NCT07296484

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).

Detailed description

CAPTAIN-T2D is a two-part, multicenter, randomized, double-blind, parallel group, placebo- controlled trial of the 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor clofutriben. The primary objectives of this trial are to characterize the relationship of clofutriben dose to improved glycemic control, and to identify one or more doses suitable for Phase 3 evaluation, in patients with T2D and elevated cortisol. The trial consists of two parts. Part 1 (Screening) will last between approximately 5 to 9 weeks for most participants. The screening period duration allows for (sequentially) initial eligibility screen, dexamethasone suppression test, and further eligibility assessments. During Part 2 (Treatment), participants will be randomized to placebo or one of four clofutriben doses. Part 2 will last 24 weeks with a follow-up phone call 4 weeks after the last dose of trial medication.

Conditions

• Type 2 Diabetes
• Cortisol Excess

Interventions

Type	Name	Description
DRUG	clofutriben	HSD-1 inhibitor
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-11-29
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2025-12-22
• Last updated: 2026-03-19

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated drug study