Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)

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Corcept Therapeutics

Status and phase

Enrolling
Phase 4

Conditions

Diabetes Mellitus, Type 2
Hypercortisolism

Treatments

Drug: Mifepristone 300 MG [Korlym]
Drug: Placebo for mifepristone

Study type

Interventional

Funder types

Industry

Identifiers

NCT05772169
C-1073-310

Details and patient eligibility

About

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.

Full description

This is a Phase 4 study with 2 parts at approximately 30 sites in the United States (US). Part 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. Patients 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). 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has difficult to control T2D (HbA1c ≥7.5% and ≤11.5%) based on HbA1c performed at screening.

AND 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.

Exclusion criteria

  • Has type 1 diabetes mellitus.
  • New-onset diabetes less than 1 year.
  • Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening.
  • 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.
  • On hemodialysis or has end-stage renal disease.
  • Has severe untreated sleep apnea as judged by the Investigator.
  • Has excessive alcohol consumption (>14 units/week for male, >7 units/week for female) as judged by the Investigator.
  • Has severe psychiatric illness by history (such as schizophrenia or dementia) as judged by the Investigator.
  • Has severe medical or surgical illness as judged by the Investigator.
  • Is a night shift worker, i.e., is awake from approximately 11 PM to 7 AM.
  • 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.

Has had the diagnosis of Cushing syndrome or has used or plans to use any of the following treatments for Cushing syndrome:

- Mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, pasireotide, long-acting octreotide or pasireotide.

Has a history of hypersensitivity or severe reaction to dexamethasone

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,000 participants in 2 patient groups, including a placebo group

Mifepristone 300 mg
Experimental group
Description:
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive 600 mg mifepristone for 24 weeks.
Treatment:
Drug: Mifepristone 300 MG [Korlym]
Placebo
Placebo Comparator group
Description:
Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks.
Treatment:
Drug: Placebo for mifepristone

Trial contacts and locations

36

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Central trial contact

Clinical Trial Lead

Data sourced from clinicaltrials.gov

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