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

NCT05772169 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: C-1073-310
• Study Type: interventional
• Target: 1,113
• Locations: 1 country
• Sites: 36

Brief Summary

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.

Conditions

Hypercortisolism; Diabetes Mellitus, Type 2

Keywords

Hypercortisolism; Diabetes Mellitus, Type 2 Uncontrolled

Outcome Measures

Primary Outcomes (3)

• Part 1 Prevalence Phase: Prevalence of Hypercortisolism

  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.

  Screening

• Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism with Abnormal Adrenal CT Scan

  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.

  Baseline Day 1 to week 24

• Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism without Abnormal Adrenal CT Scan

  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.

  Baseline Day 1 to week 24

Secondary Outcomes (4)

• Part 1 Prevalence Phase: Origin of Hypercortisolism

  Screening

• Part 1 Prevalence Phase: Patient Characteristics

  Screening

• Part 2 Treatment Phase: Effect of Treatment

  Baseline Day 1 to week 24

• Part 2 Treatment Phase: Effect of Treatment

  Baseline Day 1 to week 24

Study Arms (2)

Mifepristone 300 mg

EXPERIMENTAL

Randomized to receive 300 mg mifepristone, titrated to 600 mg mifepristone after 4 weeks with an opportunity to increase to 900 mg mifepristone at week 8 or 12

Drug: Mifepristone 300 MG [Korlym]

Placebo

PLACEBO COMPARATOR

Patients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks

Drug: Placebo for mifepristone

Interventions

Mifepristone 300 MG [Korlym] DRUG

Mifepristone tablets for once daily oral dosing

Mifepristone 300 mg

Placebo for mifepristone DRUG

Placebo tablets for once daily oral dosing

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• For Part 2:

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (36)

Site 407

Escondido, California, 92025, United States

Location

Site 379

Gardena, California, 90247, United States

Location

Site 378

Huntington Park, California, 90255, United States

Location

Site 406

La Jolla, California, 92037, United States

Location

Site 373

Los Angeles, California, 90057, United States

Location

Site 387

Tarzana, California, 91356, United States

Location

Site 375

Torrance, California, 90502, United States

Location

Site 444

Edgewater, Florida, 32132, United States

Location

Site 015

Fort Lauderdale, Florida, 33312, United States

Location

Site 009

Atlanta, Georgia, 30303, United States

Location

Site 097

Atlanta, Georgia, 30318, United States

Location

Site 046

Covington, Kentucky, 41011, United States

Location

Site 061

Metairie, Louisiana, 70006, United States

Location

Site 377

New Orleans, Louisiana, 70112, United States

Location

Site 205

New Orleans, Louisiana, 70121, United States

Location

Site 410

Baltimore, Maryland, 21239, United States

Location

Site 394

Hyattsville, Maryland, 20782, United States

Location

Site 067

Boston, Massachusetts, 02115, United States

Location

Site 074

Ann Arbor, Michigan, 48109, United States

Location

Site 371

Las Vegas, Nevada, 89128, United States

Location

Site 070

Albany, New York, 12208, United States

Location

Site 411

Smithtown, New York, 11787, United States

Location

Site 181

Chapel Hill, North Carolina, 27514, United States

Location

Site 059

Wilmington, North Carolina, 28401, United States

Location

Site 436

Cincinnati, Ohio, 45219, United States

Location

Site 042

Cleveland, Ohio, 44195, United States

Location

Site 077

Columbus, Ohio, 43210, United States

Location

Site 195

Columbus, Ohio, 43215, United States

Location

Site 435

Grants Pass, Oregon, 97527, United States

Location

Site 049

Portland, Oregon, 97239, United States

Location

Site 456

Cedar Park, Texas, 78613, United States

Location

Site 370

Dallas, Texas, 75230, United States

Location

Site 408

Lufkin, Texas, 75904, United States

Location

Site 054

San Antonio, Texas, 78207, United States

Location

Site 369

San Antonio, Texas, 78229, United States

Location

Site 405

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• 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.

  PMID: 39013654 DERIVED

MeSH Terms

Conditions

Cushing Syndrome; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Daniel Einhorn, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: March 31, 2023
• Primary Completion: November 19, 2024
• Study Completion: December 18, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (36)