Clofutriben

More than 75% of patients screened show elevated cortisol level associated with increased prevalence of cardiovascular disease Inadequate glycemic control despite incretin mimetic use and concomitant hypertension were associated with higher levels of cortisol BOSTON, June 15, 2026 (GLOBE NEWSWIRE) -- Sparrow Pharmaceuticals, Inc., a targeted cardiometabolic therapeutics company, today announced interim data from Part 1 of the Phase 2b CAPTAIN-T2D evaluating the prevalence of elevated cortisol (EC) in difficult-to-control Type 2 diabetes (T2D). The data were presented in a late-breaking poster presentation at the Endocrine Society’s Annual Meeting (ENDO 2026), from June 13–16, 2026, in Chicago, Illinois. Among 397 participants screened as of the cutoff date, 25.4% exhibited morning serum cortisol >1.8 µg/dL following a 1 mg overnight dexamethasone suppression test (DST), closely aligned with previously published research. 54.2% had an EC level of ≥1.2 µg/dL, also comparable to a previous study in which this level was found to be associated with higher cardiometabolic risk. The company also presented the proportion with an EC level of ≥0.9 µg/dL as 77.1%, as this is a level that has been reported to be associated with an increased prevalence of cardiovascular disease. An additional important finding, also consistent with previous results, was that patients with inadequately controlled T2D who also had hypertension or were using an incretin agonist were more likely to have higher levels of cortisol. “These data show that elevated cortisol is highly prevalent in patients with difficult-to-control Type 2 diabetes, and that certain easily identifiable clinical characteristics appear to further predict for higher cortisol production,” said Elena A. Christofides, M.D., FACE, Founder of Endocrinology Associates in Columbus, Ohio, and medical advisor to Sparrow Pharmaceuticals. “CAPTAIN-T2D is helping us better understand how cortisol may contribute to treatment resistance and whether targeting cortisol may help us to improve outcomes for patients who remain uncontrolled despite existing therapies.” Cortisol plays an important role in regulating carbohydrates, lipids, and blood pressure – key components of cardiometabolic health. However, when in excess, cortisol can contribute to insulin resistance, dyslipidemia, hypertension, adiposity, and other morbidities, and may make disease harder to manage with current antidiabetic therapies. “Together with the Phase 2a data also being presented at this conference showing clofutriben’s impact on glycemic control and other cardiometabolic factors in patients with T2D, with numerically larger improvements in patients with known clinical risk factors for EC, these findings strengthen our view that clofutriben could address a major unmet medical need in cardiometabolic disease,” said Robert Jacks, President & Chief Executive Officer of Sparrow Pharmaceuticals. Clofutriben is a once-daily oral HSD-1 inhibitor designed to downregulate local cortisol production in metabolically active tissues, including the liver, adipose, muscle, and pancreas. In prior clinical studies, clofutriben improved glycemic control in patients with T2D and was associated with improvements in glycemic control and other cardiometabolic parameters in individual patients with ACTH-dependent Cushing’s syndrome. About CAPTAIN-T2D CAPTAIN-T2D is a double-blind, Phase 2b trial evaluating clofutriben, a selective inhibitor of 11β-hydroxysteroid dehydrogenase type-1 (HSD-1), to improve glycemic control and metabolic health in patients who have difficult-to-control type 2 diabetes (T2D) with elevated cortisol (EC). The trial is taking place in two parts. Part 1 (Screening) is evaluating patients with T2D and EC risk factors for trial eligibility and the presence of EC. Participants deemed eligible from Part 1 are being randomized to either clofutriben or placebo in the dose-ranging, interventional Part 2 (Treatment). The primary endpoint is change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints include changes in body weight, blood pressure, cholesterol, and bone metabolism biomarkers. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals is a targeted cardiometabolic therapeutics company delivering breakthrough solutions for the millions of patients who struggle to control diabetes, obesity, hypertension, and related conditions with current therapies. The Company’s lead candidate, clofutriben, is a novel, once-daily, oral HSD-1 inhibitor currently in Phase 2b development for inadequately controlled type 2 diabetes with elevated cortisol, a large population with high unmet needs. HSD-1 inhibition is a novel mechanism that complements existing agents by addressing an underlying cause of disease progression and treatment resistance across a spectrum of metabolic dysfunction. Clofutriben has been associated with improved glycemic control and other metabolic improvements while generally safe and well tolerated in multiple clinical trials without requiring dose titration. To learn more, visit or follow us on LinkedIn . Media Contacts Maggie Whitney LifeSci Communications mwhitney@lifescicomms.com

Clofutriben improved HbA1c and other cardiometabolic parameters in patients with Type 2 diabetes in a 6-week, placebo-controlled, randomized Phase 2 trial Subset of participants with elevated cortisol (EC) risk factors showed numerically greater improvements in glycemic control and lipid parameters, along with benefits on blood pressure and body weight BOSTON, June 08, 2026 (GLOBE NEWSWIRE) -- Sparrow Pharmaceuticals, Inc., a targeted cardiometabolic therapeutics company, today announced positive Phase 2 clinical data for clofutriben, its lead investigational 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in adults with Type 2 diabetes (T2D) at the 2026 Annual American Diabetes Association (ADA) Scientific Session. In the intent-to-treat (ITT) population, clofutriben produced statistically significant improvements in HbA1c and total cholesterol. In a subset of patients with clinical features associated with a greater risk of having elevated cortisol, including inadequately controlled HbA1c despite treatment with two or more antidiabetic medications (EC-risk factor enriched), numerically larger improvements were observed across all cardiometabolic parameters, including HbA1c, glucose, total cholesterol, triglycerides, weight, and blood pressure. The data comes from a 6-week, randomized, double-blind, placebo- and active-controlled Phase 2 clinical trial ( NCT02372578 ) originally intended to evaluate the effects of clofutriben on neuropathic pain in adults with T2D. “These Phase 2 data reinforce our conviction that clofutriben could play an important role in improving not only glycemic control but also broad cardiometabolic dysfunction,” said Robert Jacks, President & CEO of Sparrow Pharmaceuticals. “Clofutriben’s novel mechanism targets cortisol, an often-overlooked driver of treatment resistance and disease progression, providing the potential to be a therapeutic option for patients whose needs are not addressed by current therapies. We are excited about our ongoing Phase 2b trial (CAPTAIN-T2D) evaluating clofutriben in patients with inadequately controlled T2D and EC and are planning for expansion into other high unmet need cardiometabolic indications.” Type 2 diabetes affects more than 37 million people in the U.S., and half of those are currently inadequately controlled. Furthermore, at least half of patients with difficult-to-control T2D have elevated cortisol at a level associated with increased cardiometabolic risk. Clofutriben is a potent and selective HSD-1 inhibitor that reduces intracellular cortisol in metabolically active tissues. Key findings from the Phase 2 trial include: Intent-to-treat population (N=75): Statistically significant placebo-adjusted reductions in HbA1c (−0.36%), glucose (-1.64 mM), and total cholesterol (−0.76 mM) were observed after 6 weeks of treatment with 10 mg clofutriben once daily. EC risk factor-enriched subset (N=25; HbA1c ≥7.5% and ≥2 antidiabetic medications): Numerically larger improvements were seen across all parameters: HbA1c (−0.51%), glucose (−3.43 mM), total cholesterol (−1.17 mM), triglycerides (−0.86 mM), and weight (−1.3 kg), with small improvements in systolic (−2.4 mmHg) and diastolic (−1.3 mmHg) blood pressure also observed. Safety: No clinically significant safety signals were observed in clinical laboratory measurements, vital signs, or electrocardiogram results. Thrombocytopenia was reported as a treatment-emergent serious adverse event in 1 patient randomized to clofutriben, who had an undisclosed history of idiopathic thrombocytopenic purpura, leading to trial discontinuation. The majority of adverse events (AEs) were mild or moderate in intensity. About CAPTAIN-T2D CAPTAIN-T2D is a double-blind, Phase 2b trial evaluating clofutriben, a selective inhibitor of 11β-hydroxysteroid dehydrogenase type-1 (HSD-1), to improve glycemic control and metabolic health in patients who have difficult-to-control type 2 diabetes (T2D) with elevated cortisol (EC). The trial is taking place in two parts. Part 1 (Screening) is evaluating patients with T2D and EC risk factors for trial eligibility and the presence of EC. Participants deemed eligible from Part 1 are being randomized to either clofutriben or placebo in the dose-ranging, interventional Part 2 (Treatment). The primary endpoint is change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints include changes in body weight, blood pressure, cholesterol, and bone metabolism biomarkers. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals is a targeted cardiometabolic therapeutics company delivering breakthrough solutions for the millions of patients who struggle to control diabetes, obesity, hypertension, and related conditions with current therapies. The Company’s lead candidate, clofutriben, is a novel, once-daily, oral HSD-1 inhibitor currently in Phase 2b development for inadequately controlled type 2 diabetes with elevated cortisol, a large population with high unmet needs. HSD-1 inhibition is a novel mechanism that complements existing agents by addressing an underlying cause of disease progression and treatment resistance across a spectrum of metabolic dysfunction. Clofutriben has been associated with improved glycemic control and other metabolic improvements while generally safe and well tolerated in multiple clinical trials without requiring dose titration. To learn more, visit or follow us on LinkedIn . Media Contacts Maggie Whitney LifeSci Communications mwhitney@lifescicomms.com