Wisevoter
Boston

Sparrow Adds Cohorts to Clofutriben Diabetes Trial

Sparrow Pharmaceuticals has expanded its Phase 2b CAPTAIN-T2D study of clofutriben to include patients with lower cortisol levels.

Updated on Nov. 5, 2026 in Diabetes

Plain amber glass vials and a single white tablet on a clean laboratory bench, with a soft window showing a brick and glass building outside.
Sparrow Pharmaceuticals has added approximately 80 patients with low cortisol levels to its Phase 2b trial of clofutriben, an oral drug for type 2 diabetes. AI Illustration. Upload story photo >

Sparrow Pharmaceuticals announced the addition of expansion cohorts to its Phase 2b CAPTAIN-T2D trial of clofutriben, an oral HSD-1 inhibitor being tested in type 2 diabetes. The expansion will enroll approximately 80 additional patients with post-DST cortisol at or below 1.8 µg/dL.

Why it matters

The expansion tests whether clofutriben's efficacy and safety extend across the full range of cortisol levels in inadequately controlled type 2 diabetes. HSD-1 inhibition targets a biological pathway that current standards of care do not address.

The original cohorts enroll up to approximately 210 patients with post-DST cortisol above 1.8 µg/dL, while the expansion adds about 80 patients at or below that threshold, randomized 4:1 to clofutriben 12 mg or placebo. Interim ENDO 2026 screening of 397 patients found 77.1% had cortisol at or above 0.9 µg/dL, and whether the lower-cortisol group responds to treatment remains unknown until topline data arrive.

The players

Sparrow Pharmaceuticals

Sparrow Pharmaceuticals is a company developing clofutriben, an oral HSD-1 inhibitor for type 2 diabetes, and is sponsoring the CAPTAIN-T2D trial.

The details

The expansion cohorts will be randomized independently of the main cohort, 4:1, to clofutriben 12 mg once daily or placebo. The trial's primary endpoint is change from baseline in HbA1c at Week 24, and Part 1 screening is expected to evaluate up to approximately 1,500 patients with T2D and EC risk factors.

Timeline

  1. November 5, 2026: Sparrow announces the expansion cohorts to CAPTAIN-T2D.

  2. 2026: Interim trial data is presented at ENDO 2026.

  3. End of 2027: Topline data from all CAPTAIN-T2D cohorts is expected.

Health Landscape

This trial extends the HSD-1 inhibitor research program by testing whether lowering intracellular cortisol helps patients whose disease is not controlled by current standards of care. Its outcome could shape which cortisol threshold future studies use to select patients.

For people with type 2 diabetes whose blood sugar remains above target on current treatment, this trial represents a possible new oral option still years from availability. Patients should continue existing treatment plans and discuss any interest in clinical trials with their physicians.

The takeaway

Trials like CAPTAIN-T2D test whether a drug works beyond the patient group first studied. Results from the lower-cortisol cohort will show whether that group should be included in later treatment decisions.

What happens next

Topline data from the original and expansion CAPTAIN-T2D cohorts is expected by end of 2027.

Further reading

For related coverage, explore Diabetes reporting in Boston.

More information

Details of the study design and enrollment are listed in the ClinicalTrials.gov registry entry for CAPTAIN-T2D.