Sparrow Pharmaceuticals, Inc. has 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 come from a 6-week, randomised, double-blind, placebo- and active-controlled phase 2 clinical trial 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 glycaemic control but also broad cardiometabolic dysfunction,” said Robert Jacks, president and 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 37m people in the US, 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.
