CAPTAIN-T2D: Clofutriben for Type 2 Diabetes and Cortisol Excess
This study, called CAPTAIN-T2D, is testing a drug called clofutriben against a placebo (an inactive substance) in people with Type 2 Diabetes and elevated cortisol (a stress hormone). Clofutriben is an HSD-1 inhibitor, which means it blocks a specific enzyme. The study aims to see how clofutriben affects blood sugar control (measured by HbA1c) and cortisol levels. You might be able to join if you are at least 18 years old, have Type 2 Diabetes with an HbA1c of 7.5% or higher, and are already taking at least two diabetes medications. The study is currently recruiting up to 1500 participants, but its overall status is unclear.
- Study design
- This is a randomized, double-blind study, meaning you and your doctors won't know if you're receiving clofutriben or placebo. It will involve up to 1500 participants.
- What's involved
- You would first go through a screening period of about 5 to 9 weeks, which includes tests like a dexamethasone suppression test. If eligible, you would then participate in a 24-week treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 24-week treatment period, there will be a follow-up phone call 4 weeks after your last dose of study medication.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07296484
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Recruiting
PHASE2Ages 18+InterventionalSparrow Pharmaceuticals
~1,500 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:clofutribenPlacebo
At a glance
Recruiting sites
48 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 8-10 hours after the dexamethasone 1 mg dose.
+1 more outcome measured
Conditions
Where it's being run
60 sites across 23 statesTexas11
California8
Florida6
North Carolina4
Ohio4
Louisiana3
Arizona2
Georgia2
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
From Screening 1
Age at least 18 years.
HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the current \[as of Screening 1\] regimen).
Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3 months prior to Screening 1 and without change between Screening 1 and Day 1) (An ADM dose will be deemed adequate if it is at or above the maximal labelled dose, or a sub-maximal, but not starting, dose if limited by tolerability (confer with MM if less than half-maximal dose).
Adequate total daily insulin is defined as at least 0.3 units/kg/day. Insulin dose will be deemed stable with adjustments of up to 20% total daily dose during the 3 months prior to Screening 1 or between Screening 1 and Day 1.
Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.
At least one of the following
≥3 stable and adequate ADMs;
diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);
hypertension requiring ≥2 adequately dosed AHMs;
adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and
adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;
evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);
or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.
HbA1c ≥7.5% at Screening 2. At Day 1
No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.
Exclusion
New-onset diabetes (onset \<1 year in the past).
Unwillingness to maintain with current glucose-lowering regimen during the trial.
Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
Unwillingness to comply with CGM or other trial procedures.
Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
Evidence for significant hypoglycemia while on their current diabetic treatment regimen(This includes episodes of symptomatic Level 3 hypoglycemia requiring external assistance for recovery, or CGM-documented prolonged \[\>15 min\] or repeated episodes of either Level 2 hypoglycemia leading to \>1%, or Level 1 hypoglycemia leading to \>4%, in "time below range" within 3 months prior to Screening 1 or between Screening 1 and Day 1).
Any of the following in medical history:
Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);
A hemoglobinopathy or other condition which may interfere with measurement of HbA1c (e.g., sickle cell disease HbSS or other variants HbEE thalassemia, hemolytic anemia, recent blood transfusion);
Hypersensitivity or severe reaction to dexamethasone;
Pheochromocytoma, or suspicion thereof;
Anorexia, or other eating disorder;
Glucocorticoid resistance;
Multiple sclerosis;
Significant hepatic impairment (e.g., Child-Pugh Class B or C);
Idiopathic thrombocytopenic purpura;
Untreated or inadequately controlled moderate-to-severe sleep apnea (apnea-hypopnea index ≥15). (Patients whose condition has been well controlled with Continuous Positive Airway Pressure (CPAP) use for at least 3 months prior to Screening 1 are not excluded. Patients with a STOP-BANG score 5-8 should be referred for a sleep study outside the trial and may rescreen if found not to have moderate-to-severe sleep apnea);
Current alcohol consumption \>14 units/week or \>4 units in a single day for males, or \>7 units/week or \>3 units in a single day for females. (Patients with a CAGE score 2-4 should be evaluated further outside the trial and may be rescreened if found not to have an alcohol \[or other substance\] use disorder);
Untreated or inadequately controlled major depressive disorder, generalized anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia.(Patients whose condition has been well controlled with stable medical therapy, or has been asymptomatic, for at least 3 months prior to Screening 1 are not excluded); or
Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.
Any of the following in medication history:
Any of the excluded medications listed in Section 6.9;
Any investigational drug within 4 weeks or within less than five times the drug's half-life, whichever is longer, prior to Screening 1 or between Screening 1 and Day 1;
Woman of childbearing potential (WOCBP) not willing to adhere to highly effective contraception or strict abstinence for the duration of the trial and for 90 days post completion/discontinuation; and
Pregnancy (including a positive urine test) or current breast feeding.
wo morning serum cortisol values after dexamethasone suppression \>5.0 mcg/dL together with plasma dexamethasone \>140 ng/mL; or
a morning serum cortisol value after dexamethasone suppression \>1.8 mcg/dL, together with plasma dexamethasone \>140 ng/mL and any one of the following that is not attributable to an etiology other than endogenous Cushing's syndrome:
supraclavicular/dorsocervical fat accumulation;
irounding of the face (especially compared with prior photos);
skin changes (violaceous striae, skin thinning, or excessive bruising);
proximal muscle weakness on exam; or
history of deep vein thrombosis/pulmonary embolism.
Plans for, or medically unable to forego, treatment for endogenous Cushing syndrome or ACS within the next 8 months. (For clarity, patients with EnCS or ACS, not having such treatment plans, and medically able to forego treatment for 8 months may enroll if otherwise eligible).
Severe, poorly controlled hypertension (mean systolic BP \>160 mmHg or mean diastolic BP \>100 mmHg) at Screening 2 or between Screening 2 and Day 1, including by at-home monitoring. (Such patients will be eligible to rescreen for Part 2 when they restore BP \<160/100 mmHg for 1 month on a new stable medication regimen).
Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).
Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \<45 mL/min/1.73 m².
Poorly controlled hyperthyroidism/hypothyroidism (confirmed by TSH or Free thyroxine \[fT4\]).
Liver enzymes \>3 × upper limit of normal (ULN) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or bilirubin \>1.5 × ULN.(excepting benign conditions such as Gilbert's)
Known hypersensitivity to clofutriben or to any of the product
What this trial measures
- 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.8-10 hours after the dexamethasone 1 mg dose.
To assess prevalence in the trial population of morning cortisol non-suppression by a single dexamethasone 1 mg dose.
- Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment.24 weeks.
To assess glycated hemoglobin A1c (%) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.