Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D) (CAPTAIN-T2D)

May 11, 2026 updated by: Sparrow Pharmaceuticals

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Tucson, Arizona, United States, 85711
    • California
      • Fountain Valley, California, United States, 92708
      • Huntington Park, California, United States, 90255
      • La Mesa, California, United States, 91942
      • Long Beach, California, United States, 90815
      • Los Angeles, California, United States, 90057
      • Los Angeles, California, United States, 90015
        • Recruiting
        • Los Angeles Institute for Metabolic Research
        • Contact:
      • Northridge, California, United States, 98433
    • Florida
      • Edgewater, Florida, United States, 32132
      • Fort Lauderdale, Florida, United States, 33312
        • Recruiting
        • The Center for Diabetes and Endocrine Care
        • Contact:
      • Miami, Florida, United States, 33173
      • New Port Richey, Florida, United States, 34652
      • Port Charlotte, Florida, United States, 33952
        • Not yet recruiting
        • Innovative Research Institute
        • Contact:
      • Port Orange, Florida, United States, 32127
    • Georgia
      • Columbus, Georgia, United States, 31904
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Institute
        • Contact:
          • Manognya Clinical Research Manager
          • Phone Number: 303 3127913241
          • Email: manognya@ccrii.us
    • Iowa
      • Sioux City, Iowa, United States, 51106
      • West Des Moines, Iowa, United States, 50226
        • Recruiting
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • NOLA Care Clinical Research
        • Contact:
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine
        • Contact:
    • Maryland
      • Olney, Maryland, United States, 20832
        • Recruiting
        • Medstar Health Research Institute
        • Contact:
      • Rockville, Maryland, United States, 20854
    • Massachusetts
      • Springfield, Massachusetts, United States, 011030
    • Michigan
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research Center
        • Contact:
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
      • Omaha, Nebraska, United States, 68134
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • Binghamton, New York, United States, 13905
      • Smithtown, New York, United States, 11787
        • Recruiting
        • Endocrine Associates of Long Island, P.C.
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
      • Greenville, North Carolina, United States, 27834
      • Morehead City, North Carolina, United States, 28557
      • Wilmington, North Carolina, United States, 28401
        • Not yet recruiting
        • PMG Research of Wilmington, LLC
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45242
      • Columbus, Ohio, United States, 43201
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington Davis, Inc
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Not yet recruiting
        • Willamette Valley Clinical Studies
        • Contact:
    • South Carolina
      • Anderson, South Carolina, United States, 29621
    • Texas
      • Austin, Texas, United States, 78759
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Emory University School of Medicine
        • Contact:
      • Houston, Texas, United States, 77040
      • Lampasas, Texas, United States, 76550
        • Recruiting
        • Radiance Clinical Research
        • Contact:
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Texas Diabetes & Endocrinology, P.A. - Round Rock
        • Contact:
      • Seabrook, Texas, United States, 77586
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research, LLC
        • Contact:
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical Research, Salt Lake City
        • Contact:
    • Virginia
      • Suffolk, Virginia, United States, 23435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

At DST • Post-DST cortisol level >1.8 µg/dL and serum dexamethasone ≥140 ng/dL. Patients with an established diagnosis of neoplastic hypercortisolism do not require a DST.

At Screening 2

  • 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 Criteria:

  • 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.

From Screening 2

• Prior probability of undiagnosed endogenous Cushing syndrome based on either of:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
clofutriben .2 mg oral tablet daily
Drug: clofutriben
HSD-1 inhibitor
Other Names:
  • SPI-62
  • ASP3662
Experimental: Dose 2
clofutriben 2mg oral tablet daily
Drug: clofutriben
HSD-1 inhibitor
Other Names:
  • SPI-62
  • ASP3662
Experimental: Dose 3
clofutriben 6mg oral tablet daily
Drug: clofutriben
HSD-1 inhibitor
Other Names:
  • SPI-62
  • ASP3662
Experimental: Dose 4
clofutriben 12 mg oral tablet daily
Drug: clofutriben
HSD-1 inhibitor
Other Names:
  • SPI-62
  • ASP3662
Placebo Comparator: placebo
placebo control oral tablet daily
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
To assess prevalence in the trial population of morning cortisol non-suppression by a single dexamethasone 1 mg dose.
8-10 hours after the dexamethasone 1 mg dose.
Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment.
Time Frame: 24 weeks.
To assess glycated hemoglobin A1c (%) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.
24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose (mmol/L) change from baseline to Week 24 by treatment.
Time Frame: 24 weeks
To assess glucose (mmol/L) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of clofutriben in participants with T2D and EC.
Time Frame: From enrollment until end of trial 9 month
Frequency of TEAEs (treatment-emergent adverse even) by clofutriben dose
From enrollment until end of trial 9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sparrow Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-62-CL-2006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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