Recruiting

Phase 2

ClofutribenTrial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Sponsor:

Sparrow Pharmaceuticals

Code:

NCT07296484

Conditions

Type 2 Diabetes

Cortisol Excess

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

clofutriben

Placebo

Study Details

Brief 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).

Conditions

Type 2 Diabetes

Cortisol Excess

Study ID

NCT07296484

Start date

Nov 29, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

clofutriben

HSD-1 inhibitor

Placebo

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. ]
Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment. [ Time Frame: 24 weeks. ]

Central Contacts and Locations

Locations

Arizona Clinical Trials - Pecos

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Kamila Manager

480-470-4000 kojeda@azclinicaltrials.com

Arizona Clinical Trials - Broadway

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Leanne Manager

480-470-4000 lbuchenholz@azclinicaltrials.com

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Lizeth Manager

323-588-1990 lsuncin@velocityclinical.com

Velocity Clinical Research, Huntington Park

Recruiting

Huntington Park, California, United States, 90255

Contacts

Tim Manager

5135799911 tpeterson@velocityclinical.com

Velocity Clinical Research - Gardena

Recruiting

La Mesa, California, United States, 91942

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Ark Clinical Research - Long Beach

Recruiting

Long Beach, California, United States, 90815

Contacts

Mike Manager

562-997-1000 mdelgado@arkclinicalresearch.com

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

Contacts

Lourdes Manager

(213) 373-8380 lgaribay@metabolic.la

Velocity Clinical Research, Los Angeles

Recruiting

Los Angeles, California, United States, 90057

Contacts

Tim Manager

5135799911 tpeterson@velocityclinical.com

Amicis Research Center- Nordhoff

Recruiting

Northridge, California, United States, 98433

Contacts

Veronica Clinical Research Manager

(818) 929-7774 veronica.macias@amicisresearch.com

Velocity Clinical Research, New Smyrna Beach

Recruiting

Edgewater, Florida, United States, 32132

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

The Center for Diabetes and Endocrine Care

Recruiting

Fort Lauderdale, Florida, United States, 33312

Contacts

Marie Study Coordinator

954-963-7191 mmartin@diabetes-endocare.com

Admed Research LLC

Recruiting

Miami, Florida, United States, 33173

Contacts

Indiana Manager

786-687-2882 igonzalez@admedresearch.com

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Nora Clinical Research Manager

386-304-7070 norab@progressivemedicalresearch.com

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Rohit Manager

404-778-1695 rohit.parab@emory.edu

IACT Health-Brookstone Centre Pkwy

Recruiting

Columbus, Georgia, United States, 31904

Contacts

kristina Manager

706.321.0495 kristina.erb@centricityresearch.com

Chicago Clinical Research Institute

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Manognya Clinical Research Manager

3127913241 manognya@ccrii.us

Velocity Clinical Research, Sioux City

Recruiting

Sioux City, Iowa, United States, 51106

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50226

Contacts

Crystal Manager

515-207-7486 choffman@iderc.com

St. Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Amber Manager

859-655-1567 amber.avery@stelizabeth.com

Velocity Clinical Research, Lafayette

Recruiting

Lafayette, Louisiana, United States, 70508

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

NOLA Care Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Rosina Manager

504-427-6324 rosinaducote@gmail.com

Tulane University School of Medicine

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Neha Manager

5049889803 nupadhyay@tulane.edu

Velocity Clinical Research, Rockville

Recruiting

Rockville, Maryland, United States, 20854

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Elixia SISU BHR - Springfield

Recruiting

Springfield, Massachusetts, United States, 011030

Contacts

Darlene Manager

5617970336 darlene.djaba@empathxresearch.com

Oakland Medical Research Center

Recruiting

Troy, Michigan, United States, 48085

Contacts

Juliejo (Julie) Clinical Research Manager

248-687-7412 juliejolafave@msn.com

Velocity Clinical Research, Lincoln

Recruiting

Lincoln, Nebraska, United States, 68510

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Velocity Clinical Research, Omaha

Recruiting

Omaha, Nebraska, United States, 68134

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Palm Research Center, Inc.

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

Raffaela Manager

702-736-5161 raffaela@palmresearchcenter.com

Endocrine Associates of Long Island, P.C.

Recruiting

Smithtown, New York, United States, 11787

Contacts

Lisa Manager

631 265-5501 islandendo@aol.com

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jessica Manager

984-974-3004 jessica_caffey@med.unc.edu

Physicians East

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Kristen Manager

252-413-6392 ktaylor@physicianseast.com

Lucas Research Inc

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Christina Manager

252-222-5700 christina.tornes@centricityresearch.com

Velocity Clinical Research, Cincinnati, Mt. Auburn

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Velocity Clinical Research - Cincinnati, Blue Ash

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Endocrinology Associates, Inc

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Edward Clinical Research Manager

614-453-9999 ek@endocrinology-associates.com

Remington Davis, Inc

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Tsunami Clinical Research Manager

614-487-2560 Tbrisco@remdavis.com

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Tom Manager

610-891-9024 tfrancis@suburbanresearch.com

Velocity Clinical Research, Anderson

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Tim Manager

(864) 965-0190 tpeterson@velocityclinical.com

Velocity Clinical Research, Austin

Recruiting

Austin, Texas, United States, 78759

Contacts

Tim Manager

513-673-4057 tpeterson@velocityclinical.com

Velocity Clinical Research - Dallas

Recruiting

Dallas, Texas, United States, 75230

Contacts

Tim Manager

(972) 566-8631 tpeterson@velocityclinical.com

Juno Research, LLC

Recruiting

Houston, Texas, United States, 77040

Contacts

Lian manager

713-779-5494 lian_ramos@junoresearch.us

Radiance Clinical Research

Recruiting

Lampasas, Texas, United States, 76550

Contacts

Lauren Clinical Research Manager

512-556-4130 lgarner@radianceclinical.com

Texas Diabetes & Endocrinology, P.A. - Round Rock

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Olivia Clinical Research Manager

512-334-3505 knutty@tderesearch.com

Diabetes & Glandular Disease Clinic, P.A.

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Myriam Manager

210-614-8612 myriam.turner@dgdclinic.com

Elevate Clinical Research

Recruiting

Seabrook, Texas, United States, 77586

Contacts

Olga Clinical Research Manager

832-271-1598 olga.konshina@elevateclinical.com

Texas Valley Clinical Research, LLC

Recruiting

Weslaco, Texas, United States, 78596

Contacts

Czarina Manager

956-431-8090 czarina@tvcrtrials.com

Velocity Clinical Research, Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Tim Clinical Research Manager

5135799911 tpeterson@velocityclinical.com

Velocity Clinical Research, Suffolk

Recruiting

Suffolk, Virginia, United States, 23435

Contacts

Tim Manager

(757) 996-4200 tpeterson@velocityclinical.com

More Information

Sponsor

Sparrow Pharmaceuticals

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

hypercortisolism
Cortisol excess
elevated cortisol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sparrow Pharmaceuticals on 2026-06-17.