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HypercortisolismPhase 4NCT05772169

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

A Phase 4 study testing Mifepristone 300 MG [Korlym] in people with Hypercortisolism and Diabetes Mellitus, Type 2, run by Corcept Therapeutics at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypercortisolism, Diabetes Mellitus, Type 2
What is being tested?
Mifepristone 300 MG [Korlym]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,113 participants
Where
36 sitesUnited States
Study dates
31 Mar 2023to 18 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Has completed Part 1 of the study with post-DST cortisol level of >1.8 μg/dL and dexamethasone level ≥140 ng/dL
  • Will have no change in, or initiation of, diabetes medications within 4 weeks prior to first study drug dose

Who cannot join

  • 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.
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  • 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:
  • Has any change in status of exclusion criteria from Part 1
  • Requires inhaled glucocorticoid use and may require systemic glucocorticoids if their condition deteriorates during study
  • 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
  • Has refractory hypokalemia; must be able to correct to potassium level of ≥4.0 mEq/L before first dose of study drug
  • Has poorly controlled hyperthyroidism/hypothyroidism before first dose of study drug (confirmed by TSH or free thyroxine)
  • Has plans for adrenalectomy or adrenal nodulectomy
  • Has renal insufficiency (eGFR <30 mL/min/1.73m2)
  • Has liver test results >3x ULN (ALT or AST) or bilirubin >1.5x ULN
  • Takes drugs metabolized by CYP3A and CYP3A substrates with narrow therapeutic ranges
  • Receiving systemic corticosteroids that cannot be discontinued
  • Uses hormonal contraceptives
  • Has a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia, or endometrial carcinoma
  • Is pregnant or lactating
  • Has a known hypersensitivity to mifepristone or any of the product components

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites
  • Site 070

    Albany, New York, 12208

  • Site 074

    Ann Arbor, Michigan, 48109

  • Site 009

    Atlanta, Georgia, 30303

  • Site 097

    Atlanta, Georgia, 30318

  • Site 410

    Baltimore, Maryland, 21239

  • Site 067

    Boston, Massachusetts, 02115

  • Site 456

    Cedar Park, Texas, 78613

  • Site 181

    Chapel Hill, North Carolina, 27514

  • Site 436

    Cincinnati, Ohio, 45219

  • Site 042

    Cleveland, Ohio, 44195

  • Site 077

    Columbus, Ohio, 43210

  • Site 195

    Columbus, Ohio, 43215

  • Site 046

    Covington, Kentucky, 41011

  • Site 370

    Dallas, Texas, 75230

  • Site 444

    Edgewater, Florida, 32132

  • Site 407

    Escondido, California, 92025

  • Site 015

    Fort Lauderdale, Florida, 33312

  • Site 379

    Gardena, California, 90247

  • Site 435

    Grants Pass, Oregon, 97527

  • Site 378

    Huntington Park, California, 90255

  • Site 394

    Hyattsville, Maryland, 20782

  • Site 406

    La Jolla, California, 92037

  • Site 371

    Las Vegas, Nevada, 89128

  • Site 373

    Los Angeles, California, 90057

  • Site 408

    Lufkin, Texas, 75904

  • Site 061

    Metairie, Louisiana, 70006

  • Site 377

    New Orleans, Louisiana, 70112

  • Site 205

    New Orleans, Louisiana, 70121

  • Site 049

    Portland, Oregon, 97239

  • Site 054

    San Antonio, Texas, 78207

  • Site 369

    San Antonio, Texas, 78229

  • Site 405

    Seattle, Washington, 98108

  • Site 411

    Smithtown, New York, 11787

  • Site 387

    Tarzana, California, 91356

  • Site 375

    Torrance, California, 90502

  • Site 059

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Study of Hypercortisolism in Patients With Difficult to Control Type 2 Diabetes Despite Receiving Standard-of-Care Therapies: Prevalence and Treatment With Korlym® (Mifepristone) (CATALYST)

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.

Read the detailed 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.

Being tested
Mifepristone 300 MG [Korlym], Placebo for mifepristone
Keywords
Hypercortisolism, Diabetes Mellitus, Type 2 Uncontrolled
Medical subject headings
Cushing Syndrome, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mifepristone 300 MG [Korlym]Drug

    Mifepristone tablets for once daily oral dosing

  • Placebo for mifepristoneDrug

    Placebo tablets for once daily oral dosing

Study groups in NCT05772169
Study groupRoleWhat they receive
Mifepristone 300 mgExperimentalRandomized 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
Receives: Drug: Mifepristone 300 MG [Korlym]
PlaceboPlacebo comparatorPatients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks
Receives: Drug: Placebo for mifepristone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Screening

  2. 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.

    Measured: Baseline Day 1 to week 24

  3. 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.

    Measured: Baseline Day 1 to week 24

Secondary outcomes (4)
  1. Part 1 Prevalence Phase: Origin of Hypercortisolism

    Percentage of patients with/without abnormal adrenal CT scan.

    Measured: Screening

  2. Part 1 Prevalence Phase: Patient Characteristics

    Clinical and/or laboratory characteristics of patients with hypercortisolism and of patients with hypercortisolism with/without abnormal adrenal CT scan.

    Measured: Screening

  3. Part 2 Treatment Phase: Effect of Treatment

    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.

    Measured: Baseline Day 1 to week 24

  4. Part 2 Treatment Phase: Effect of Treatment

    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.

    Measured: Baseline Day 1 to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start31 Mar 2023
  3. Primary completion19 Nov 2024
  4. Study completion18 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772169
Sponsor's protocol ID
C-1073-310
Status last verified
Jan 2025
First submitted
6 Mar 2023
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Upon study completion, results will be presented at relevant scientific congresses and published in a peer-reviewed journal.

Publications

  • 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.

    PubMed 39013654

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mifepristone 300 MG [Korlym] in people with Hypercortisolism and Diabetes Mellitus, Type 2, run by Corcept Therapeutics at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Prevalence Phase: Prevalence of Hypercortisolism (time frame: Screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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