[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sparrow Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100615736","phase-2-trial-against-intractable-type-2-diabetes-captain-t2d-100615736",false,"NCT07296484","Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","CAPTAIN-T2D","Inclusion Criteria:\n\n* From Screening 1\n\n  * Age at least 18 years.\n  * 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).\n  * 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).\n  * Adequate total daily insulin is defined as at least 0.3 units\u002Fkg\u002Fday. 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.\n  * Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.\n  * At least one of the following\n\n    * ≥3 stable and adequate ADMs;\n    * diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);\n    * hypertension requiring ≥2 adequately dosed AHMs;\n    * adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and\n    * adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;\n    * evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);\n    * or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.\n\nAt DST • Post-DST cortisol level \\>1.8 µg\u002FdL and serum dexamethasone ≥140 ng\u002FdL. Patients with an established diagnosis of neoplastic hypercortisolism do not require a DST.\n\nAt Screening 2\n\n* HbA1c ≥7.5% at Screening 2. At Day 1\n* No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.\n\nExclusion Criteria:\n\n* New-onset diabetes (onset \\\u003C1 year in the past).\n* Unwillingness to maintain with current glucose-lowering regimen during the trial.\n* Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.\n* Unwillingness to comply with CGM or other trial procedures.\n* Investigator considers the patient will otherwise be unwilling or unable to complete the trial.\n* Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.\n* 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).\n* Any of the following in medical history:\n\n  * Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);\n  * 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);\n  * Hypersensitivity or severe reaction to dexamethasone;\n  * Pheochromocytoma, or suspicion thereof;\n  * Anorexia, or other eating disorder;\n  * Glucocorticoid resistance;\n  * Multiple sclerosis;\n  * Significant hepatic impairment (e.g., Child-Pugh Class B or C);\n  * Idiopathic thrombocytopenic purpura;\n  * 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);\n  * Current alcohol consumption \\>14 units\u002Fweek or \\>4 units in a single day for males, or \\>7 units\u002Fweek 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);\n  * 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\n  * Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.\n  * Any of the following in medication history:\n  * Any of the excluded medications listed in Section 6.9;\n  * 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;\n  * 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\u002Fdiscontinuation; and\n  * Pregnancy (including a positive urine test) or current breast feeding.\n\nFrom Screening 2\n\n• Prior probability of undiagnosed endogenous Cushing syndrome based on either of:\n\n* wo morning serum cortisol values after dexamethasone suppression \\>5.0 mcg\u002FdL together with plasma dexamethasone \\>140 ng\u002FmL; or\n* a morning serum cortisol value after dexamethasone suppression \\>1.8 mcg\u002FdL, together with plasma dexamethasone \\>140 ng\u002FmL and any one of the following that is not attributable to an etiology other than endogenous Cushing's syndrome:\n* supraclavicular\u002Fdorsocervical fat accumulation;\n* irounding of the face (especially compared with prior photos);\n* skin changes (violaceous striae, skin thinning, or excessive bruising);\n* proximal muscle weakness on exam; or\n* history of deep vein thrombosis\u002Fpulmonary embolism.\n* 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).\n* 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 \\\u003C160\u002F100 mmHg for 1 month on a new stable medication regimen).\n* Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).\n* Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) \\\u003C45 mL\u002Fmin\u002F1.73 m².\n* Poorly controlled hyperthyroidism\u002Fhypothyroidism (confirmed by TSH or Free thyroxine \\[fT4\\]).\n* 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)\n* Known hypersensitivity to clofutriben or to any of the product","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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).",[27,28],"Type 2 Diabetes","Cortisol Excess",[30,31,32],"hypercortisolism","Cortisol excess","elevated cortisol","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-11-29",{"date":41,"type":21},"2028-06-30",{"name":43,"class":44},"Sparrow Pharmaceuticals","INDUSTRY",60,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100610464","phase-1-clofutriben-pharmacokinetics-in-patients-with-impaired-renal-function-100610464","NCT07227922","Clofutriben Pharmacokinetics in Patients With Impaired Renal Function","RENAL","Inclusion Criteria:\n\n* Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate \\[eGFR\\]: 30 to \\\u003C60 mL\u002Fmin) and matched (by sex, age, and weight) control participants with normal renal function (eGFR: ≥90 mL\u002Fmin) will be enrolled in this trial.\n\nExclusion Criteria:\n\n* Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)\u002F vital sign measurements\u002F laboratory test results at Screening and Check-in, will not be enrolled",true,"83 Years",{"count":56,"type":21},16,[58],"PHASE1","This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.",[61],"Moderate Renal Impairment",[63],"Renal","2025-12-22",{"date":66,"type":37},"2025-12-23",{"date":68,"type":37},"2025-11-30",{"date":70,"type":21},"2026-07-01",{"name":43,"class":44},1,""]