Sparrow Pharmaceuticals Announces First Patient Enrolled in Phase 2b Clinical Trial Evaluating Clofutriben for Difficult-to-Control Type 2 Diabetes
Clofutriben is a novel, once-daily, oral HSD-1 inhibitor that reduces excess intracellular cortisol, a new precision approach to a common underlying driver of metabolic dysfunction
Portland, Oregon, January 6, 2026 — Sparrow Pharmaceuticals, a targeted cardiometabolic therapeutics company, today announced that the first patient has been enrolled in its new Phase 2b clinical trial (CAPTAIN-T2D, NCT07296484) evaluating clofutriben to improve glycemic control and metabolic health in patients who have difficult-to-control type 2 diabetes (T2D) with elevated cortisol (EC), a prevalent population with high unmet needs.
CAPTAIN-T2D is a two-part trial. In the first part, patients with poorly controlled T2D despite being on multiple antidiabetic medications will be screened for EC using a simple overnight dexamethasone suppression test. Eligible participants with EC will be randomized to one of several doses of clofutriben or placebo in the dose-ranging, interventional second part of the trial. The primary endpoint is change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints will assess changes in other cardiometabolic parameters that can be impacted by EC including body weight, blood pressure, cholesterol, and bone formation markers.
“Cardiovascular disease, often driven by metabolic dysfunction, remains the leading cause of death in both the US and Europe,” said Robert Jacks, Sparrow President and Chief Executive Officer. “For the millions of patients who still struggle with cardiometabolic disease despite the availability of the newest agents, clofutriben offers a fundamentally different treatment approach by specifically targeting a common but, until now, largely overlooked driver of disease progression and treatment resistance.”
Excess cortisol is a well-understood, but underappreciated, driver of metabolic dysfunction across multiple organ systems that causes a spectrum of morbidity including hyperglycemia, hypertension, weight gain, myopathy, dyslipidemia, and osteopenia, as well as mood, memory, and sleep disturbances. By inhibiting HSD-1, clofutriben reduces cortisol production at the intracellular level in key metabolic tissues such as liver, fat, pancreas, muscle, bone, and brain, a novel treatment mechanism complimentary to current therapies approved for cardiometabolic diseases. In previous phase 2 clinical trials, clofutriben improved glycemic control in patients with T2D, including in individuals with both T2D and elevated cortisol due to ACTH-dependent Cushing’s syndrome, with a favorable safety and tolerability profile. The compound requires no dose titration and has shown no evidence of causing adrenal insufficiency. In addition to glycemic improvements, clofutriben has shown evidence for benefits in individual patients across multiple related metabolic parameters, including body weight and composition, lipids, blood pressure, and bone metabolism markers, as well as sleep and quality of life.
Approximately half of patients suffering from T2D today are not adequately controlled1,2. Up to half of patients with difficult-to-control T2D have an EC level associated with increased comorbidities contributing to cardiometabolic risk3. Recent research has demonstrated both that these patients can be easily identified with a simple, inexpensive, and widely available test, and that a cortisol directed agent can improve glycemic control when polypharmacy with current agents has failed4.
“The CAPTAIN-T2D trial represents a precision approach to a large and well-defined patient population with high unmet needs. Clofutriben’s mechanism targets an underlying contributor to glycemic control challenges that current therapies don’t address,” said Frank Czerwiec, M.D., Ph.D., Chief Medical Officer of Sparrow. “We’re encouraged by the clinical evidence to date and look forward to further evaluating clofutriben’s potential to improve outcomes across multiple metabolic parameters.”