Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 9:34 AM
Study NCT ID:
NCT05772169
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 Prevalence Phase: Prevalence of Hypercortisolism', 'timeFrame': 'Screening', 'description': 'Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) \\>1.8 μg/dL with dexamethasone level ≥140 ng/dL in patients with difficult to control T2D, defined as HbA1c ≥7.5%. despite receiving standard-of-care therapies.'}, {'measure': 'Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism with Abnormal Adrenal CT Scan', 'timeFrame': 'Baseline Day 1 to week 24', 'description': 'Change in HbA1c from baseline (at randomization) to 24 weeks in patients with hypercortisolism and abnormal adrenal CT scan who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo.'}, {'measure': 'Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism without Abnormal Adrenal CT Scan', 'timeFrame': 'Baseline Day 1 to week 24', 'description': 'Change in HbA1c from baseline (at randomization) to 24 weeks in patients with hypercortisolism and normal adrenal CT scan who have difficult to control T2D despite receiving standard of care therapies, treated with mifepristone versus placebo.'}], 'secondaryOutcomes': [{'measure': 'Part 1 Prevalence Phase: Origin of Hypercortisolism', 'timeFrame': 'Screening', 'description': 'Percentage of patients with/without abnormal adrenal CT scan.'}, {'measure': 'Part 1 Prevalence Phase: Patient Characteristics', 'timeFrame': 'Screening', 'description': 'Clinical and/or laboratory characteristics of patients with hypercortisolism and of patients with hypercortisolism with/without abnormal adrenal CT scan.'}, {'measure': 'Part 2 Treatment Phase: Effect of Treatment', 'timeFrame': 'Baseline Day 1 to week 24', 'description': 'Change in anti-diabetes medication from baseline (at randomization) to 24 weeks in patients with hypercortisolism with/without abnormal adrenal CT scan who have difficult to control T2D despite receiving standard-of-care therapies, treated with mifepristone versus placebo.'}, {'measure': 'Part 2 Treatment Phase: Effect of Treatment', 'timeFrame': 'Baseline Day 1 to week 24', 'description': 'Change from baseline (at randomization) to 24 weeks in body weight, body mass index, waist circumference, other glycemic metrics, blood pressure, quality of life, antihypertensive medications, etc. in patients with hypercortisolism with/without abnormal adrenal CT scan treated with mifepristone versus placebo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypercortisolism', 'Diabetes Mellitus, Type 2 Uncontrolled'], 'conditions': ['Hypercortisolism', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '39013654', 'type': 'DERIVED', 'citation': 'DeFronzo RA, Auchus RJ, Bancos I, Blonde L, Busch RS, Buse JB, Findling JW, Fonseca VA, Frias JP, Hamidi O, Handelsman Y, Pratley RE, Rosenstock J, Tudor IC, Moraitis AG, Einhorn D. Study protocol for a prospective, multicentre study of hypercortisolism in patients with difficult-to-control type 2 diabetes (CATALYST): prevalence and treatment with mifepristone. BMJ Open. 2024 Jul 16;14(7):e081121. doi: 10.1136/bmjopen-2023-081121.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult to control T2D despite receiving standard of care therapies.', 'detailedDescription': 'This is a Phase 4 study with 2 parts at approximately 30 sites in the United States (US).\n\nPart 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control T2D (HbA1c ≥7.5%) despite receiving standard-of-care therapies.\n\nPatients from Part 1 Prevalence Phase who meet eligibility requirements can then enroll in Part 2 and will be randomized 2:1 to receive mifepristone or placebo once daily with food. Randomization will be stratified by presence of adenoma (yes/no).\n\nPart 2 (Treatment Phase) is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult to control T2D despite receiving standard of care therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "For Part 1:\n\nInclusion Criteria:\n\nHas difficult to control T2D (HbA1c ≥7.5% and ≤11.5%) based on HbA1c performed at screening.\n\nAND Taking 3 or more anti-hyperglycemic drugs. OR Taking insulin and other anti-hyperglycemic drugs. OR Taking 2 or more anti-hyperglycemic drugs AND a.) the presence of 1 or more micro-vascular or macro-vascular complication (retinopathy, diabetic nephropathy and chronic kidney disease, diabetic neuropathy, atherosclerotic heart disease with diabetes); AND/OR b.) concomitant hypertension requiring 2 or more anti-hypertension medications.\n\n• Women on oral contraceptive pills (OCPs) may be screened but must be willing and able to stop OCPs for at least 3 weeks prior to the dexamethasone suppression test.\n\nExclusion Criteria:\n\n* Has type 1 diabetes mellitus.\n* New-onset diabetes less than 1 year.\n* Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening.\n* Is pregnant or lactating. For women of childbearing potential, have a positive pregnancy test before dexamethasone administration. A woman of childbearing potential includes all women \\<50 years old, women whose surgical sterilization was performed \\<6 months ago, and women who have had a menstrual period in the last 12 months.\n* On hemodialysis or has end-stage renal disease.\n* Has severe untreated sleep apnea as judged by the Investigator.\n* Has excessive alcohol consumption (\\>14 units/week for male, \\>7 units/week for female) as judged by the Investigator.\n* Has severe psychiatric illness by history (such as schizophrenia or dementia) as judged by the Investigator.\n* Has severe medical or surgical illness as judged by the Investigator.\n* Is a night shift worker, i.e., is awake from approximately 11 PM to 7 AM.\n* Has taken any investigational drug within 4 weeks prior to screening, or within less than 5 times the drug's half-life, whichever is longer.\n* Has had the diagnosis of Cushing syndrome or has used or plans to use any of the following treatments for Cushing syndrome:\n\n \\- Mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, pasireotide, long-acting octreotide or pasireotide.\n* Has a history of hypersensitivity or severe reaction to dexamethasone\n\nFor Part 2:\n\nInclusion Criteria:\n\n* Has completed Part 1 of the study with post-DST cortisol level of \\>1.8 μg/dL and dexamethasone level ≥140 ng/dL\n* Will have no change in, or initiation of, diabetes medications within 4 weeks prior to first study drug dose\n\nExclusion Criteria:\n\n* Has any change in status of exclusion criteria from Part 1\n* Requires inhaled glucocorticoid use and may require systemic glucocorticoids if their condition deteriorates during study\n* Has severe, poorly controlled hypertension at screening (defined as mean systolic BP \\>160 mmHg or mean diastolic BP \\>100 mmHg); must be able to correct to a BP of \\<160/100 mmHg before first dose of study drug\n* Has refractory hypokalemia; must be able to correct to potassium level of ≥4.0 mEq/L before first dose of study drug\n* Has poorly controlled hyperthyroidism/hypothyroidism before first dose of study drug (confirmed by TSH or free thyroxine)\n* Has plans for adrenalectomy or adrenal nodulectomy\n* Has renal insufficiency (eGFR \\<30 mL/min/1.73m2)\n* Has liver test results \\>3x ULN (ALT or AST) or bilirubin \\>1.5x ULN\n* Takes drugs metabolized by CYP3A and CYP3A substrates with narrow therapeutic ranges\n* Receiving systemic corticosteroids that cannot be discontinued\n* Uses hormonal contraceptives\n* Has a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia, or endometrial carcinoma\n* Is pregnant or lactating\n* Has a known hypersensitivity to mifepristone or any of the product components"}, 'identificationModule': {'nctId': 'NCT05772169', 'briefTitle': 'Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)', 'organization': {'class': 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daily oral dosing', 'armGroupLabels': ['Mifepristone 300 mg']}, {'name': 'Placebo for mifepristone', 'type': 'DRUG', 'description': 'Placebo tablets for once daily oral dosing', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Site 407', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '90247', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Site 379', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Site 378', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Site 406', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United 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