Cushing SyndromePhase 2NCT03604198
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
A Phase 2 study testing relacorilant in people with Cushing Syndrome, run by Corcept Therapeutics at 48 sites in 10 countries.
Trial summary
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cushing Syndrome
- What is being tested?
- relacorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 48 sitesin 10 countries
- Study dates
- 7 May 2018to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Major Inclusion Criteria:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
- According to the Investigator's opinion will benefit from continuing treatment with relacorilant.
Who cannot join
- Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
Trial locations and contacts
48 sites in 10 countries.
48 sites in 10 countries
United States25 sites
Site 6
Albany, New York, 12206
Site 8
Ann Arbor, Michigan, 48109
Site 10
Atlanta, Georgia, 30318
Site 27
Baltimore, Maryland, 21287
Site 9
Chicago, Illinois, 60611
Site 43
Cleveland, Ohio, 44195
Site 11
Dallas, Texas, 75390
Site 7
El Paso, Texas, 79935
Site 13
Fall River, Massachusetts, 02721
Site 32
Fort Worth, Texas, 76132
Site 12
Houston, Texas, 77079
Site 1
Indianapolis, Indiana, 46202
Site 34
Jackson, Mississippi, 39202
Site 5
Metairie, Louisiana, 70006
Site 50
Miami, Florida, 33136
Site 24
New York, New York, 10021
Site 49
Phoenix, Arizona, 85013
Site 2
Pittsburgh, Pennsylvania, 15212
Site 46
Pittsburgh, Pennsylvania, 15213
Site 55
Reno, Nevada, 89511
Site 36
Rochester, Minnesota, 55905
Site 3
St Louis, Missouri, 63110
Site 35
Stanford, California, 94305
Site 39
Torrance, California, 90502
Site 4
Wilmington, North Carolina, 28401
Italy6 sites
Site 40
Ancona, 60126
Site 44
Messina, 98125
Site 25
Milan, 20145
Site 21
Naples, 80131
Site 48
Padova, 35128
Site 52
Torino
Spain5 sites
Site 53
Alicante
Site 18
Girona
Site 17
Madrid, 28007
Site 38
Málaga, 29006
Site 19
Seville
Romania3 sites
Site 37
Bucharest, 050474
Site 31
Bucharest, 10825
Site 28
Bucharest, 11863
About this study
Official title: An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
Read the detailed description
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
- Conditions
- Cushing Syndrome
- Being tested
- relacorilant
- Keywords
- Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol, Adrenal Corticotropic Hormone (ACTH)
- Medical subject headings
- Cushing Syndrome, Pituitary ACTH Hypersecretion, ACTH Syndrome, Ectopic, Diabetes Mellitus, Type 2, Hypertension, Adrenocortical Carcinoma, Adrenal Cortex Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relacorilantDrug
Also called CORT125134
CORT125134 is supplied as capsules for oral dosing.
| Study group | Role | What they receive |
|---|---|---|
| relacorilant (CORT125134) | Experimental | Not described Receives: Drug: relacorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of relacorilant
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start7 May 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McNally, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604198
- Sponsor's protocol ID
- CORT125134-452
- Other IDs
- 2024-514079-17-00
- Status last verified
- Oct 2026
- First submitted
- 1 May 2018
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
- ClinicalTrials.gov ID
- NCT03604198
- Acronym / sponsor ID
- CORT125134-452
- Conditions
- Cushing Syndrome
- Keywords
- Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jul 2018 (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 an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
Detailed description
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| relacorilant (CORT125134) | Experimental | Drug: relacorilant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Major Inclusion Criteria:
Key exclusion criteria (3 listed)
- Major Exclusion Criteria:
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 |
|---|---|---|
| relacorilantAlso: CORT125134CORT125134 is supplied as capsules for oral dosing. | Drug | relacorilant (CORT125134) |
Primary outcome
Long-term safety of relacorilant
Time frame: 36 months
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
John McNally study director
Corcept Therapeutics
48 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing relacorilant in people with Cushing Syndrome, run by Corcept Therapeutics at 48 sites in 10 countries.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Italy, Spain, Romania, Germany and 5 more countries. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Long-term safety of relacorilant (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.