Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPI-62-CL-2006
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 47

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

Keywords

hypercortisolism; Cortisol excess; elevated cortisol

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 weeks.

Secondary Outcomes (1)

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

  24 weeks

Other Outcomes (1)

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

  From enrollment until end of trial 9 month

Study Arms (5)

Dose 1

EXPERIMENTAL

clofutriben .2 mg oral tablet daily

Drug: clofutriben

Dose 2

EXPERIMENTAL

clofutriben 2mg oral tablet daily

Drug: clofutriben

Dose 3

EXPERIMENTAL

clofutriben 6mg oral tablet daily

Drug: clofutriben

Dose 4

EXPERIMENTAL

clofutriben 12 mg oral tablet daily

Drug: clofutriben

placebo

PLACEBO COMPARATOR

placebo control oral tablet daily

Drug: Placebo

Interventions

clofutriben DRUG

HSD-1 inhibitor

Also known as: SPI-62, ASP3662

Dose 1; Dose 2; Dose 3; Dose 4

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (47)

Arizona Clinical Trials - Pecos

Chandler, Arizona, 85225, United States

RECRUITING

Arizona Clinical Trials - Broadway

Tucson, Arizona, 85711, United States

RECRUITING

Ark Clinical Research - Fountain Valley

Fountain Valley, California, 92708, United States

RECRUITING

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

RECRUITING

Velocity Clinical Research - Gardena

La Mesa, California, 91942, United States

RECRUITING

Ark Clinical Research - Long Beach

Long Beach, California, 90815, United States

RECRUITING

Los Angeles Institute for Metabolic Research

Los Angeles, California, 90015, United States

RECRUITING

Velocity Clinical Research, Los Angeles

Los Angeles, California, 90057, United States

RECRUITING

Amicis Research Center- Nordhoff

Northridge, California, 98433, United States

RECRUITING

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, 32132, United States

RECRUITING

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, 33312, United States

RECRUITING

Admed Research LLC

Miami, Florida, 33173, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

IACT Health-Brookstone Centre Pkwy

Columbus, Georgia, 31904, United States

RECRUITING

Chicago Clinical Research Institute

Chicago, Illinois, 60607, United States

RECRUITING

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50226, United States

RECRUITING

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508, United States

RECRUITING

NOLA Care Clinical Research

Metairie, Louisiana, 70006, United States

RECRUITING

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

Medstar Health Research Institute

Olney, Maryland, 20832, United States

RECRUITING

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

RECRUITING

Elixia SISU BHR - Springfield

Springfield, Massachusetts, 011030, United States

RECRUITING

Oakland Medical Research Center

Troy, Michigan, 48085, United States

RECRUITING

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States

RECRUITING

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

RECRUITING

Palm Research Center, Inc.

Las Vegas, Nevada, 89148, United States

RECRUITING

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States

RECRUITING

Endocrine Associates of Long Island, P.C.

Smithtown, New York, 11787, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Physicians East

Greenville, North Carolina, 27834, United States

RECRUITING

Lucas Research Inc

Morehead City, North Carolina, 28557, United States

RECRUITING

Velocity Clinical Research, Cincinnati, Mt. Auburn

Cincinnati, Ohio, 45219, United States

RECRUITING

Velocity Clinical Research - Cincinnati, Blue Ash

Cincinnati, Ohio, 45242, United States

RECRUITING

Endocrinology Associates, Inc

Columbus, Ohio, 43201, United States

RECRUITING

Remington Davis, Inc

Columbus, Ohio, 43215, United States

RECRUITING

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Velocity Clinical Research, Austin

Austin, Texas, 78759, United States

RECRUITING

Emory University School of Medicine

Dallas, Texas, 75230, United States

RECRUITING

Velocity Clinical Research - Dallas

Dallas, Texas, 75230, United States

RECRUITING

Juno Research, LLC

Houston, Texas, 77040, United States

RECRUITING

Radiance Clinical Research

Lampasas, Texas, 76550, United States

RECRUITING

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

Round Rock, Texas, 78681, United States

RECRUITING

Elevate Clinical Research

Seabrook, Texas, 77586, United States

RECRUITING

Texas Valley Clinical Research, LLC

Weslaco, Texas, 78596, United States

RECRUITING

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

RECRUITING

Velocity Clinical Research, Suffolk

Suffolk, Virginia, 23435, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; ACTH Syndrome, Ectopic; Cushing Syndrome

Interventions

ASP3662

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Adrenocortical Hyperfunction; Adrenal Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 22, 2025
• Study Start: November 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (47)