New drug aims to tackle diabetes by targeting stress hormone

NCT ID NCT07296484

Disease control Sponsor: Sparrow Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This phase 2 trial tests clofutriben, a drug that lowers cortisol, in 1500 adults with hard-to-control type 2 diabetes and signs of high cortisol. Participants receive either clofutriben or a placebo daily for 24 weeks. The study measures changes in blood sugar and cortisol levels to see if the drug helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: clofutriben (a drug that blocks an enzyme involved in cortisol production)
What this could lead to: If it works, this could lead to a new treatment option for people with type 2 diabetes who also have high cortisol levels.
What could go wrong: This is a phase 2 trial, so it's still early. The drug may not improve blood sugar control better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cushing syndrome ectopic ACTH secretion syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cortisol excess Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

60 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Accellacare Charleston
RECRUITING

Mt. Pleasant, South Carolina, 29464, United States
Admed Research LLC
RECRUITING

Miami, Florida, 33173, United States
Albany Medical College
NOT_YET_RECRUITING

Albany, New York, 12203, United States
Alliance Clinical - Las Vegas
RECRUITING

Las Vegas, Nevada, 89108, United States
Alliance Clinical - Lewisville (Epic Clinical Research)
RECRUITING

Lewisville, Texas, 75057, United States
Alliance Clinical San Diego
RECRUITING

San Diego, California, 92120, United States
Alliance for Multispecialty Research - Wichita East
RECRUITING

Wichita, Kansas, 67226, United States
Amicis Research Center- Nordhoff
ACTIVE_NOT_RECRUITING

Northridge, California, 98433, United States
Arizona Clinical Trials - Broadway
RECRUITING

Tucson, Arizona, 85711, United States
Arizona Clinical Trials - Pecos
RECRUITING

Chandler, Arizona, 85225, United States
Ark Clinical Research - Fountain Valley
RECRUITING

Fountain Valley, California, 92708, United States
Ark Clinical Research - Long Beach
RECRUITING

Long Beach, California, 90815, United States
Chicago Clinical Research Institute
RECRUITING

Chicago, Illinois, 60607, United States
Conquest Research
RECRUITING

Winter Park, Florida, 32789, United States
Conquest Research
RECRUITING

Vienna, Virginia, 22182, United States
Diabetes & Glandular Disease Clinic, P.A.
RECRUITING

San Antonio, Texas, 78229, United States
Elevate Clinical Research
RECRUITING

Seabrook, Texas, 77586, United States
Elixia SISU BHR - Springfield
RECRUITING

Springfield, Massachusetts, 011030, United States
Emory University School of Medicine
RECRUITING

Atlanta, Georgia, 30303, United States
Endocrinology Associates, Inc
RECRUITING

Columbus, Ohio, 43201, United States
IACT Health-Brookstone Centre Pkwy
RECRUITING

Columbus, Georgia, 31904, United States
Innovative Research Institute
RECRUITING

Port Charlotte, Florida, 33952, United States
Iowa Diabetes and Endocrinology Research Center
RECRUITING

West Des Moines, Iowa, 50226, United States
Juno Research, LLC
RECRUITING

Houston, Texas, 77040, United States
Los Angeles Institute for Metabolic Research
RECRUITING

Los Angeles, California, 90015, United States
Lucas Research Inc
RECRUITING

Morehead City, North Carolina, 28557, United States
NOLA Care Clinical Research
RECRUITING

Metairie, Louisiana, 70006, United States
Oakland Medical Research Center
RECRUITING

Troy, Michigan, 48085, United States
PMG Research of Wilmington, LLC
RECRUITING

Wilmington, North Carolina, 28401, United States
Palm Research Center, Inc.
RECRUITING

Las Vegas, Nevada, 89148, United States
Paradigm Clinical Research - Boise, ID
RECRUITING

Boise, Idaho, 83709, United States
Physicians East
RECRUITING

Greenville, North Carolina, 27834, United States
Progressive Medical Research
RECRUITING

Port Orange, Florida, 32127, United States
Radiance Clinical Research
RECRUITING

Lampasas, Texas, 76550, United States
Remington Davis, Inc
RECRUITING

Columbus, Ohio, 43215, United States
St. Elizabeth Healthcare
RECRUITING

Edgewood, Kentucky, 41017, United States
Suburban Research Associates
RECRUITING

West Chester, Pennsylvania, 19380, United States
Suncoast Clinical Research, Inc
RECRUITING

New Port Richey, Florida, 34652, United States
Texas Diabetes & Endocrinology, P.A. - Round Rock
RECRUITING

Round Rock, Texas, 78681, United States
Texas Valley Clinical Research - Mission, TX
RECRUITING

Mission, Texas, 78572, United States
Texas Valley Clinical Research - San Antonio TX
RECRUITING

San Antonio, Texas, 78251, United States
Texas Valley Clinical Research, LLC
RECRUITING

Weslaco, Texas, 78596, United States
The Center for Diabetes and Endocrine Care
RECRUITING

Fort Lauderdale, Florida, 33312, United States
Tulane University School of Medicine
RECRUITING

New Orleans, Louisiana, 70112, United States
University of North Carolina at Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27514, United States
Velocity Clinical Research - Cincinnati, Blue Ash
RECRUITING

Cincinnati, Ohio, 45242, United States
Velocity Clinical Research - Dallas
RECRUITING

Dallas, Texas, 75230, United States
Velocity Clinical Research - Gardena
RECRUITING

La Mesa, California, 91942, United States
Velocity Clinical Research, Anderson
RECRUITING

Anderson, South Carolina, 29621, United States
Velocity Clinical Research, Austin
RECRUITING

Austin, Texas, 78759, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
RECRUITING

Cincinnati, Ohio, 45219, United States
Velocity Clinical Research, Huntington Park
RECRUITING

Huntington Park, California, 90255, United States
Velocity Clinical Research, Lafayette
RECRUITING

Lafayette, Louisiana, 70508, United States
Velocity Clinical Research, Lincoln
RECRUITING

Lincoln, Nebraska, 68510, United States
Velocity Clinical Research, Los Angeles
RECRUITING

Los Angeles, California, 90057, United States
Velocity Clinical Research, New Smyrna Beach
RECRUITING

Edgewater, Florida, 32132, United States
Velocity Clinical Research, Omaha
RECRUITING

Omaha, Nebraska, 68134, United States
Velocity Clinical Research, Rockville
RECRUITING

Rockville, Maryland, 20854, United States
Velocity Clinical Research, Salt Lake City
RECRUITING

West Jordan, Utah, 84088, United States
Velocity Clinical Research, Suffolk
RECRUITING

Suffolk, Virginia, 23435, United States
Willamette Valley Clinical Studies
RECRUITING

Eugene, Oregon, 97404, United States

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