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.
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.
Show all 29Show fewer
- 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
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.
- Conditions
- Hypercortisolism, Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo for mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
Part 1 Prevalence Phase: Origin of Hypercortisolism
Percentage of patients with/without abnormal adrenal CT scan.
Measured: Screening
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
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
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.
- First posted16 Mar 2023
- Study start31 Mar 2023
- Primary completion19 Nov 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercortisolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Einhorn, MD, Study director, Corcept Therapeutics
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05772169
- Acronym / sponsor ID
- C-1073-310
- Conditions
- Hypercortisolism, Diabetes Mellitus, Type 2
- Keywords
- Hypercortisolism, Diabetes Mellitus, Type 2 Uncontrolled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone 300 mg | Experimental | Drug: Mifepristone 300 MG [Korlym]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 |
| Placebo | Placebo comparator | Drug: Placebo for mifepristonePatients who meet the entry criteria for the Study C-1073-310 will be randomized to receive placebo for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone 300 MG [Korlym]Mifepristone tablets for once daily oral dosing | Drug | Mifepristone 300 mg |
| Placebo for mifepristonePlacebo tablets for once daily oral dosing | Drug | Placebo |
Primary outcome
Part 1 Prevalence Phase: Prevalence of Hypercortisolism
Time frame: Screening
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.
Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism with Abnormal Adrenal CT Scan
Time frame: Baseline Day 1 to week 24
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.
Part 2 Treatment Phase: Effect of Treatment on Hypercortisolism without Abnormal Adrenal CT Scan
Time frame: Baseline Day 1 to week 24
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.
4 secondary outcomes
Part 1 Prevalence Phase: Origin of Hypercortisolism
Time frame: Screening
Part 1 Prevalence Phase: Patient Characteristics
Time frame: Screening
Part 2 Treatment Phase: Effect of Treatment
Time frame: Baseline Day 1 to week 24
Part 2 Treatment Phase: Effect of Treatment
Time frame: Baseline Day 1 to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 39013654DeFronzo 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.
- Individual participant dataSharing planned: Yes. Upon study completion, results will be presented at relevant scientific congresses and published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Einhorn, MD study director
Corcept Therapeutics
36 sites in 1 country: see every site and its status.
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.