting cortisol can improve glycemic control when standard therapies have failed.

“The CAPTAIN-T2D trial represents a precision medicine approach for a well-defined patient population with high unmet needs,” said Frank Czerwiec, M.D., Ph.D., Chief Medical Officer of Sparrow Pharmaceuticals. “Clofutriben targets an underlying factor in glycemic control that current treatments do not address. We are encouraged by the clinical evidence to date and look forward to further evaluating its potential to improve outcomes across multiple metabolic parameters.”