Sparrow Pharmaceuticals Announces Interim CAPTAIN-T2D Data Validating High Prevalence of Elevated Cortisol in Difficult-to-Control Type 2 Diabetes

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 https://sparrowpharma.com/ or follow us on LinkedIn.

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LifeSci Communications
mwhitney@lifescicomms.com

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