Type 2 DiabetesPhase 2CAPTAIN-T2DNCT07296484
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
A Phase 2 study testing clofutriben in people with Type 2 Diabetes and Cortisol Excess, run by Sparrow Pharmaceuticals at 61 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Cortisol Excess
- What is being tested?
- clofutriben
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 61 sitesUnited States
- Study dates
- 29 Nov 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
United States61 sites, 61 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12203
Mohammed Manager, 518-264-4462, ismailmoh@amc.edu
- Recruiting
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Tim Manager, (864) 965-0190, tpeterson@velocityclinical.com
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30303
Rohit Manager, 404-778-1695, rohit.parab@emory.edu
- Recruiting
Velocity Clinical Research, Austin
Austin, Texas, 78759
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Paradigm Clinical Research - Boise, ID
Boise, Idaho, 83709
Janaie Manager, 208-801-7440, jbounsana@paradigm-research.com
- Recruiting
Arizona Clinical Trials - Pecos
Chandler, Arizona, 85225
Kamila Manager, 480-470-4000, kojeda@azclinicaltrials.com
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Jessica Manager, 984-974-3004, jessica_caffey@med.unc.edu
- Recruiting
Chicago Clinical Research Institute
Chicago, Illinois, 60607
Manognya Clinical Research Manager, 3127913241 ext. 303, manognya@ccrii.us
- Recruiting
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Velocity Clinical Research - Cincinnati, Blue Ash
Cincinnati, Ohio, 45242
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
IACT Health-Brookstone Centre Pkwy
Columbus, Georgia, 31904
kristina Manager, 706.321.0495, kristina.erb@centricityresearch.com
- Recruiting
Endocrinology Associates, Inc
Columbus, Ohio, 43201
Edward Clinical Research Manager, 614-453-9999, ek@endocrinology-associates.com
- Recruiting
Remington Davis, Inc
Columbus, Ohio, 43215
Tsunami Clinical Research Manager, 614-487-2560, Tbrisco@remdavis.com
- Recruiting
Velocity Clinical Research - Dallas
Dallas, Texas, 75230
Tim Manager, (972) 566-8631, tpeterson@velocityclinical.com
- Recruiting
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Amber Manager, 859-655-1567, amber.avery@stelizabeth.com
- Recruiting
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
Patricia Manager, 541-461-0132, drpatb@aol.com
- Recruiting
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Marie Study Coordinator, 954-963-7191 ext. ext 236, mmartin@diabetes-endocare.com
- Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
Lizeth Manager, 323-588-1990, lsuncin@velocityclinical.com
- Recruiting
Physicians East
Greenville, North Carolina, 27834
Kristen Manager, 252-413-6392, ktaylor@physicianseast.com
- Recruiting
Juno Research, LLC
Houston, Texas, 77040
Lian manager, 713-779-5494, lian_ramos@junoresearch.us
- Recruiting
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Tim Manager, 5135799911, tpeterson@velocityclinical.com
- Recruiting
Velocity Clinical Research - Gardena
La Mesa, California, 91942
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Radiance Clinical Research
Lampasas, Texas, 76550
Lauren Clinical Research Manager, 512-556-4130, lgarner@radianceclinical.com
- Recruiting
Alliance Clinical - Las Vegas
Las Vegas, Nevada, 89108
Stephanie Manager, (702) 680-1500, sruvalcaba@allianceclinicalnetwork.com
- Recruiting
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
Raffaela Manager, 702-736-5161, raffaela@palmresearchcenter.com
- Recruiting
Alliance Clinical - Lewisville (Epic Clinical Research)
Lewisville, Texas, 75057
Jessica Manager, (469) 361-8007, jpowell@allianceclinicalnetwork.com
- Recruiting
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, 68510
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Ark Clinical Research - Long Beach
Long Beach, California, 90815
Mike Manager, 562-997-1000, mdelgado@arkclinicalresearch.com
- Recruiting
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
Lourdes Manager, (213) 373-8380, lgaribay@metabolic.la
- Recruiting
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90057
Tim Manager, 5135799911, tpeterson@velocityclinical.com
- Recruiting
NOLA Care Clinical Research
Metairie, Louisiana, 70006
Rosina Manager, 504-427-6324, rosinaducote@gmail.com
- Recruiting
Admed Research LLC
Miami, Florida, 33173
Indiana Manager, 786-687-2882, igonzalez@admedresearch.com
- Recruiting
Texas Valley Clinical Research - Mission, TX
Mission, Texas, 78572
Omar Manager, 9568887400, gonzalez.md@tvcrmission.com
- Recruiting
Lucas Research Inc
Morehead City, North Carolina, 28557
Christina Manager, 252-222-5700, christina.tornes@centricityresearch.com
- Recruiting
Accellacare Charleston
Mt. Pleasant, South Carolina, 29464
Dhruva Manager, (843) 849-1880, dhruva.patel@accellacare.com
- Recruiting
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Neha Manager, 5049889803, nupadhyay@tulane.edu
- Recruiting
Suncoast Clinical Research, Inc
New Port Richey, Florida, 34652
Cathy Manager, 727-849-4131, cbarnes@suncoastclinicalresearch.com
- Recruiting
Amicis Research Center- Nordhoff
Northridge, California, 98433
Veronica Clinical Research Manager, (818) 929-7774, veronica.macias@amicisresearch.com
- Recruiting
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Innovative Research Institute
Port Charlotte, Florida, 33952
Lauren Manager, (+1) 2832276233, l.ellis@medpace.com
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Nora Clinical Research Manager, 386-304-7070 ext. 3457, norab@progressivemedicalresearch.com
- Recruiting
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Tim Manager, 513-673-4057, tpeterson@velocityclinical.com
- Recruiting
Texas Diabetes & Endocrinology, P.A. - Round Rock
Round Rock, Texas, 78681
Olivia Clinical Research Manager, 512-334-3505, knutty@tderesearch.com
- Recruiting
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Myriam Manager, 210-614-8612 ext. 1532, myriam.turner@dgdclinic.com
- Recruiting
Texas Valley Clinical Research - San Antonio TX
San Antonio, Texas, 78251
Diana Manager, 2105431990, diana@tvcrtrials.com
- Recruiting
Alliance Clinical San Diego
San Diego, California, 92120
Sandra Manager, (858) 299-0009, SMisic@allianceclinicalnetwork.com
- Recruiting
Elevate Clinical Research
Seabrook, Texas, 77586
Olga Clinical Research Manager, 832-271-1598, olga.konshina@elevateclinical.com
- Recruiting
Elixia SISU BHR - Springfield
Springfield, Massachusetts, 011030
Darlene Manager, 5617970336, darlene.djaba@empathxresearch.com
- Recruiting
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435
Tim Manager, (757) 996-4200, tpeterson@velocityclinical.com
- Recruiting
Oakland Medical Research Center
Troy, Michigan, 48085
Juliejo (Julie) Clinical Research Manager, 248-687-7412, juliejolafave@msn.com
- Recruiting
Arizona Clinical Trials - Broadway
Tucson, Arizona, 85711
Leanne Manager, 480-470-4000, lbuchenholz@azclinicaltrials.com
- Recruiting
Conquest Research
Vienna, Virginia, 22182
Henry Manager, 703-372-3268, Henry.Tran@conquestresearch.com
- Recruiting
Texas Valley Clinical Research, LLC
Weslaco, Texas, 78596
Czarina Manager, 956-431-8090, czarina@tvcrtrials.com
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
Tom Manager, 610-891-9024, tfrancis@suburbanresearch.com
- Recruiting
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50226
Crystal Manager, 515-207-7486, choffman@iderc.com
- Recruiting
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Tim Clinical Research Manager, 5135799911, tpeterson@velocityclinical.com
- Recruiting
Alliance for Multispecialty Research - Wichita East
Wichita, Kansas, 67226
Terry Manager, 316-689-6635, terry.klein@amr-clinical.com
- Recruiting
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Kevin Manager, 910.815.6108, cannon1099@me.com
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Malisa Manager, 407-916-0060, malisa.agard@conquestresearch.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Type 2 Diabetes, Cortisol Excess
- Being tested
- clofutriben, Placebo
- Keywords
- hypercortisolism, Cortisol excess, elevated cortisol
- Medical subject headings
- Diabetes Mellitus, Type 2, ACTH Syndrome, Ectopic, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofutribenDrug
Also called SPI-62, ASP3662
HSD-1 inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | clofutriben .2 mg oral tablet daily Receives: Drug: clofutriben |
| Dose 2 | Experimental | clofutriben 2mg oral tablet daily Receives: Drug: clofutriben |
| Dose 3 | Experimental | clofutriben 6mg oral tablet daily Receives: Drug: clofutriben |
| Dose 4 | Experimental | clofutriben 12 mg oral tablet daily Receives: Drug: clofutriben |
| placebo | Placebo comparator | placebo control oral tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-10 hours after the dexamethasone 1 mg dose.
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.
Measured: 24 weeks.
Secondary outcomes (1)
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start29 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sparrow Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296484
- Sponsor's protocol ID
- SPI-62-CL-2006
- Acronym
- CAPTAIN-T2D
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
- ClinicalTrials.gov ID
- NCT07296484
- Acronym / sponsor ID
- CAPTAIN-T2D / SPI-62-CL-2006
- Conditions
- Type 2 Diabetes, Cortisol Excess
- Keywords
- hypercortisolism, Cortisol excess, elevated cortisol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: clofutribenclofutriben .2 mg oral tablet daily |
| Dose 2 | Experimental | Drug: clofutribenclofutriben 2mg oral tablet daily |
| Dose 3 | Experimental | Drug: clofutribenclofutriben 6mg oral tablet daily |
| Dose 4 | Experimental | Drug: clofutribenclofutriben 12 mg oral tablet daily |
| placebo | Placebo comparator | Drug: Placeboplacebo control oral tablet daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- From Screening 1
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clofutribenAlso: SPI-62, ASP3662HSD-1 inhibitor | Drug | Dose 1, Dose 2, Dose 3, Dose 4 |
| PlaceboPlacebo | Drug | placebo |
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.
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.
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.
1 secondary outcome
Fasting plasma glucose (mmol/L) change from baseline to Week 24 by treatment.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ark Clinical Research - Fountain Valley
Fountain Valley, United States
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clofutriben in people with Type 2 Diabetes and Cortisol Excess, run by Sparrow Pharmaceuticals at 61 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.