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NCT07296484ClinicalTrials.gov

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

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…

Phase 21,500 participants sought61 sites1 country

Categories

Endocrine & metabolic88%Oncology12%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 23 days after the recorded start)First posted 2025-12-22; recorded start 2025-11-29
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 10 other studies in this databaseCounted from the lead sponsor named in the record (Sparrow Pharmaceuticals)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 60 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,500 participants (target), run at 61 sites.

How this score is built
  • Enrolment32/40

    1,500 participants (target)

  • Site count21/25

    60 sites

  • Country count0/15

    Single country

  • Planned duration8/10

    Planned over about 31 months

  • Sponsor scale3/10

    Sparrow Pharmaceuticals has led 12 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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).

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

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2
AllocationRandomised
Intervention modelPARALLEL
Primary purposeOTHER
MaskingQUADRUPLE (4)
Enrolment1,500 participants sought

Sponsor and collaborators

  • Sparrow Pharmaceuticals Sponsor

Arms and interventions

  • Dose 1EXPERIMENTAL

    clofutriben .2 mg oral tablet daily

  • Dose 2EXPERIMENTAL

    clofutriben 2mg oral tablet daily

  • Dose 3EXPERIMENTAL

    clofutriben 6mg oral tablet daily

  • Dose 4EXPERIMENTAL

    clofutriben 12 mg oral tablet daily

  • placeboPLACEBO_COMPARATOR

    placebo control oral tablet daily

Interventions

  • Drug Placebo

    Placebo

  • Drug clofutriben

    HSD-1 inhibitor

Outcome measures

  1. Primary outcome

    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.

    To assess prevalence in the trial population of morning cortisol non-suppression by a single dexamethasone 1 mg dose.

    Time frame 8-10 hours after the dexamethasone 1 mg dose.

  2. Primary outcome

    Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment.

    To assess glycated hemoglobin A1c (%) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.

    Time frame 24 weeks.

  3. Secondary outcome

    Fasting plasma glucose (mmol/L) change from baseline to Week 24 by treatment.

    To assess glucose (mmol/L) changes, compared to placebo, in patients who receive each of 4 daily clofutriben doses for 24 weeks.

    Time frame 24 weeks

  4. Other outcome

    To evaluate the safety of clofutriben in participants with T2D and EC.

    Frequency of TEAEs (treatment-emergent adverse even) by clofutriben dose

    Time frame From enrollment until end of trial 9 month

Dates

Start dateNovember 29, 2025 (actual)
Primary completionDecember 31, 2027 (estimated)
CompletionJune 30, 2028 (estimated)
First postedDecember 22, 2025 (actual)
Last updatedSeptember 9, 2026
Results postedNot stated in the registry record
Status last verifiedSeptember 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

59 sites are recruiting

United States

FacilityCityState or regionStatus
Albany Medical CollegeAlbanyNew YorkNot yet recruiting
Velocity Clinical Research, AndersonAndersonSouth CarolinaRecruiting
Emory University School of MedicineAtlantaGeorgiaRecruiting
Velocity Clinical Research, AustinAustinTexasRecruiting
Paradigm Clinical Research - Boise, IDBoiseIdahoRecruiting
Arizona Clinical Trials - PecosChandlerArizonaRecruiting
University of North Carolina at Chapel HillChapel HillNorth CarolinaRecruiting
Chicago Clinical Research InstituteChicagoIllinoisRecruiting
Velocity Clinical Research - Cincinnati, Blue AshCincinnatiOhioRecruiting
Velocity Clinical Research, Cincinnati, Mt. AuburnCincinnatiOhioRecruiting
IACT Health-Brookstone Centre PkwyColumbusGeorgiaRecruiting
Endocrinology Associates, IncColumbusOhioRecruiting
Remington Davis, IncColumbusOhioRecruiting
Velocity Clinical Research - DallasDallasTexasRecruiting
Velocity Clinical Research, New Smyrna BeachEdgewaterFloridaRecruiting
St. Elizabeth HealthcareEdgewoodKentuckyRecruiting
Willamette Valley Clinical StudiesEugeneOregonRecruiting
The Center for Diabetes and Endocrine CareFort LauderdaleFloridaRecruiting
Ark Clinical Research - Fountain ValleyFountain ValleyCaliforniaRecruiting
Physicians EastGreenvilleNorth CarolinaRecruiting
Juno Research, LLCHoustonTexasRecruiting
Velocity Clinical Research, Huntington ParkHuntington ParkCaliforniaRecruiting
Velocity Clinical Research - GardenaLa MesaCaliforniaRecruiting
Velocity Clinical Research, LafayetteLafayetteLouisianaRecruiting
Radiance Clinical ResearchLampasasTexasRecruiting
Palm Research Center, Inc.Las VegasNevadaRecruiting
Alliance Clinical - Las VegasLas VegasNevadaRecruiting
Alliance Clinical - Lewisville (Epic Clinical Research)LewisvilleTexasRecruiting
Velocity Clinical Research, LincolnLincolnNebraskaRecruiting
Ark Clinical Research - Long BeachLong BeachCaliforniaRecruiting
Velocity Clinical Research, Los AngelesLos AngelesCaliforniaRecruiting
Los Angeles Institute for Metabolic ResearchLos AngelesCaliforniaRecruiting
NOLA Care Clinical ResearchMetairieLouisianaRecruiting
Admed Research LLCMiamiFloridaRecruiting
Texas Valley Clinical Research - Mission, TXMissionTexasRecruiting
Lucas Research IncMorehead CityNorth CarolinaRecruiting
Accellacare CharlestonMt. PleasantSouth CarolinaRecruiting
Tulane University School of MedicineNew OrleansLouisianaRecruiting
Suncoast Clinical Research, IncNew Port RicheyFloridaRecruiting
Amicis Research Center- NordhoffNorthridgeCaliforniaActive, not recruiting
Velocity Clinical Research, OmahaOmahaNebraskaRecruiting
Innovative Research InstitutePort CharlotteFloridaRecruiting
Progressive Medical ResearchPort OrangeFloridaRecruiting
Velocity Clinical Research, RockvilleRockvilleMarylandRecruiting
Texas Diabetes & Endocrinology, P.A. - Round RockRound RockTexasRecruiting
Diabetes & Glandular Disease Clinic, P.A.San AntonioTexasRecruiting
Texas Valley Clinical Research - San Antonio TXSan AntonioTexasRecruiting
Alliance Clinical San DiegoSan DiegoCaliforniaRecruiting
Elevate Clinical ResearchSeabrookTexasRecruiting
Elixia SISU BHR - SpringfieldSpringfieldMassachusettsRecruiting

11 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 9, 2026

    Site added

    1 site added (61 total)

    6061

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07296484