Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Conditions

• Cortisol Excess
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• clofutriben — DRUG
  HSD-1 inhibitor
• Placebo — DRUG
  Placebo

Study Details

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).

Key Dates

Start date

Nov 29, 2025

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Dose 1
  clofutriben .2 mg oral tablet daily
• Experimental: Dose 2
  clofutriben 2mg oral tablet daily
• Experimental: Dose 3
  clofutriben 6mg oral tablet daily
• Experimental: Dose 4
  clofutriben 12 mg oral tablet daily
• Placebo Comparator: placebo
  placebo control oral tablet daily

Primary Outcome Measure

Percentage of patients with both morning serum cortisol >1.8 mg/dL and morning plasma dexamethasone >=140 ng/dL (single composite endpoint) after a single dexamethasone 1 mg dose taken the prior night. [ Time Frame: 8-10 hours after the dexamethasone 1 mg dose. ]

Locations (52)

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