NCT07296484ClinicalTrials.gov

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 21 500 participants recherchés61 sites1 pays

Catégories

Endocrinien et métabolique88%Oncologie12%

Enregistré dans 1 registre

ClinicalTrials.govNCT07296484Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 semaines

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Not stated: Registered after enrolment began (about 23 days after the recorded start)First posted 2025-12-22; recorded start 2025-11-29
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 10 other studies in this databaseCounted from the lead sponsor named in the record (Sparrow Pharmaceuticals)
Not stated: 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.

Résumé

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.

Affections

Type 2 Diabetes
Cortisol Excess

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 2
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	OTHER
Insu	QUADRUPLE (4)
Recrutement	1 500 participants recherchés

Promoteur et collaborateurs

Sparrow Pharmaceuticals Promoteur

Groupes et 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

Médicament Placebo
Placebo
Médicament clofutriben
HSD-1 inhibitor

Critères de jugement

Critère de jugement principal
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.
Délai 8-10 hours after the dexamethasone 1 mg dose.
Critère de jugement principal
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.
Délai 24 weeks.
Critère de jugement secondaire
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.
Délai 24 weeks
Autre critère de jugement
To evaluate the safety of clofutriben in participants with T2D and EC.
Frequency of TEAEs (treatment-emergent adverse even) by clofutriben dose
Délai From enrollment until end of trial 9 month

Dates

Dates
Date de début	29 novembre 2025 (réelle)
Achèvement principal	31 décembre 2027 (estimée)
Achèvement	30 juin 2028 (estimée)
Première publication	22 décembre 2025 (réelle)
Dernière mise à jour	9 septembre 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	septembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

59 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Albany Medical College	Albany	New York	Pas encore en recrutement
Velocity Clinical Research, Anderson	Anderson	South Carolina	En recrutement
Emory University School of Medicine	Atlanta	Georgia	En recrutement
Velocity Clinical Research, Austin	Austin	Texas	En recrutement
Paradigm Clinical Research - Boise, ID	Boise	Idaho	En recrutement
Arizona Clinical Trials - Pecos	Chandler	Arizona	En recrutement
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	En recrutement
Chicago Clinical Research Institute	Chicago	Illinois	En recrutement
Velocity Clinical Research - Cincinnati, Blue Ash	Cincinnati	Ohio	En recrutement
Velocity Clinical Research, Cincinnati, Mt. Auburn	Cincinnati	Ohio	En recrutement
IACT Health-Brookstone Centre Pkwy	Columbus	Georgia	En recrutement
Endocrinology Associates, Inc	Columbus	Ohio	En recrutement
Remington Davis, Inc	Columbus	Ohio	En recrutement
Velocity Clinical Research - Dallas	Dallas	Texas	En recrutement
Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida	En recrutement
St. Elizabeth Healthcare	Edgewood	Kentucky	En recrutement
Willamette Valley Clinical Studies	Eugene	Oregon	En recrutement
The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	En recrutement
Ark Clinical Research - Fountain Valley	Fountain Valley	California	En recrutement
Physicians East	Greenville	North Carolina	En recrutement
Juno Research, LLC	Houston	Texas	En recrutement
Velocity Clinical Research, Huntington Park	Huntington Park	California	En recrutement
Velocity Clinical Research - Gardena	La Mesa	California	En recrutement
Velocity Clinical Research, Lafayette	Lafayette	Louisiana	En recrutement
Radiance Clinical Research	Lampasas	Texas	En recrutement
Palm Research Center, Inc.	Las Vegas	Nevada	En recrutement
Alliance Clinical - Las Vegas	Las Vegas	Nevada	En recrutement
Alliance Clinical - Lewisville (Epic Clinical Research)	Lewisville	Texas	En recrutement
Velocity Clinical Research, Lincoln	Lincoln	Nebraska	En recrutement
Ark Clinical Research - Long Beach	Long Beach	California	En recrutement
Velocity Clinical Research, Los Angeles	Los Angeles	California	En recrutement
Los Angeles Institute for Metabolic Research	Los Angeles	California	En recrutement
NOLA Care Clinical Research	Metairie	Louisiana	En recrutement
Admed Research LLC	Miami	Florida	En recrutement
Texas Valley Clinical Research - Mission, TX	Mission	Texas	En recrutement
Lucas Research Inc	Morehead City	North Carolina	En recrutement
Accellacare Charleston	Mt. Pleasant	South Carolina	En recrutement
Tulane University School of Medicine	New Orleans	Louisiana	En recrutement
Suncoast Clinical Research, Inc	New Port Richey	Florida	En recrutement
Amicis Research Center- Nordhoff	Northridge	California	Actif, sans recrutement
Velocity Clinical Research, Omaha	Omaha	Nebraska	En recrutement
Innovative Research Institute	Port Charlotte	Florida	En recrutement
Progressive Medical Research	Port Orange	Florida	En recrutement
Velocity Clinical Research, Rockville	Rockville	Maryland	En recrutement
Texas Diabetes & Endocrinology, P.A. - Round Rock	Round Rock	Texas	En recrutement
Diabetes & Glandular Disease Clinic, P.A.	San Antonio	Texas	En recrutement
Texas Valley Clinical Research - San Antonio TX	San Antonio	Texas	En recrutement
Alliance Clinical San Diego	San Diego	California	En recrutement
Elevate Clinical Research	Seabrook	Texas	En recrutement
Elixia SISU BHR - Springfield	Springfield	Massachusetts	En recrutement

11 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

9 septembre 2026
Site ajouté
1 site added (61 total)
6061

Registre: ClinicalTrials.gov · NCT########

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